Companies and organisations actively developing psychedelic-based medicines — from early discovery through clinical trials to regulatory approval.
Enterprise Intelligence
Compare indication activity, programme milestones, competitive intensity, and near-term catalysts. Q2 includes quarter-over-quarter changes against the published Q1 baseline.
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Each row represents an active development programme with candidate context. Stage counts use programme phase when available, then candidate stage. Source links are shown directly so sparse or conflicting evidence stays visible.
Rows
157
Sources
919
Forecasts
146
Linked records
16
| Developer / Candidate | Programme | Stage | Latest sourced update | Coverage |
|---|---|---|---|---|
Esketamine MDD with acute suicidal ideation (MDSI) Approved for depressive symptoms in MDD with acute suicidal ideation or behaviour (2020). View profile context | Approved Programme phase | Exploring Esketamine's Therapeutic Outcomes as an FDA-Designated Breakthrough for TRD and MDD With Suicidal Intent: A Narrative Review Publication · Cureus / PubMed Central · Feb 1, 2024 · Verified Milestone: Regulatory review accepted · actual Aug 1, 2016 | 4 sources 2 trials · 0 papers No forecast saved | |
Approved Programme phase | SPRAVATO (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression Press release · Johnson & Johnson · Jan 21, 2025 · Verified Milestone: Regulatory approved · actual Jan 21, 2025 | 9 sources 7 trials · 0 papers No forecast saved | ||
KETARx FDA Approval Programme (Surgical Pain) — ANDA #217858 FDA ANDA #217858 approved August 8, 2025; U.S. commercialisation rights sold December 2025 (upfronts + milestones potentially exceeding $25M) View profile context | Approved Programme phase | PharmaTher announces FDA approval of KETARx ketamine Press release · PharmaTher · Aug 11, 2025 · Verified Milestone: Regulatory approved · actual Aug 8, 2025 | 4 sources 0 trials · 0 papers No forecast saved | |
COMP360 TRD (Phase 3) Rolling NDA submission underway; final submission expected Q4 2026. View profile context | NDA Filed Programme phase | Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile Press release · Compass Pathways · Jul 7, 2026 · Verified Milestone: Phase III completed · actual Jul 7, 2026 | 10 sources 6 trials · 0 papers No forecast saved | |
NRX-100 — IV Ketamine NDA Filing NRx reported on 2026-05-18 that full NRX-100 NDA submission was expected in Q2 2026, with Module 3 already filed and a request for rolling review. PDUFA timing remains TBD until FDA acceptance/review status is announced. View profile context | NDA Filed Programme phase | NRx — Confirms NDA Path After Type C FDA Meeting Press release · NRx Pharmaceuticals · Mar 16, 2026 · Verified Milestone: Regulatory filing submitted | 4 sources 0 trials · 0 papers nda-submitted · likely Q2 2026 Eventual approval estimate: 35% | |
MDMA-AT PTSD — NDA 215455 (Post-CRL) Post-CRL programme remains paused pending a new FDA-aligned Phase 3/resubmission path. Public Lykos materials still describe pursuit of FDA approval, but no new pivotal trial start or resubmission date was found in the June 2026 review. View profile context | NDA Filed Programme phase | Resilient Pharmaceuticals — Company Website company-website · Resilient Pharmaceuticals · Jun 27, 2026 · Verified | 4 sources 3 trials · 2 papers Phase III started Eventual approval estimate: 25% | |
Panorama (GAD Phase 3) Enrollment rapidly progressing; includes US and European sites. Topline data expected H2 2026. View profile context | Phase III Programme phase | Definium Teases Phase III DT120 Data at Leerink Conference Conference · Yahoo Finance · Mar 16, 2026 · Verified | 6 sources 3 trials · 1 papers Phase III topline · likely Q4 2026 Eventual approval estimate: 40% | |
Voyage (GAD Phase 3) Enrollment ~80% complete as of Feb 2026; topline data expected early Q3 2026 View profile context | Phase III Programme phase | Definium Teases Phase III DT120 Data at Leerink Conference Conference · Yahoo Finance · Mar 16, 2026 · Verified | 7 sources 3 trials · 1 papers Phase III topline · likely Q3 2026 Eventual approval estimate: 45% | |
Ascend (MDD Phase 3) Sites activated; first patient dosing anticipated early Q2 2026. ~175 pts (2:1:2 randomization: 100µg, 50µg, placebo). View profile context | Phase III Programme phase | Definium announces positive Phase 3 Emerge topline results for DT120 ODT in MDD Press release · Definium Therapeutics · Jun 22, 2026 · Verified | 3 sources 1 trials · 1 papers Phase III started · likely Q2 2026 | |
Emerge (MDD Phase 3) Fully enrolled (~140 pts). Topline data expected late Q2 2026. View profile context | Phase III Programme phase | Definium Therapeutics Announces Positive Topline Results From Phase 3 EMERGE Study of DT120 ODT in MDD Press release · Definium Therapeutics · Jun 22, 2026 · Verified Milestone: Phase III topline · actual Jun 22, 2026 | 5 sources 1 trials · 1 papers Phase III topline · likely Q2 2026 Eventual approval estimate: 30% | |
BPL-003 TRD (acquired from AtaiBeckley) Indication unknownUS (FDA)Active Programme acquired with AtaiBeckley in July 2026. Development history and milestone detail sit on the AtaiBeckley record; this candidate tracks Lilly ownership from the acquisition onward. View profile context | Phase III Programme phase | No source link saved Latest recorded event: Jul 16, 2026 · Licensing deal | 0 sources 0 trials · 0 papers No forecast saved | |
GH001 TRD — Global Phase 3 Phase 3 global pivotal program planned for 2026 initiation following FDA clinical hold lift (Jan 5, 2026) and positive Phase 2b results View profile context | Phase III Programme phase | GH Research Pipeline Page company-website · GH Research · Jun 27, 2026 · Verified | 7 sources 2 trials · 1 papers Phase III started Eventual approval estimate: 50% | |
PARADIGM — HLP003 Phase 3 (APPROACH + EMBRACE) APPROACH Phase 3 enrollment has surpassed 86%, with dosing ongoing and topline results still expected in Q4 2026. EMBRACE and EXTEND remain part of the broader PARADIGM HLP003 registrational programme. View profile context | Phase III Programme phase | Cybin Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive MDD (SEC Form 6-K) Regulatory filing · SEC / Stock Titan · Jul 21, 2026 · Verified Milestone: Enrollment complete · actual Jul 21, 2026 | 8 sources 0 trials · 0 papers Phase III topline · likely Q4 2026 Eventual approval estimate: 55% | |
NRX-101 — Suicidal Bipolar Depression Accelerated Approval The original suicidal bipolar depression accelerated-approval path remains in preparation, while NRx separately reported FDA expanded-access clearance for NRX-101/TMS and initiation of the pivotal SPARC-TMS study in June 2026. View profile context | Phase III Programme phase | NRx — Phase 2b/3 Promising Findings for NRX-101 (Suicidal Bipolar Depression) Press release · PR Newswire · Mar 1, 2024 · Verified Milestone: Phase III topline · actual Mar 1, 2024 | 3 sources 0 trials · 0 papers nda-submission · likely Q3 2026 Eventual approval estimate: 35% | |
TSND-201 EMPOWER-1 Phase 3 (PTSD) — NCT07456696 EMPOWER-1 Phase 3 recruiting (NCT07456696): 300 patients, two doses vs placebo, 4 weekly oral doses + 8 weeks observation. FDA Breakthrough Therapy Designation July 2025. Otsuka acquisition of Transcend announced March 2026 ($700M upfront + $525M milestones = $1.225B). View profile context | Phase III Programme phase | ClinicalTrials.gov NCT07456696 - EMPOWER-1 TSND-201 PTSD Registry update · ClinicalTrials.gov · Jun 12, 2026 · Verified Milestone: Phase III started | 9 sources 0 trials · 0 papers Forecast saved | |
RECONNECT — RE104 PPD Phase 2→Phase 3 FDA granted Breakthrough Therapy Designation for luvesilocin in PPD on 2026-02-23 after positive RECONNECT Phase 2 data. Reunion says it has aligned with FDA on a registrational path and expects a single pivotal Phase 3 trial in 2026, with the next public watch item being trial registration or first-patient-in. View profile context | Phase III Programme phase | NCT06342310 — RECONNECT Phase 2 (RE104 PPD) clinical-trial-registry · ClinicalTrials.gov · May 14, 2026 · Verified | 5 sources 0 trials · 0 papers Phase III started · likely Q4 2026 Eventual approval estimate: 50% | |
SVN-001 More-KARE Phase 3 (AUD) SVN-001 remains Solvonis lead Phase 3 programme for severe AUD. Solvonis FY2025 results on 2026-04-29 said the board is prioritising advancement through Phase 3 completion; the official SVN-001 page describes the n=280 MORE-KARE trial, Q3 2024 start, trial completion in 2027, data readout in 2028, and possible UK marketing-authorisation submission in 2029. View profile context | Phase III Programme phase | Solvonis pipeline page summarizes SVN-001 Phase 2 alcohol-use-disorder results company-website · Solvonis Therapeutics · Jun 26, 2026 · Verified Milestone: Phase II topline · actual Jan 1, 2021 | 6 sources 0 trials · 0 papers Phase III completed · likely Q4 2027 Eventual approval estimate: 40% | |
R-107 ROCKET Phase 3 Programme (TRD) — Pivotal ROCKET Phase 3 pivotal trial enrollment started H2 2025. BEDROC Phase 2 published in Nature Medicine (2024). 106 patients in open-label compassionate supply >2 years with no dissociation or significant AEs. Raising $175M Series A for Phase 3 and commercialisation. FDA submission targeted 2027. View profile context | Phase III Programme phase | Tasman Therapeutics - R-107 company-website · Tasman Therapeutics · Jun 26, 2026 · Verified Milestone: Phase III started · actual Apr 1, 2025 | 8 sources 0 trials · 0 papers Forecast saved | |
TSND-201 Phase 3 Programme (PTSD) TSND-201 is now in Phase 3 for PTSD. EMPOWER-1 (NCT07456696) is recruiting, with 300 estimated participants and estimated primary completion in December 2027. Transcend published IMPACT-1 Phase 2 data in JAMA Psychiatry, received FDA Breakthrough Therapy Designation in July 2025 and a Commissioner's National Priority Voucher in April 2026, and completed its acquisition by Otsuka in June 2026. View profile context | Phase III Programme phase | Transcend announces completion of acquisition by Otsuka Press release · Transcend Therapeutics · Jun 12, 2026 · Verified Milestone: Funding milestone · actual Mar 27, 2026 | 7 sources 0 trials · 0 papers Phase III topline · likely Q1 2028 | |
uAspire (PSIL301) — Psilocybin MDD Phase 3 uAspire (NCT06308653) remains the active Phase 3 MDD study. Usona has an official Phase 3 sponsor statement on uAspire, and industry reporting in April 2026 said Usona confirmed receipt of an FDA Commissioner National Priority Voucher for psilocybin in MDD. View profile context | Phase III Programme phase | NCT06308653 — uAspire Phase 3 Study (Psilocybin MDD) trial-registry · ClinicalTrials.gov · Jun 1, 2026 · Verified | 6 sources 2 trials · 0 papers nda-submission · likely Q4 2026 Eventual approval estimate: 55% | |
Bretisilocin — Phase 2a MDD (AbbVie/Gilgamesh) AbbVie completed its acquisition of bretisilocin in October 2025. NCT06236880 remains recruiting as an expanded Phase 2a MDD study, with ClinicalTrials.gov listing 124 estimated participants and estimated primary completion in October 2026. View profile context | Phase II Programme phase | AbbVie Neuroscience Pipeline company-website · AbbVie · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Phase II topline · likely Q4 2026 Eventual approval estimate: 40% | |
Phase II Programme phase | Beckley Psytech announces positive results for ELE-101 in depression trial News / media · PharmaTimes · Dec 16, 2024 · Verified Milestone: Phase II topline · actual Dec 16, 2024 | 4 sources 0 trials · 0 papers No forecast saved | ||
APEX-52 — PATHFINDER-52 Phase 2b PTSD (n=294, Canada) APEX-52 remains Apex's take-home microdose psilocybin programme. The current Apex strategy page says APEX is advancing dual drug assets for PTSD/depression and will move to Phase 3 after Phase 2b completion; the 2024 FDA IND filing supported a Yale PK/driving study intended to inform PATHFINDER-52. No 2026 enrollment or topline disclosure was found. View profile context | Phase II Programme phase | Apex Labs — Homepage company-website · Apex Labs · Jun 26, 2026 · Verified | 7 sources 0 trials · 0 papers Phase II topline · likely Q4 2027 | |
APEX-90 — SUMMIT-90 Phase 2b PTSD (n=160, Canada + Israel) SUMMIT-90 Phase 2b remains the active APEX-90 macrodose PTSD/depression programme. Apex expanded the study to two Israeli sites in June 2025, and its current strategy page continues to frame Phase 2b completion as the trigger for Phase 3 and regulatory-approval planning. View profile context | Phase II Programme phase | Apex strategy page identifies APEX-90 as in-clinic macrodose asset and Phase 2b-to-Phase 3 path company-website · Apex Labs · Jun 26, 2026 · Verified | 9 sources 0 trials · 0 papers Phase II topline · likely Q4 2027 | |
ReConnection — BPL-003 TRD Phase 3 Phase 3 ReConnection 1 and ReConnection 2 targeted Q2 2026 following successful EOP2 meeting (March 3, 2026). 8 mg selected as primary dose. View profile context | Phase II Programme phase | AtaiBeckley Investor Relations company-website · AtaiBeckley · Jun 27, 2026 · Verified | 6 sources 0 trials · 1 papers Phase III started Eventual approval estimate: 45% | |
EMP-01 SAD — Phase 2a (UK) Phase 2a complete; positive safety and exploratory efficacy signal. Phase 2b in larger population to follow. View profile context | Phase II Programme phase | AtaiBeckley — Positive EMP-01 Phase 2a Topline Results (SAD) Press release · AtaiBeckley Investor Relations · Feb 26, 2026 · Verified Milestone: Phase II topline · actual Feb 26, 2026 | 3 sources 0 trials · 0 papers Phase II started Eventual approval estimate: 15% | |
ELUMINA — VLS-01 TRD Phase 2 ELUMINA (NCT06524830) is recruiting in treatment-resistant depression. AtaiBeckley reported in May 2026 that the Phase 2 study is progressing as planned, with topline results anticipated in Q4 2026. View profile context | Phase II Programme phase | AtaiBeckley Q1 2026 update: VLS-01 ELUMINA topline expected Q4 2026 company-press-release · AtaiBeckley · May 12, 2026 · Verified | 3 sources 0 trials · 0 papers Phase II topline · likely Q4 2026 Eventual approval estimate: 20% | |
BMND08 Phase 2 Programme (Depression/Anxiety in Alzheimer's) BMND08 Phase 2 completed with positive results reported 2024-02-29. Biomind said it intended to progress BMND08 to Phase 3 and seek Breakthrough Therapy Designation, but the June 2026 source sweep found no public Phase 3 start or BTD outcome. Keep as waiting-on-news. View profile context | Phase II Programme phase | Biomind Labs pipeline page lists BMND08 for Alzheimer’s in Phase II company-website · Biomind Labs · Jun 26, 2026 · Verified Milestone: Regulatory review accepted · actual Dec 1, 2025 | 5 sources 0 trials · 0 papers Phase III started | |
BREAKTHROUGH — BMB-101 Phase 2 (Absence Epilepsy / DEE) Indication unknownUS (FDA)Active Phase 2 BREAKTHROUGH positive (Jan 2026). Preparing global registrational programme for absence seizures and DEE. Phase 2 in Prader-Willi syndrome planned Q1 2026. View profile context | Phase II Programme phase | Bright Minds Biosciences Pipeline company-website · Bright Minds Biosciences · Jun 27, 2026 · Verified | 4 sources 0 trials · 0 papers Phase III started Eventual approval estimate: 45% | |
SYNP-101 Phase 2 Programme (OCD) SYNP-101 has FDA IND clearance for a Phase 2 OCD trial and a related Frontiers in Psychiatry/Yale publication dated 2025-12-10. No public Phase 3 start, partnership, or sponsor status-changing update was found in the June 2026 sweep; keep as waiting-on-news pending new Ceruvia/Yale/B.More evidence. View profile context | Phase II Programme phase | SSRN preprint for psilocybin OCD study Publication · SSRN · Jan 1, 2026 · plausible | 6 sources 0 trials · 0 papers Phase III started | |
SYNP-101 Phase 2b Programme (Alcohol Use Disorder) Phase 2b in planning; builds on Bogenschutz/NYU psilocybin AUD Phase 2a evidence View profile context | Phase II Programme phase | SSRN preprint for psilocybin OCD study Publication · SSRN · Jan 1, 2026 · plausible | 5 sources 0 trials · 0 papers Forecast saved | |
Psilocybin Phase IIb Programme (AUD, EU + Canada) Phase IIb (CLA-PSY-201) enrollment and treatment completed; 154 subjects randomized across 12 sites in EU + Canada; topline data anticipated but repeatedly delayed (originally mid-2023, then Q3 2024, then early 2025) View profile context | Phase II Programme phase | ClinicalTrials.gov NCT05646303 current registry snapshot for Clairvoyant AUD psilocybin Phase 2b Registry update · ClinicalTrials.gov · Jun 26, 2026 · Verified | 11 sources 0 trials · 0 papers Forecast saved | |
CLE-100 Phase 2 Programme (MDD) SOLEO Phase 2 (NCT06340958) is completed on ClinicalTrials.gov. The registry lists 99 actual participants, actual primary completion in June 2025, actual study completion in November 2025, and a last update posted on 2026-06-23. No public topline results release was found in this pass. View profile context | Phase II Programme phase | ClinicalTrials.gov NCT06340958 - SOLEO Phase 2 CLE-100 MDD Study Registry update · ClinicalTrials.gov · Jun 23, 2026 · Verified Milestone: Phase II started · actual Jun 1, 2024 | 2 sources 0 trials · 0 papers Phase II topline · likely Q3 2026 | |
COMP360 PTSD FDA accepted the PTSD IND in January 2026; late-stage Redefine study (COMP202) planned. View profile context | Phase II Programme phase | Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD Press release · Compass Pathways · Jan 7, 2026 · Verified Milestone: Phase III planned | 3 sources 7 trials · 0 papers No forecast saved | |
ASD Phase 2a Phase 2a ASD study NCT07303907 is recruiting. ClinicalTrials.gov lists 20 estimated participants, actual start on 2025-12-03, last update posted 2026-04-06, and primary completion expected August 2027; the prior 2026 topline expectation should be treated as superseded by the registry timeline. View profile context | Phase II Programme phase | ClinicalTrials.gov NCT07303907 - DT402 Phase 2a ASD study clinical-trial-registry · ClinicalTrials.gov · Apr 6, 2026 · Verified Milestone: Phase II started · actual Oct 1, 2025 | 6 sources 1 trials · 0 papers Phase II topline · likely Q4 2027 Eventual approval estimate: 10% | |
Zalsupindole Phase 2 Programme (MDD, at-home) FDA has cleared Delix's randomized, double-blind, placebo-controlled Phase 2 design for DLX-001 in MDD, including at-home self-administration. The next public watch item is Phase 2 first-patient-in or trial registration. View profile context | Phase II Programme phase | Cumulus/Delix ASCP 2026 poster update for zalsupindole Phase 1b and upcoming Phase 2 Press release · Cumulus Neuroscience / PR Newswire · May 28, 2026 · Verified Milestone: Phase I topline · actual Dec 12, 2024 | 9 sources 0 trials · 0 papers Phase II started · likely Q4 2026 | |
Low-Dose Psilocybin Phase 2a Programme (Demoralization, UAB) Phase 2a ongoing at UAB (NCT06341426); 60 patients; 5-week randomised double-blind; PI: Dr. Peter Hendricks View profile context | Phase II Programme phase | Diamond Therapeutics - Company and News company-website · Diamond Therapeutics · Jun 26, 2026 · Verified | 7 sources 0 trials · 0 papers Phase II topline | |
Low-Dose Psilocybin Phase 2a Programme (GAD, Health Canada) Phase 2a ongoing at Kingston Health Sciences Centre (KHSC), Ontario; first-ever Health Canada-approved at-home microdose psychedelic trial; first patient July 30, 2025 View profile context | Phase II Programme phase | Diamond Therapeutics - Company and News company-website · Diamond Therapeutics · Jun 26, 2026 · Verified | 10 sources 0 trials · 0 papers Phase II topline | |
EMDMA-001 Phase 2 Open-Label (PTSD, TGA Authorised) Open-label 12-month MDMA-AT study at PAX Centre Perth; MDMA supply for up to 70 patients secured; national expansion underway View profile context | Phase II Programme phase | ANZCTR ACTRN12623000838617 - MDMA-Assisted Therapy for PTSD Registry update · ANZCTR · Jun 27, 2026 · Verified Milestone: Regulatory review accepted · actual Jul 1, 2023 | 7 sources 0 trials · 0 papers Phase II topline | |
TRP-8802 Phase 2a Programme (Binge Eating Disorder) TRP-8802 oral psilocybin Phase 2a studies in BED and fibromyalgia are complete. Entropy reported peer-reviewed BED results on 2026-01-13 showing sustained binge-eating reductions through 14 weeks, and is using the TRP-8802 oral psilocybin data package to support the lead TRP-8803 IV psilocin programme. View profile context | Phase II Programme phase | TRP-8802 Phase 2a BED results ASX announcement Press release · Entropy Neurodynamics / ASX · Jan 13, 2026 · Verified Milestone: Phase II topline · actual Aug 1, 2022 | 5 sources 0 trials · 0 papers Phase II started · likely Q4 2026 | |
TRP-8803 Phase 2 Programme (BED, World-First IV Psilocin) World's first clinical study of IV-infused psilocin; first patient dosed December 2025 at Swinburne University Melbourne; Cohort 1 complete, Cohort 2 enrolling View profile context | Phase II Programme phase | DSMB Clears TRP-8803 to Advance to Cohort 2 Press release · Entropy Neurodynamics / ASX · Jun 16, 2026 · Verified | 4 sources 0 trials · 0 papers Phase II topline | |
PEX010 — Phase 2 Alcohol Use Disorder Phase 2 POSITIVE DATA announced March 2025. Study at Psychiatric Centre Copenhagen (completed) and University of Washington. Additional Phase 2 for PTSD+AUD in veterans/first responders authorized by FDA July 2025 at University of Washington, funded by State of Washington. View profile context | Phase II Programme phase | Filament Health — Drug Development company-website · Filament Health · Jun 27, 2026 · Verified | 6 sources 0 trials · 0 papers Phase II topline | |
PEX010 — Phase 2 Brain Function & Wellbeing (UCL) Two Phase 2 trials in partnership with University College London, MHRA approved (July 2025). Investigating effects on brain function, perception, and psychological well-being. View profile context | Phase II Programme phase | Filament Health — Drug Development company-website · Filament Health · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Phase II topline | |
PEX010 — Phase 2 Methamphetamine Use Disorder (UBC) Phase 2 authorized at University of British Columbia for methamphetamine use disorder (MAUD). Health Canada regulatory pathway. View profile context | Phase II Programme phase | Filament Health — Drug Development company-website · Filament Health · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Phase II topline | |
PEX010 — Phase 2 Opioid Use Disorder (UPenn) FDA authorized Phase 2 clinical trial at University of Pennsylvania (April 2025). Funded by Wellcome Leap. Studying psilocybin-assisted therapy for opioid use disorder. View profile context | Phase II Programme phase | Filament Health — Drug Development company-website · Filament Health · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Phase II topline | |
FREE001-TRD-201 Phase 2a (TRD) — FDA IND Phase 2a dose-ranging trial underway (~100 patients) since H1 2024. FDA IND approved April 2024. Data readout expected ~2026. Yale spinout co-founded by Dr. John Krystal (Chair of Psychiatry, Yale). Total funding ~$10.5M. View profile context | Phase II Programme phase | Freedom Biosciences - Pipeline company-website · Freedom Biosciences · Jun 26, 2026 · Verified Milestone: Phase II started · actual Jun 1, 2024 | 7 sources 0 trials · 0 papers Phase II topline | |
GH001 Bipolar II — Phase 2a POC BDII-specific development remains quiet: the NCT05839509 registry is terminated and no follow-on BDII study was found. GH001 as a parent programme is advancing in TRD after FDA lifted the U.S. clinical hold on 2026-01-05 and the Phase 2b TRD results were published in JAMA Psychiatry on 2026-03-25, with global pivotal initiation targeted for 2026. View profile context | Phase II Programme phase | GH Research - Pipeline company-website · GH Research · Jun 26, 2026 · Verified | 8 sources 1 trials · 0 papers No forecast saved | |
GH001 PPD — Phase 2a POC Phase 2a completed Q4 2024. All 10 patients in remission — striking result. No further PPD development announced; resources focused on TRD Phase 3. View profile context | Phase II Programme phase | GH Research - Pipeline company-website · GH Research · Jun 26, 2026 · Verified | 8 sources 1 trials · 0 papers No forecast saved | |
Blixeprodil Phase 2 Programme (MDD) Phase 2a complete (positive topline January 2026); late-stage Phase 2b/3 planning underway for 2026 View profile context | Phase II Programme phase | Gilgamesh announces positive Phase 2a topline results for blixeprodil (GM-1020) in MDD Press release · Gilgamesh Pharma / PR Newswire · Jan 6, 2026 · Verified Milestone: Phase II started · actual May 1, 2024 | 5 sources 0 trials · 0 papers Phase II started · likely Q4 2026 | |
HLP004 GAD — Phase 2 POC Helus announced positive Phase 2 signal-detection topline results for HLP004 in GAD on 2026-03-05. The 20 mg adjunctive arm showed a 10.4-point mean HAM-A reduction at six weeks, with pooled six-month response/remission rates of 67%/39%. Next watch items are durability follow-up, a peer-reviewed publication, or Phase 3 guidance. View profile context | Phase II Programme phase | Helus announces HLP004 Phase 2 signal-detection topline results in GAD Press release · Helus Pharma / GlobeNewswire · Mar 5, 2026 · Verified Milestone: Phase II topline · actual Mar 5, 2026 | 4 sources 0 trials · 0 papers Phase III planned · likely Q1 2027 Eventual approval estimate: 20% | |
PSX-001 PsiGAD Phase 2 → Phase 2b (GAD) — NCT05942911 Phase 2 PsiGAD1 complete with positive results (73 patients). Preparing multi-jurisdiction Phase 2b. Open IND with FDA. Clinical Advisory Board formed. Well-funded: $70M+ cash, runway into 2027. Nasdaq:IXHL / ASX:IHL. View profile context | Phase II Programme phase | ANZCTR ACTRN12621001358831 - Psi-GAD-1 Registry update · ANZCTR · Jun 27, 2026 · Verified | 9 sources 0 trials · 0 papers Phase II topline | |
KET01 Programme (TRD) — oral prolonged-release ketamine Phase 2 (KET01-02) completed; Phase 3 pivotal trial planned (enrollment not yet confirmed); head-to-head vs Spravato data published View profile context | Phase II Programme phase | Ketabon - KET01 Programme company-website · Ketabon · Jun 26, 2026 · Verified Milestone: phase-2-results · actual Aug 14, 2023 | 8 sources 0 trials · 0 papers Forecast saved | |
MB22001 Phase 2B Cancer Distress (ACTRN12623000478617) Phase 2B in 40 advanced-stage cancer patients ongoing. Existential distress, depression, anxiety in cancer as indication. View profile context | Phase II Programme phase | MindBio Therapeutics - Current Website company-website · MindBio Therapeutics · Jun 26, 2026 · Verified | 6 sources 0 trials · 0 papers Forecast saved | |
MB22001 Phase 2B MDD Programme (ACTRN12624000128594) Phase 2B MDD completed in November 2025 and did not show superiority for repeated microdosed LSD over active placebo on MADRS at week 8. MindBio reported 29.9% MADRS reduction in the LSD arm versus 36.4% in placebo/caffeine (p=0.5469), with favorable tolerability and no serious adverse events in the LSD arm. The next watch item is whether MindBio publishes the dataset or redirects MB22001 development toward cancer distress/PMDD rather than MDD. View profile context | Phase II Programme phase | MindBio Therapeutics - Current Website company-website · MindBio Therapeutics · Jun 26, 2026 · Verified Milestone: Phase II topline · actual Nov 13, 2025 | 12 sources 0 trials · 0 papers Phase II publication · likely Q4 2026 | |
MSP-1014 Phase 2 Programme (MDD) — acquired by Otsuka MHRA-approved Phase 2 trial (NCT05624268) for MDD with ACT psychotherapy; may be deprioritized in favor of MSP-2020 View profile context | Phase II Programme phase | Otsuka Pharmaceutical to Acquire Mindset Pharma Press release · Newsfile / Otsuka and Mindset · Aug 31, 2023 · Verified Milestone: Licensing deal · actual Sep 1, 2023 | 4 sources 0 trials · 0 papers Phase II topline | |
MSX-06 Phase 2 Programme (TRD/OCD — Israel) Israeli Ministry of Health approved clinical trial for OCD and depression; Phase 2 recruiting; PTSD study call for proposals in review; GMP production facility operational in Ness Ziona View profile context | Phase II Programme phase | MSICS Pharma - MSX-06 company-website · MSICS Pharma · Jun 26, 2026 · Verified Milestone: Company milestone · actual Jan 1, 2022 | 8 sources 0 trials · 0 papers Forecast saved | |
MYCO-001 Phase 2a Programme (PTSD, Veterans) Phase 2a in veteran PTSD; partnership with Combat Stress (UK) and King's College London; PI: Dr. Rakesh Jetly View profile context | Phase II Programme phase | Psychedelic Alpha - Psychedelic Drug Development Tracker industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Phase II topline | |
MYCO-001 Phase 2b Programme (Smoking Cessation) Phase 2b multi-site placebo-controlled trial; PI: Dr. Matthew Johnson (Johns Hopkins); sites: Hopkins, NYU, UAB; IND filed with FDA View profile context | Phase II Programme phase | Psychedelic Alpha - Psychedelic Drug Development Tracker industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Phase II topline | |
NRCx-201 Phase 2 Programme (Bipolar Depression / TRD) — Wellcome Trust Funded Wellcome-backed Phase 2 bipolar-depression study NCT07644767 is registered but not yet recruiting. The registry lists 160 estimated participants, estimated start on 2026-10-30, primary completion in January 2028, and last update posted 2026-06-12. The September 2025 Wellcome funding release remains the key financing source. View profile context | Phase II Programme phase | Neurocentrx - NRCx-201 Product Page company-website · Neurocentrx · Jun 26, 2026 · Verified Milestone: Phase II started · actual Jan 1, 2026 | 11 sources 0 trials · 0 papers Phase II started · likely Q4 2026 | |
MSP-1014 Adaptive Phase 2a/2b (MDD, SSRI Non-Responders) — MHRA/UK Adaptive Phase 2a/2b at Clerkenwell Health, UK (~70 patients). Part 1: open-label dose escalation 30/50/70mg (n~10). Part 2: double-blind RCT vs placebo (n~60). MHRA approved June 2023. Data readout not yet reported (study period reportedly ended Oct 2024). View profile context | Phase II Programme phase | Psychedelic Alpha tracker lists Otsuka MSP-1014 for MDD as Phase 2 industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified | 5 sources 0 trials · 0 papers Phase II topline | |
Ketamine Phase 2 Programme (Parkinson's / LID) — NCT04912115 Phase 2 complete (suspended before planned March 2024 completion); positive results — subanesthetic IV ketamine reduced LID; advancing toward Phase 3, seeking partnership View profile context | Phase II Programme phase | PharmaTher CEO shareholder letter notes continued evaluation of internal ketamine programs in 2026 Press release · PharmaTher · Jan 1, 2026 · Verified | 7 sources 0 trials · 0 papers Phase II topline | |
NPX-5 Phase IIb Programme (Adjustment Disorder, Palliative Care) — ANZCTR 12624000449538p Phase IIb active in Australia (TGA); 87 participants; 3 sites operational (Perth, Melbourne ×2); patient dosing underway; GMP NPX-5 exported from Canada to Australia confirmed March 2026; topline results expected end of 2026 View profile context | Phase II Programme phase | Psyence BioMed Initiates Patient Dosing in Phase IIb NPX-5 Trial Regulatory filing · SEC / Psyence BioMed · Apr 23, 2026 · Verified Milestone: Trial start · actual Jan 1, 2025 | 6 sources 0 trials · 0 papers Phase II topline | |
RE03 — Phase 2a Insomnia in PTSD (NCT06685965) RE03 Phase 2a is recruiting in PTSD-related sleep disturbance. Reconnect announced first patient enrollment on 2025-10-20, and ClinicalTrials.gov lists estimated study completion in August 2026. View profile context | Phase II Programme phase | Reconnect Labs - Clinical Pipeline company-website · Reconnect Labs · Jun 26, 2026 · Verified Milestone: Trial start · actual Jun 1, 2025 | 8 sources 0 trials · 0 papers Phase II topline · likely Q4 2026 | |
RSTP1000 Phase 2b Programme (Demoralization in Cancer) FDA IND cleared November 2023 ("Safe to Proceed"); Phase 2b multicenter, randomized, dose-ranging, double-blind, parallel-group study; likely in site activation/early enrollment; quiet since IND clearance View profile context | Phase II Programme phase | Reset Pharma focus page identifies proprietary RSTP-1000 for demoralization syndrome company-website · Reset Pharma · Jun 26, 2026 · Verified Milestone: Funding milestone · actual Jun 1, 2022 | 7 sources 0 trials · 0 papers Phase II topline | |
RECLAIM — RE104 GAD Phase 2 RECLAIM Phase 2 is recruiting for generalized anxiety disorder. ClinicalTrials.gov lists an actual study start in April 2026 and an estimated primary completion in February 2027; Reunion expects clinical data in Q2 2027. View profile context | Phase II Programme phase | ClinicalTrials.gov NCT07489651 - RE104 in Generalized Anxiety Disorder clinical-trial-registry · ClinicalTrials.gov · Jun 26, 2026 · Verified Milestone: Phase II started | 5 sources 0 trials · 0 papers Phase II topline · likely Q2 2027 | |
REKINDLE — RE104 Adjustment Disorder Phase 2 REKINDLE Phase 2 is recruiting in adjustment disorder related to cancer and other medical illnesses. ClinicalTrials.gov lists estimated primary completion in November 2026, and Reunion has guided to topline results in 2027. View profile context | Phase II Programme phase | NCT07002034 — REKINDLE Phase 2 (RE104 Adjustment Disorder) clinical-trial-registry · ClinicalTrials.gov · Jun 3, 2026 · Verified | 2 sources 0 trials · 0 papers Phase II topline · likely Q1 2027 | |
GlyphAllo BUOY-1 Phase 2b Programme (MDD) BUOY-1 Phase 2b enrolling (NCT07065240); ~360 participants; 6-week HAMD-17 primary endpoint View profile context | Phase II Programme phase | Seaport Reports Q1 2026 Results and BUOY-1 Enrollment Progress Press release · BioSpace / Seaport Therapeutics · Jun 12, 2026 · Verified | 7 sources 0 trials · 0 papers Phase II topline | |
SVN-002 Phase 2b Programme (AUD, US 505(b)(2)) Solvonis reported positive SVN-002 PK bridging data on 2026-06-22. Next steps are FDA feedback on toxicology/CMC, then IND submission to start a US Phase 2b AUD study under a planned 505(b)(2) pathway referencing Spravato. View profile context | Phase II Programme phase | Solvonis SVN-002 page notes positive FDA pre-IND meeting and 505(b)(2) support company-website · Solvonis Therapeutics · Jun 27, 2026 · Verified Milestone: Regulatory review accepted · actual Dec 1, 2024 | 7 sources 0 trials · 0 papers Phase II started · likely Q4 2026 Eventual approval estimate: 25% | |
CMND-100 Phase I/IIa Programme (AUD) — Yale/JHU/Tel Aviv Phase I/IIa multinational trial active; Cohorts 1 and 2 completed (12 patients, no SAEs); Cohort 3 recruiting at 80mg dose escalation (Yale, JHU, Tel Aviv Sourasky); DSMB cleared dose escalation March 2026 View profile context | Phase I/II Programme phase | Clearmind Completes Dosing for Part A of FDA-Regulated Phase I/II Trial Press release · Clearmind Medicine · Jun 16, 2026 · Verified Milestone: Efficacy data · actual Nov 24, 2025 | 15 sources 0 trials · 0 papers Forecast saved | |
AP-188 Programme (Stroke/TBI) — Algernon NeuroScience subsidiary Phase 1 DMT study NCT05559931 is registry-listed as active, not recruiting, with last update posted 2025-01-28 and estimated completion in March 2026. PubMed-indexed 2025 Phase 1 publication supports safety/PK/PD for the 6-hour IV infusion. No public source found confirming Phase 2 stroke/TBI start as of the June 2026 sweep; corporate news indicates the programme now sits inside a Grey Matters/NovaScan diagnostics pivot. View profile context | Phase I Programme phase | Algernon NeuroScience Pipeline Overview company-website · Algernon NeuroScience · Jun 27, 2026 · Verified | 13 sources 0 trials · 0 papers Forecast saved | |
AM-1002 — Phase 1 First-in-Human (GAD) FDA IND cleared October 6, 2025. Phase 1 first-in-human trial planned. No NCT number posted or first-patient-dosed announcement as of April 2026. Gary Riordan (former FDA primary reviewer) leads regulatory. View profile context | Phase I Programme phase | What is Sam Altman's involvement in MDMA developer Arcadia? industry-media · Psychedelic Health · Oct 15, 2025 · Verified Milestone: regulatory-milestone · actual Oct 6, 2025 | 8 sources 0 trials · 0 papers Phase I topline | |
NYPRG-101 Phase 1 Programme (Migraine Prevention) IND submitted for NYPRG-101 migraine prevention in June 2022 and first participant dosed in Phase 1 in January 2023; no newer public trial registry or company status update found in this pass. View profile context | Phase I Programme phase | Ceruvia Research - BOL-148 / NYPRG-101 company-website · Ceruvia Lifesciences · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers programme-status-update | |
CLE-905 Phase 1 Programme (Schizophrenia) — Syremis spinout Licensed/spun out to Syremis Therapeutics. Fierce Biotech reported Syremis launched on 2025-12-18 with a $165M Series A and ST-905/CLE-905 in Phase 1 development for schizophrenia and other neuropsychiatric conditions; Syremis also lists ST-905 as a potent M1/M4 preferential muscarinic agonist. View profile context | Phase I Programme phase | Syremis launches with $165M Series A to advance ST-905/CLE-905 News / media · Fierce Biotech · Dec 18, 2025 · Verified Milestone: Licensing deal · actual Jun 1, 2024 | 3 sources 0 trials · 0 papers Phase I topline · likely Q4 2026 | |
DMX-1001 Programme (AUD) — Neuroplastogen / GDNF Enhancer Phase 1 MAD trial completed in 55 healthy volunteers (NCT06480981), with January 2026 safety/tolerability/PK results supporting Phase 2 development. FDA accepted the DMX-1001 IND for AUD in April 2026; DemeRx says an alcohol-interaction trial will support Phase 2 start in 2027. View profile context | Phase I Programme phase | NIH RePORTER Project 11061564 - Noribogaine for AUD grant-database · NIH RePORTER · Jun 27, 2026 · Verified | 8 sources 0 trials · 0 papers Forecast saved | |
GH002 — Phase 1 Healthy Volunteers GH002 Phase 1 healthy-volunteer study is complete. GH Research clinical-trials materials describe the IV mebufotenin study as n=64 with no severe or serious adverse events, and the FY2025 update continues to list GH002 as an IV mebufotenin product candidate. No patient-indication next step has been publicly announced. View profile context | Phase I Programme phase | GH Research — Clinical Trials Overview company-website · GH Research · Jun 27, 2026 · Verified | 4 sources 1 trials · 0 papers No forecast saved | |
L-130 Programme (Cluster Headache / OUD) — via Cynaptec Pharmaceuticals Phase 1 NCT06035900 is completed and a 2024 publication reports first-in-human pharmacokinetic data. Lobe reported on 2026-05-06 that R&D spend increased primarily from advancement of Cynaptec Pharmaceuticals L-130 work; no public Phase 2 start was found in this pass. View profile context | Phase I Programme phase | Lobe Sciences Q2 2026 update notes continued L-130 advancement Press release · Lobe Sciences / ACCESS Newswire · May 6, 2026 · Verified Milestone: Company milestone · actual Sep 9, 2025 | 15 sources 0 trials · 0 papers Phase II started · likely Q1 2027 | |
LPH-5 Phase I Programme (TRD/MDD) — EMA-authorised Lophora dosed first subjects in Phase 1 in May 2025 and reported positive Phase 1 topline results for LPH-5 on June 10, 2026; the company now describes LPH-5 as entering Phase Ib. View profile context | Phase I Programme phase | Lophora Announces Positive Phase 1 Topline Results for LPH-5 Press release · Lophora · Jun 10, 2026 · Verified | 9 sources 0 trials · 0 papers Phase II started | |
MSP-2020 Phase 1 Programme (MDD) — Otsuka lead neuroplastogen MSP-2020 is listed in Otsuka's Mar. 31, 2026 pipeline as an oral Phase I psychiatry/neurology programme. A recruiting Phase 1 PET/brain-imaging study, NCT07329621, began in January 2026. View profile context | Phase I Programme phase | ClinicalTrials.gov NCT07329621 - MSP-2020 5-HT2A PET Binding Study clinical-trial-registry · ClinicalTrials.gov · Jun 12, 2026 · Verified | 5 sources 0 trials · 0 papers Forecast saved | |
MSD-001 Phase 1 Programme (Mood/Anxiety) — CHDR Netherlands MSD-001 Phase 1 SAD study NCT06702332 is completed. Mindstate announced topline results on 2025-09-24: MSD-001 was safe and well tolerated, showed dose-proportional linear PK, produced narrowly defined psychoactive effects without hallucinations, and will primarily serve as a base compound for fixed-dose combinations. The next watch item is initiation or registration of a fixed-dose combination Phase 1 study. View profile context | Phase I Programme phase | Mindstate Design Labs Pipeline - MSD-001 company-website · Mindstate Design Labs · Jun 26, 2026 · Verified Milestone: Funding milestone · actual Feb 1, 2022 | 10 sources 0 trials · 0 papers Phase I started · likely Q1 2027 | |
MLS101 Phase 1 Programme (SAD/MAD/Neuroimaging) — Australia Three MLS101 Phase 1 studies are completed on ClinicalTrials.gov, including the fMRI/translational study NCT07050368 with actual completion on 2026-01-13 and last update posted 2026-02-13. No public Phase 1 data package or Phase 2 start was found in this pass. View profile context | Phase I Programme phase | MycoMedica Programs - Low-Dose Psilocybin Trials company-website · MycoMedica Life Sciences · Jun 27, 2026 · Verified | 11 sources 0 trials · 0 papers Phase I publication · likely Q4 2026 | |
NBX-100 (1st gen) — Phase 1 PoC (St Vincent's Melbourne) Completed. Phase 1 proof-of-concept with first-generation DMT-harmala formulation. Results published in Scientific Reports (Nature Portfolio) early 2025. View profile context | Phase I Programme phase | Neurala Biosciences — Official Website company-website · Neurala Biosciences · Jun 27, 2026 · Verified | 6 sources 0 trials · 0 papers No forecast saved | |
NBX-100 (2nd gen) — Phase 1 PK/PD (CMAX Adelaide) HREC and TGA regulatory approvals granted. GMP drug product final release testing completed Jan 2026. All clinical and CRO contracts in place. Phase 1 PK/PD study at CMAX Clinical Research (Adelaide) commencing. Second-generation formulation with proprietary harmala alkaloid refinements. View profile context | Phase I Programme phase | Neurala Biosciences — Official Website company-website · Neurala Biosciences · Jun 27, 2026 · Verified | 7 sources 0 trials · 0 papers Phase II started | |
RE01 — Phase 1 Safety & PK (Cocaine/Stimulant SUD) Phase 1 studies NCT04716335 and NCT05829603 are complete, with peer-reviewed DMT/harmine formulation data published. Reconnect still lists RE01 for cocaine and stimulant use disorder, and a March 2026 company release highlighted RE01 as a controllable, scalable psychedelic architecture. View profile context | Phase I Programme phase | Reconnect Labs Clinical Pipeline company-website · Reconnect Labs · Jun 27, 2026 · Verified | 8 sources 0 trials · 0 papers Phase II started · likely Q1 2027 | |
RE02 — Phase 1 (Treatment-Resistant GAD) The Phase 1 RE02 registry remains listed as terminated after 4 participants. Reconnect's current pipeline still describes RE02 as a rapid-acting, non-addictive anxiolytic for treatment-resistant GAD, so the next action is company clarification of Phase 1 outcome and Phase 2a timing. View profile context | Phase I Programme phase | Reconnect Labs Clinical Pipeline company-website · Reconnect Labs · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Phase II started · likely Q2 2027 | |
Whole Mushroom Psilocybin Phase 1/2 PTSD (NCT07275970) — FDA Authorized Recruiting Phase 1 trial NCT07275970 is listed with a February 2026 start for whole psilocybin-containing mushrooms in adults with PTSD. Recent reporting says Arizona funding and first-responder interest are supporting the study. View profile context | Phase I Programme phase | First Responders with PTSD Are Turning to Arizona Psilocybin Trial news · InvestigateTV · Apr 24, 2026 · Verified Milestone: Phase I started · actual Dec 1, 2025 | 8 sources 0 trials · 0 papers Phase I topline | |
GlyphAgo Phase 1 Programme (GAD/MDD) Phase 1 GlyphAgo/SPT-320 trial has positive SAD, crossover, and MAD data reported through June 2026. Seaport plans a Phase 2a GAD trial in H2 2026 and a Phase 2b GAD trial in H1 2027. View profile context | Phase I Programme phase | ANZCTR 389549 - Phase 1 Single and Multiple Ascending Dose Trial of SPT-320 clinical-trial-registry · ANZCTR · Jun 26, 2026 · Verified Milestone: Phase I started · actual Sep 1, 2025 | 9 sources 0 trials · 0 papers Phase II started | |
Idazoxan XR — Phase 1 PK/Safety (NCT05727189) Idazoxan XR Phase 1 study NCT05727189 is active, not recruiting. ClinicalTrials.gov lists 150 estimated participants, multiple extended-release idazoxan formulations, and estimated primary/completion dates in December 2027. View profile context | Phase I Programme phase | Terran Biosciences Pipeline - Idazoxan XR company-website · Terran Biosciences · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Phase I completed · likely Q4 2027 | |
SAI NCE — IND-Enabling Ophthalmology Nerve Regeneration IND-enabling studies underway (as of August 2025). Human clinical trials targeted for November 2026. Preclinical programme demonstrated corneal nerve regeneration, RGC protection in glaucoma, and resolution of ocular inflammation in animal models. View profile context | Preclinical Programme phase | 2A Biosciences — Pipeline & Milestones (Pitch.vc) industry-media · Pitch.vc · Jun 27, 2026 · Verified Milestone: data-readout · actual Nov 1, 2024 | 6 sources 0 trials · 0 papers Forecast saved | |
GM-5022 / AbbVie-Partnered Neuroplastogens - Depression & Anxiety Preclinical AbbVie-partnered neuroplastogen programme. AbbVie/Gilgamesh collaboration remains active after AbbVie acquired only bretisilocin; Gilgamesh now presents the class as non-hallucinogenic Neuroplastogens for depression and anxiety. View profile context | Preclinical Programme phase | Gilgamesh Pharma - Pipeline company-website · Gilgamesh Pharma · Jun 26, 2026 · Verified | 6 sources 0 trials · 0 papers Preclinical completed | |
ASR-2001 Preclinical Programme Indication unknownUS (FDA)Active Preclinical phenylalkylamine work remains supported by ASRI 2024 patent filings and news updates; no clinical trial registration was found in this pass. View profile context | Preclinical Programme phase | ASRI Latest News - Phenylalkylamine Programme company-website · Alexander Shulgin Research Institute · Jun 26, 2026 · Verified | 2 sources 0 trials · 0 papers preclinical-data | |
ASR-3001 IND-Enabling Programme (Depression/Anxiety) ASRI continues to describe ASR-3001 as its advanced tryptamine candidate, supported by 2024 patent filings. No public IND filing was found in this pass. View profile context | Preclinical Programme phase | ASRI latest-news archive notes $7.2M seed financing round company-website · Alexander Shulgin Research Institute · Jun 27, 2026 · Verified Milestone: Funding milestone · actual Dec 9, 2021 | 9 sources 0 trials · 0 papers Regulatory filing submitted | |
5-MeO-DMT Preclinical Programme (SUD) — UCD Dublin collaboration Alvarius still presents a 5-MeO-DMT substance-use programme and planned Phase 1 safety work on its website, but no public clinical trial registration or Phase 1 start confirmation was found in this pass. View profile context | Preclinical Programme phase | Alvarius Pharmaceuticals - 5-MeO-DMT Programme company-website · Alvarius Pharmaceuticals · Jun 26, 2026 · Verified Milestone: preclinical-data · actual Jun 1, 2023 | 9 sources 0 trials · 0 papers Forecast saved | |
AM-1004 — Preclinical MDD Preclinical/discovery. Arcadia lists AM-1004 for MDD as a short-acting psychoactive-empathogen combination therapy; no IND or clinical trial has been announced as of June 2026. View profile context | Preclinical Programme phase | Arcadia Medicine — Pipeline company-website · Arcadia Medicine · Jun 26, 2026 · Verified Milestone: Preclinical started · actual Oct 6, 2025 | 4 sources 0 trials · 0 papers Preclinical completed | |
AM-1006 — Preclinical SUD Preclinical/discovery. Arcadia lists AM-1006 for substance use disorder/substance abuse as a short-acting subperceptual psychoactive drug intended for hour-long therapeutic settings. View profile context | Preclinical Programme phase | Arcadia Medicine — Pipeline company-website · Arcadia Medicine · Jun 26, 2026 · Verified Milestone: Preclinical started · actual Oct 6, 2025 | 4 sources 0 trials · 0 papers Preclinical completed | |
BETR-001 IND-Enabling Programme (MDD/Anxiety/Cluster Headache) BETR-001 remains in final IND-enabling development. BetterLife closed CAD $2M financing on 2026-06-22 to fund remaining FDA IND work, then engaged Syner-G on 2026-06-25 to oversee GMP manufacturing for the planned IND and Phase 1 programme. The initial clinical focus has shifted to chronic cluster headache and chronic migraine, with IND filing and Phase 1 start projected for Q1 2027. View profile context | Preclinical Programme phase | BetterLife engages Syner-G for BETR-001 GMP manufacturing toward IND and Phase 1 Press release · BetterLife Pharma / Newsfile · Jun 25, 2026 · Verified Milestone: Company milestone · actual Jan 1, 2025 | 10 sources 0 trials · 0 papers Regulatory filing submitted · likely Q1 2027 | |
BMND06 Preclinical Programme (Obesity via Neurological Pathway) BMND06 remains publicly positioned for obesity through neurological pathways, based on Biomind's July 2024 update and current company pipeline language. View profile context | Preclinical Programme phase | Biomind Labs Pharma Pipeline company-website · Biomind Labs · Jun 26, 2026 · Verified Milestone: Preclinical completed · actual Jul 1, 2024 | 4 sources 0 trials · 0 papers preclinical-data | |
BMB-201 — Headache/Pain Preclinical Positive preclinical pain and vascular-headache data support advancement toward clinical development. No IND filing or human-study start was found in the June 2026 sweep, so the next watch item remains additional preclinical/IND-enabling disclosure or a clinical-trial start announcement. View profile context | Preclinical Programme phase | Bright Minds Biosciences Pipeline company-website · Bright Minds Biosciences · Jun 26, 2026 · Verified | 2 sources 0 trials · 0 papers preclinical-data | |
BMB-202 — Preclinical Depression Preclinical 5-HT2A agonist for depression. Bright Minds’ recent communications emphasize BMB-101 and BMB-201; no clinical-stage BMB-202 update was found in June 2026 checks. View profile context | Preclinical Programme phase | Psychedelic Alpha — Psychedelic Drug Development Tracker industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified | 3 sources 0 trials · 0 papers Preclinical completed | |
CT-4201 IND-Enabling Programme (MDD) CT-4201 remains preclinical/IND-enabling; CaaMTech reported FDA feedback in November 2024 validating its functional-unblinding strategy for future MDD trials. View profile context | Preclinical Programme phase | CaaMTech Press Archive company-website · CaaMTech · Jun 26, 2026 · Verified Milestone: Company milestone · actual Apr 22, 2025 | 9 sources 0 trials · 0 papers Phase I started | |
DLX-159 Preclinical Programme DLX-159 remains a preclinical Delix developmental candidate; Delix presented preclinical findings at ACNP 2024 and described it as orally bioavailable and non-hallucinogenic. View profile context | Preclinical Programme phase | Delix Therapeutics Company Site company-website · Delix Therapeutics · Jun 26, 2026 · Verified | 2 sources 0 trials · 0 papers preclinical-data | |
MDMA Analogue Library Preclinical Programme (UWA, 150+ compounds) UWA/Emyria MDMA-analogue programme remains preclinical, with UWA 2025 award coverage confirming Emyria rights to the analogue library and initial Parkinson disease focus. View profile context | Preclinical Programme phase | UWA Research Recognised in Innovator of the Year Awards university-news · University of Western Australia · Nov 1, 2025 · Verified | 2 sources 0 trials · 0 papers Forecast saved | |
EB-003 IND-Enabling Programme (PTSD/MDD) EB-003 remains in 2026 IND preparation after Enveric completed dose-range studies and received FDA pre-IND feedback in 2025; first-in-human Phase 1 planning continues. View profile context | Preclinical Programme phase | Untitled source Press release · BioSpace · Mar 30, 2026 · Verified Milestone: Company milestone · actual Sep 2, 2025 | 14 sources 0 trials · 0 papers Forecast saved | |
EQL-101 — IND-Enabling Studies (OUD/SUD) IND-enabling studies underway. First-in-human dosing targeted for Q4 2026. NIDA-funded preclinical work at RTI International confirms anti-addictive efficacy comparable to ibogaine in animal models. Transdiagnostic regulatory strategy targeting multiple indications. View profile context | Preclinical Programme phase | How Analog Ibogaine Could Help Conquer CNS Disorders — Drug Discovery Online industry-media · Drug Discovery Online · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Regulatory filing submitted | |
GM-3009 IND-Enabling Programme (OUD/PTSD/TBI) GM-3009 remains an active preclinical/IND-enabling ibogaine-analogue programme supported by the 14M NIDA grant; Gilgamesh reported in 2026 that Phase 1 entry is expected later this year. View profile context | Preclinical Programme phase | Gilgamesh Pharma Pipeline - GM-3009 company-website · Gilgamesh Pharma · Jun 27, 2026 · Verified | 5 sources 0 trials · 0 papers Forecast saved | |
GM-5022 Preclinical Programme GM-5022 remains a preclinical Gilgamesh programme listed on the company pipeline; recent 2026 financing supports continued development of retained pipeline assets. View profile context | Preclinical Programme phase | Gilgamesh Pharma Pipeline - GM-5022 company-website · Gilgamesh Pharma · Jun 27, 2026 · Verified | 2 sources 0 trials · 0 papers preclinical-data | |
M1/M4 Muscarinic Agonist Preclinical Programme (Schizophrenia) Gilgamesh continues to list an M1/M4 muscarinic agonist programme for schizophrenia; no clinical-stage registration was found in this pass. View profile context | Preclinical Programme phase | Gilgamesh Pharma Pipeline - Muscarinic Programme company-website · Gilgamesh Pharma · Jun 27, 2026 · Verified | 2 sources 0 trials · 0 papers Forecast saved | |
JOUR-5700 Programme (AUD) — Pre-Phase 1 JOUR-5700 remains a preclinical mescaline HCl AUD programme in public databases and historical company coverage; no ClinicalTrials.gov registration or recent Journey Colab clinical-start update was found in this pass. View profile context | Preclinical Programme phase | Mescaline HCl - Journey Colab drug-database · AdisInsight · Jun 26, 2026 · Verified Milestone: Company milestone · actual Dec 1, 2023 | 9 sources 0 trials · 0 papers Phase I started | |
KB-128 IND-Enabling Programme (AUD) — Trifunctional 5-HT2C Agonist / 2A+2B Antagonist KB-128 remains in IND-enabling/preclinical development for AUD, backed by a 2M NIAAA grant announced in September 2025. View profile context | Preclinical Programme phase | Kuleon Bioscience Science Platform company-website · Kuleon Bioscience · Jun 26, 2026 · Verified Milestone: preclinical-data · actual Jun 1, 2024 | 8 sources 0 trials · 0 papers Phase I started | |
LPH-48 Preclinical Programme LPH-48 remains a preclinical fast-follower to LPH-5, described by Lophora as a short-duration candidate with similar primary pharmacology. Lophora reported positive Phase 1 topline results for lead candidate LPH-5 on 2026-06-10, supporting continued platform development and Phase Ib entry for LPH-5. View profile context | Preclinical Programme phase | Lophora positive Phase 1 topline results for LPH-5 platform lead Press release · Lophora · Jun 10, 2026 · Verified | 3 sources 0 trials · 0 papers preclinical-data · likely Q1 2027 | |
MB-204 Programme (Rett Syndrome / Fragile X) — Phase 1 imminent MB-204 is moving toward Phase 1: Marvel selected Novotech as CRO in March 2026 after cGMP synthesis and GLP toxicology, while continuing Rett and Fragile X preclinical positioning. View profile context | Preclinical Programme phase | Untitled source Press release · BioSpace · Mar 30, 2026 · Verified Milestone: Funding milestone · actual Mar 30, 2026 | 10 sources 0 trials · 0 papers Forecast saved | |
MYCO-004 Preclinical Programme (Transdermal Tryptamine, SUD) MYCO-004 remains supported mainly by 2021 Mydecine disclosures as a patch-delivered tryptamine for SUD/smoking cessation. Mydecine changed its public company name to Noveris Health Sciences in February 2026; no recent MYCO-004 clinical-start confirmation was found. View profile context | Preclinical Programme phase | CSE Bulletin - Mydecine Name and Symbol Change exchange-notice · Canadian Securities Exchange / Newsfile · Feb 2, 2026 · Verified | 3 sources 0 trials · 0 papers Forecast saved | |
NBX-200 — GMP Formulation Development (Ab Initio Pharma) NBX-200 advanced in early 2026 with Neurala reporting Phase 1 data for second-generation DMT-harmala candidates; GMP formulation and manufacturing work for NBX-200 is underway with Ab Initio Pharma. View profile context | Preclinical Programme phase | Neurala Biosciences Company Profile company-website · Neurala Biosciences · Jun 27, 2026 · Verified | 4 sources 0 trials · 0 papers Forecast saved | |
Ariadne (4C-D) — Parkinson's Apathy (Ariadne Bio) Phase 1b study in Parkinson's apathy was planned for H1 2025 — launch not publicly confirmed. Developed through subsidiary Ariadne Bio (CEO: Shlomi Raz, ex-Goldman Sachs MD, founder of Eleusis, ex-President Beckley Psytech). View profile context | Preclinical Programme phase | Negev Labs — Official Website company-website · Negev Labs · Jun 26, 2026 · Verified | 3 sources 0 trials · 0 papers Phase I started | |
Athena — Prader-Willi Aggression / ADHD Impulsivity Athena remains an early/preclinical Palomar Labs programme; public support is thin, with investor-profile materials describing Athena Neurosciences for ADHD and the former Negev Labs site describing the broader venture-building model. View profile context | Preclinical Programme phase | Negev Labs Venture-Building Model company-website · Negev Labs · Jun 26, 2026 · Verified | 2 sources 0 trials · 0 papers Regulatory filing submitted | |
ELE-02 — Retinal Degeneration (Ophthalmology) ELE-02/ophthalmology neuroplastogen programme remains preclinical after Negev acquired the Beckley Psytech ophthalmology programme in late 2024; no IND filing was found in this pass. View profile context | Preclinical Programme phase | Negev Labs Company Site company-website · Negev Labs · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Regulatory filing submitted | |
HBL20017 — OCD / Tic Disorders (Hadassah BrainLabs) Preclinical completed with remarkable single-dose durability. No IND filed. Developed in collaboration with Hadassah BrainLabs Center for Psychedelic Research (Prof. Bernard Lerer) and synthesized by Pharmaron Inc. View profile context | Preclinical Programme phase | A Novel Non-Hallucinogenic Psychedelic for OCD and Tic Disorder — IJNP 2025 peer-reviewed · International Journal of Neuropsychopharmacology · Aug 1, 2025 · Verified Milestone: Efficacy data · actual Aug 1, 2025 | 2 sources 0 trials · 0 papers Regulatory filing submitted | |
ALA-002 — Phase 2a/2b Social Anxiety in ASD (University of Sydney) Phase 2a/2b preparation. UK-based CDMO contracted December 2025 for drug substance manufacture. ALA-002 capsule encapsulation on production schedule. Phase 2 protocol completed with University of Sydney (Dr. Adam Guastella, Michael Crouch Chair in Child and Youth Mental Health). Trial expected to initiate 2026 in Australia. No CTA/TGA approval yet announced. View profile context | Preclinical Programme phase | PharmAla Contracts UK CDMO for ALA-002 Drug Substance Manufacture Press release · GlobeNewswire · Dec 15, 2025 · Verified Milestone: Company milestone · actual Dec 15, 2025 | 6 sources 0 trials · 0 papers Phase II started | |
APA-001 — Preclinical Development (Trauma/TBI/Neurological) APA-01 is being advanced through Restora Neurosciences after a 2026 definitive SPV agreement, with the stated objective of a first FDA IND; preclinical proof-of-concept and patent evidence remain the core support. View profile context | Preclinical Programme phase | PharmAla Forms Restora Neurosciences SPV for APA-01 Clinical Development Press release · BioSpace / PharmAla Biotech · May 1, 2026 · Verified | 5 sources 0 trials · 0 papers Regulatory filing submitted | |
AUD Neuroplastogen — NIH/NIAAA-funded IND-enabling NIH/NIAAA SBIR grant-funded IND-enabling studies. Targeting serotonergic and glutaminergic pathways in AUD. Initial preclinical safety and toxicity assessments passed. View profile context | Preclinical Programme phase | Psilera Secures NIH Grant for AUD Research Press release · BioSpace · Oct 3, 2025 · Verified Milestone: Funding milestone · actual Oct 3, 2025 | 2 sources 0 trials · 0 papers Regulatory filing submitted | |
PSIL-006 — IND-enabling bvFTD Late IND-enabling. May 2026 seed financing is intended to advance PSIL-006 toward first-in-human trials in 2027. View profile context | Preclinical Programme phase | Psilera — PSIL-006 Pipeline Page company-website · Psilera · Jun 27, 2026 · Verified | 12 sources 0 trials · 0 papers Phase I started · likely Q2 2027 | |
PSIL-025 — Preclinical Anxiety Preclinical non-hallucinogenic candidate for anxiety disorders. Public detail remains sparse, and Psilera’s 2026 financing/news emphasizes PSIL-006 as lead asset. View profile context | Preclinical Programme phase | Psychedelic Alpha — Psychedelic Drug Development Tracker industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified Milestone: Preclinical started · actual May 17, 2024 | 4 sources 0 trials · 0 papers Preclinical completed | |
PSY-05 — Preclinical (GAD / PTSD) Public sources conflict on naming: Psy March 2025 highlights use PSY-05 for an oral pain/PTSD programme entering IND-enabling, whereas the current Psy site lists PSY-05001 for pain/PTSD and does not list a separate PSY-05. Synapse tracks PSY-05 as pending/preclinical. Keep this record visible as a mapping-cleanup and waiting-on-news item. View profile context | Preclinical Programme phase | Synapse Psy Therapeutics organization pipeline snapshot drug-database · Synapse / PatSnap · Jun 26, 2026 · Verified | 3 sources 0 trials · 0 papers programme-status-update | |
PSY-05001 — IND-Enabling (Chronic Pain / PTSD Sleep) IND-enabling studies in progress. Lead optimization completed. Preclinical efficacy confirmed in neuropathic, inflammatory, and post-operative pain models (Mar 2025). US composition of matter patent allowed through 2042. Company raising $10M convertible note to advance into Phase 1 FIH study and enable Series A. View profile context | Preclinical Programme phase | Psy Therapeutics — Pipeline (Patent Disclosure) company-website · Psy Therapeutics · Jun 26, 2026 · Verified Milestone: ip-milestone · actual Jun 1, 2024 | 4 sources 0 trials · 0 papers Regulatory filing submitted | |
Natural Psilocybin R&D Programme (Irvine Labs + Filament Health acquisition) Red Light completed the Filament Health acquisition on April 30, 2026, adding botanical psilocybin IP, GMP manufacturing, and clinical authorization assets; Irvine Labs import activity remains relevant to natural psilocybin R&D. View profile context | Preclinical Programme phase | Filament PEX010 Selected by UCSF for Study Press release · Yahoo Finance / Red Light Holland · May 1, 2026 · Verified | 7 sources 0 trials · 0 papers Forecast saved | |
CX157 + DMT — Preclinical Development Preclinical platform development. No IND filed for the CX157+DMT combination. CX157 previously had an FDA IND (approved Jan 2007 under CeNeRx) but status unclear after 2013 development termination. Patent WO2024108195A1 filed Nov 2023 covering CX157 + tryptamine combinations. Company seeks partnerships and collaborations. View profile context | Preclinical Programme phase | Remedi Therapeutics — Company Website company-website · Remedi Therapeutics · Jun 26, 2026 · Verified | 9 sources 0 trials · 0 papers Regulatory filing submitted | |
RE245 — Preclinical / IND-Enabling RE245 remains Reunion's lead non-psychedelic discovery-stage 5-HT2A agonist. Reunion reiterated in February, May, and June 2026 that it plans to file an IND in 2026; no IND submission or clearance announcement was found in this pass. View profile context | Preclinical Programme phase | Reunion Neuroscience Programs - RE245 company-website · Reunion Neuroscience · Jun 27, 2026 · Verified | 4 sources 0 trials · 0 papers Regulatory filing submitted · likely Q4 2026 | |
Bucillamine — Nerve Agent Countermeasure (DRDC) Research study with Defence R&D Canada (DRDC) — Suffield Research Centre nearing completion (targeted Sep 2025). Bucillamine for nerve agent-induced brain injury (sarin, soman, tabun, VX). Health Canada approval for strategic stockpiling targeted 2026. Five Eyes procurement opportunity (Canada, US, UK, Australia, NZ). View profile context | Preclinical Programme phase | Revive Therapeutics — Pipeline company-website · Revive Therapeutics · Jun 27, 2026 · Verified | 2 sources 0 trials · 0 papers Forecast saved | |
Bucillamine — Phase 2 Long COVID Phase 2 Long COVID study planned. FDA Type C meeting (Jun 2024) recommended new IND with cross-reference to prior COVID-19 IND (NCT04504734, Phase 3, terminated by DSMB). IND submission targeted Q1 2025; FDA approval of protocol expected Q2 2025. No confirmation IND has been filed. Extremely limited cash ($14,560 as of Jun 2025). View profile context | Preclinical Programme phase | Revive Therapeutics — Pipeline company-website · Revive Therapeutics · Jun 27, 2026 · Verified | 4 sources 0 trials · 0 papers Phase II started | |
SPT-348 Preclinical Programme (Cluster Headache/TRD) SPT-348/Glyph2BLSD remains preclinical; Seaport's June 2026 SEC update says first-in-human-enabling studies are expected by year-end 2027. View profile context | Preclinical Programme phase | Seaport Therapeutics Pipeline - Glyph2BLSD company-website · Seaport Therapeutics · Jun 27, 2026 · Verified | 3 sources 0 trials · 0 papers Forecast saved | |
Psilocybin + Beta-Carboline Buccal Film — Feasibility Study (Anorexia Nervosa) Shortwave continues to position its psilocybin buccal film around an anorexia feasibility study; 2025 coverage says the company is working to show safe delivery and clinical-practice integration. View profile context | Preclinical Programme phase | Shortwave Explains Potential of Psilocybin Therapy for Anorexia industry-media · Psychedelic Health · Dec 10, 2025 · Verified Milestone: Company milestone · actual Dec 4, 2025 | 9 sources 0 trials · 0 papers preclinical-data | |
SP-26 Preclinical Programme (Fibromyalgia / Chronic Pain) — Ketamine Implant SP-26 remains a preclinical ketamine-loaded implant programme for fibromyalgia/chronic pain, with 2025 minipig endpoint data and Sever Pharma scale-up work. View profile context | Preclinical Programme phase | Sever Pharma Expands Partnership with Silo on SP-26 partner-announcement · Sever Pharma Solutions · Aug 14, 2025 · Verified | 5 sources 0 trials · 0 papers preclinical-data | |
SPC-15 IND-Enabling Programme (PTSD) — Columbia University licence SPC-15 remains in IND-enabling work for PTSD/stress-induced anxiety, with GLP safety work at Frontage and public 2025 plans for IND submission and potential 2026 Phase 1. View profile context | Preclinical Programme phase | Silo Plans SPC-15 IND Submission and Potential Phase 1 in 2026 industry-media · Quiver Quantitative · Jul 1, 2025 · Verified | 8 sources 0 trials · 0 papers Regulatory filing submitted | |
SVN-015 Preclinical Programme (Stimulant Addiction, NIDA-funded) SVN-015 was accepted into the NIDA Addiction Treatment Discovery Program on 2025-12-03 for methamphetamine and cocaine addiction. NIDA support covers cardio-risk and preclinical efficacy studies; the next watch item is 2026 preclinical readout or IND-enabling guidance. View profile context | Preclinical Programme phase | SVN-015 accepted into NIDA Addiction Treatment Discovery Program Press release · Solvonis Therapeutics · Dec 3, 2025 · Verified Milestone: Funding milestone · actual Dec 1, 2025 | 2 sources 0 trials · 0 papers preclinical-data · likely Q4 2026 | |
SVN-SDN-14 Preclinical Programme (PTSD) SVN-SDN-14 has produced positive preclinical PTSD data, and Solvonis selected SVN-114 as the lead candidate from the series in 2026. View profile context | Preclinical Programme phase | Solvonis SVN-114 Programme company-website · Solvonis Therapeutics · Jun 27, 2026 · Verified | 3 sources 0 trials · 0 papers Forecast saved | |
SON-001 — TBI / Neuropsychiatric Development Pre-clinical stage. No Soneira-sponsored clinical trial registered on ClinicalTrials.gov. No IND filing or FDA pre-IND meeting publicly disclosed. Stanford MISTIC study (NCT04313712, observational, NOT FDA-regulated) provides foundational clinical data. Two patent applications filed jointly with Stanford (Sep 2023). Company path forward unclear after loss of founding advisor Nolan Williams (Oct 2025). View profile context | Preclinical Programme phase | Nolan Williams Obituary — Stanford Medicine Press release · Stanford Medicine · Dec 1, 2025 · Verified Milestone: Company milestone · actual Oct 8, 2025 | 9 sources 0 trials · 0 papers Regulatory filing submitted | |
Novel Benzofuran Entactogen Library Preclinical Programme TACT833/411/523 remains a preclinical Tactogen entactogen programme. Public evidence is mostly undated company pipeline language, older patent applications, and drug-database tracking; no fresh trial, IND, financing, or candidate-selection update was found in the June 2026 sweep. Keep as waiting-on-news. View profile context | Preclinical Programme phase | TACT411/833 Drug Profile drug-database · PatSnap Synapse · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers preclinical-data | |
TACT908 Preclinical Programme (Cluster Headache) TACT908 remains a preclinical cluster-headache programme, supported by Tactogen pipeline/patent material and drug-database tracking. View profile context | Preclinical Programme phase | Tactogen Drug Pipeline Profile drug-database · PatSnap Synapse · Jun 26, 2026 · Verified | 3 sources 0 trials · 0 papers Forecast saved | |
R-192 Norketamine Programme (MDD) — Phase 1 PK Study R-192 remains clinically ready/preclinical, with public reporting expecting a Phase 1 PK study in H2 2026 and Tasman continuing oral ketamine/norketamine development activity. View profile context | Preclinical Programme phase | Tasman Therapeutics Company Site company-website · Tasman Therapeutics · Jun 27, 2026 · Verified | 3 sources 0 trials · 0 papers Forecast saved | |
Terran Biosciences Eplivanserin + Volinanserin (5-HT2A Antagonist Psychedelic Combos) Compound not specified | Psychedelic + 5-HT2A Antagonist Combinations Preclinical combo development. Eplivanserin and volinanserin have extensive Phase 3 safety databases (15,000+ patients). Exclusive license from University of Maryland Baltimore (Mar 2022) for psilocybin + 5-HT2A antagonist combination patents and data. 200+ patent applications across 30+ families covering prodrugs of psilocin, LSD, 2C-B, methylone, long-acting MDMA, oral DMT, 5-MeO-DMT. View profile context | Preclinical Programme phase | Terran Biosciences — Website company-website · Terran Biosciences · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Regulatory filing submitted |
TerXT — Phase 1 PK Bridging (Schizophrenia, 505(b)(2)) TerXT remains a non-psychedelic schizophrenia prodrug programme; Terran continues to position it for 505(b)(2)-style development, with PK bridging expected around the Cobenfy/KarXT regulatory window. View profile context | Preclinical Programme phase | Terran Biosciences Pipeline - TerXT company-website · Terran Biosciences · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Regulatory filing submitted | |
TN-001 — IND-enabling MDD/PTSD IND-enabling studies. ACNP 2026 preclinical data presented. CEO Lykins states wrapping up preclinical efforts and progressing into clinical trials. IND filing timeline not publicly disclosed. View profile context | Preclinical Programme phase | Transneural Therapeutics — Website company-website · Transneural Therapeutics · Jun 27, 2026 · Verified | 6 sources 0 trials · 0 papers Regulatory filing submitted | |
MEO201 — 5-MeO-DMT Phase 2 Preparation Usona reports completed CMC, manufacturing, protocol, vendor-selection, and study start-up work positioning MEO201 to move into Phase 2 efficacy studies. No public Phase 2 launch registration or first-patient announcement was found in the June 2026 sweep, so this remains a waiting-on-news Phase 2-start watch item. View profile context | Preclinical Programme phase | Usona Institute — 5-MeO-DMT Programme Page company-website · Usona Institute · Jun 26, 2026 · Verified Milestone: Preclinical completed · actual Dec 1, 2024 | 5 sources 0 trials · 0 papers Phase II started · likely Q4 2026 | |
XYL-1001 IND-Enabling Programme (Depression/Anxiety) XYL-1001 remains in IND-enabling/manufacturing scale-up, with Xylo reporting rebrand/pipeline progress in 2025 and first-in-human trials planned around mid-2026. View profile context | Preclinical Programme phase | Xylo Bio Company Site company-website · Xylo Bio · Jun 26, 2026 · Verified | 9 sources 0 trials · 0 papers Forecast saved | |
SAI Anti-Inflammatory Platform - CNS/Systemic Discovery Discovery-stage serotonergic anti-inflammatory platform extending 5-HT2A precision agonism beyond the ophthalmology lead into CNS neurodegeneration and systemic inflammatory indications. Company site says 2A is in stealth and preparing for clinical study initiation, but no platform-specific IND or trial has been announced. View profile context | Discovery Programme phase | 2A Biosciences - Company Website company-website · 2A Biosciences · Jun 26, 2026 · Verified Milestone: Discovery started | 3 sources 0 trials · 0 papers Preclinical started | |
XOB Discovery Programme (Bipolar Disorder) XOB remains a discovery-stage bipolar disorder programme, supported by ASRI 2024 announcement and peer-reviewed pharmacology characterisation. View profile context | Discovery Programme phase | ASRI Latest News - XOB Bipolar Discovery company-website · Alexander Shulgin Research Institute · Jun 26, 2026 · Verified Milestone: Discovery started · actual May 1, 2024 | 5 sources 0 trials · 0 papers preclinical-data | |
Non-hallucinogenic 5-HT2A/2C agonists — OUD/TRD discovery NIH/NIDA-funded discovery and lead-optimization programme for non-hallucinogenic 5-HT2A/2C receptor agonists, initially focused on OUD with TRD also listed in company pipeline language. View profile context | Discovery Programme phase | Psychedelic Alpha — Non-Hallucinogenic Psychedelic Pipeline Tracker industry-media · Psychedelic Alpha · Jun 26, 2026 · Verified | 5 sources 0 trials · 0 papers Preclinical started · likely Q4 2026 | |
MIA Neuroplastogen Discovery Platform (Yeast Biomanufacturing) Discovery-stage platform remains active; Biomia announced an IRLAB collaboration in January 2026 to evaluate drug candidates using IRLAB's Integrative Screening Process. View profile context | Discovery Programme phase | Biomia - AI and Yeast-Based CNS Drug Discovery company-website · Biomia · Jun 26, 2026 · Verified Milestone: Company milestone · actual Jan 1, 2022 | 8 sources 0 trials · 0 papers candidate-selection | |
Biosynthetic Psilocybin / Tryptamine Platform Precision fermentation platform for psilocybin, DMT, and tryptamine analogues. Cleveland Clinic MOU (2020) for clinical trial supply. No clinical trials initiated. No public updates since mid-2020. View profile context | Discovery Programme phase | CB Therapeutics — Precision Synthetic Biology company-website · CB Therapeutics · Jun 26, 2026 · Verified | 8 sources 0 trials · 0 papers preclinical-data | |
DMT / Tryptamine Analogues — Precision Fermentation Discovery Discovery/supply-platform programme. CB Therapeutics has demonstrated DMT and tryptamine analogue biosynthesis in yeast and now presents TryptageniX as a rare-alkaloid precision-fermentation programme; no sponsor-led clinical trial has been disclosed. View profile context | Discovery Programme phase | CB Therapeutics — Precision Synthetic Biology company-website · CB Therapeutics · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers preclinical-data | |
Elk1 Neuroplastogen Discovery Programme (Depression) Discovery/lead-optimization stage; Elkedonia launched with an 11.25M seed round in June 2025 and recent coverage continues to describe first-in-class Elk1 inhibitors for treatment-resistant depression. View profile context | Discovery Programme phase | Elkedonia Raises 11.25M Seed Round to Advance Neuroplastogen Therapy industry-media · Pharmaceutical Technology · Jun 19, 2026 · Verified Milestone: Funding milestone · actual Jun 11, 2025 | 8 sources 0 trials · 0 papers candidate-selection | |
ET-01 — Preclinical Discovery iPSC-based high-throughput neuroplasticity screening underway. ET-01 identified as lead from botanical compound library. Preclinical characterisation in progress — no IND filed, no ClinicalTrials.gov entries. Company is entirely in discovery/preclinical stage. $3.58M seed capital secured Sep 2024, SEC Form D filed Oct 2024 for up to $10M raise. Team building with world-class SAB: Robin Carhart-Harris, Adam Gazzaley, Sarah O'Connor. View profile context | Discovery Programme phase | Psychedelic Alpha — Entheos Labs Coverage industry-media · Psychedelic Alpha · Jun 27, 2026 · plausible | 5 sources 0 trials · 0 papers preclinical-data | |
Equulus Therapeutics Serotonin Releaser Platform (MDMA-Inspired & Fenfluramine-Class) Compound not specified | Serotonin Releaser Platform - PTSD/SUD Discovery Discovery-stage 5-HT releaser platform covering an MDMA-inspired PTSD asset and a next-generation fenfluramine-class programme. Equulus lists candidate selection as the next milestone; October 2025 secondary coverage also describes the 5-HT releaser/MDMA analog and related non-psychedelic pipeline. No IND has been disclosed for the serotonin-releaser assets. View profile context | Discovery Programme phase | Bruce Blough — RTI International Expert Profile company-website · RTI International · Jun 27, 2026 · Verified | 7 sources 0 trials · 0 papers Discovery completed |
PSY-01 — Lead Optimization (MDD / Parkinson's) Lead optimization. NIMH SBIR Phase I funded ($458,385) — "Development of brain-penetrant COMT inhibitors for the treatment of depressive disorders." In-vivo biomarker data (PRT mouse model) targeted Mar 2025. Novel non-nitrocatechol scaffold from X-Chem DEL screen avoids liver toxicity and poor CNS penetration of existing COMT inhibitors. View profile context | Discovery Programme phase | Psy Therapeutics — Pipeline company-website · Psy Therapeutics · Jun 26, 2026 · Verified | 2 sources 0 trials · 0 papers preclinical-data | |
PSY-02 — Lead Optimization (Alzheimer's / Tauopathies) Current Psy site lists PSY-02 as a tau oligomerization inhibitor rapidly advancing through lead optimization. March 2025 company highlights said cell-based assays confirmed tau anti-aggregation and Michael J. Fox Foundation financed in-vivo proof-of-principle readouts were expected in 2H25; Synapse still lists PSY-02 as preclinical in its 2026 snapshot. No public PoC readout was found in this sweep. View profile context | Discovery Programme phase | Psy Therapeutics Pipeline — MJFF-Funded Tau Program company-website · Psy Therapeutics · Jun 27, 2026 · Verified Milestone: Funding milestone · actual Jan 1, 2024 | 5 sources 0 trials · 0 papers preclinical-data | |
PSY-06 — Lead Optimization (MDD) Psy Therapeutics current pipeline does not list a separate PSY-06 asset. Synapse tracks PSY-06 as pending/preclinical for depressive disorder in its 2026 organization snapshot and direct drug profile. Keep as secondary-source-only pending company confirmation. View profile context | Discovery Programme phase | Psy Therapeutics — Pipeline company-website · Psy Therapeutics · Jun 27, 2026 · Verified | 3 sources 0 trials · 0 papers programme-status-update | |
CX157 + 5-MeO-DMT - Oral Combination Discovery Discovery-stage oral combination concept pairing CX157, a selective reversible MAO-A inhibitor, with 5-MeO-DMT or other 5-HT2A agonists. Public evidence is limited to Remedi platform language and a published patent family; no IND or trial has been found. View profile context | Discovery Programme phase | Remedi Therapeutics - Redefining DMT Delivery company-website · Remedi Therapeutics · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Preclinical started | |
Undisclosed Neuroplastogen Programme 2 - Discovery Undisclosed second programme in Transneural broader small-molecule neuroplastogen pipeline. Public materials confirm two additional programmes beyond TN-001, but mechanism, candidate name, and indication remain undisclosed. View profile context | Discovery Programme phase | Transneural Therapeutics - Pipeline company-website · Transneural Therapeutics · Jun 26, 2026 · Verified | 4 sources 0 trials · 0 papers Discovery completed |
Programme phase
Esketamine MDD with acute suicidal ideation (MDSI)
Approved for depressive symptoms in MDD with acute suicidal ideation or behaviour (2020).
View profile contextPublication · Cureus / PubMed Central · Feb 1, 2024 · Verified
Milestone: Regulatory review accepted · actual Aug 1, 2016
4 sources
2 trials · 0 papers
No forecast saved
Programme phase
Press release · Johnson & Johnson · Jan 21, 2025 · Verified
Milestone: Regulatory approved · actual Jan 21, 2025
9 sources
7 trials · 0 papers
No forecast saved
Programme phase
KETARx FDA Approval Programme (Surgical Pain) — ANDA #217858
FDA ANDA #217858 approved August 8, 2025; U.S. commercialisation rights sold December 2025 (upfronts + milestones potentially exceeding $25M)
View profile contextPress release · PharmaTher · Aug 11, 2025 · Verified
Milestone: Regulatory approved · actual Aug 8, 2025
4 sources
0 trials · 0 papers
No forecast saved
Programme phase
COMP360 TRD (Phase 3)
Rolling NDA submission underway; final submission expected Q4 2026.
View profile contextPress release · Compass Pathways · Jul 7, 2026 · Verified
Milestone: Phase III completed · actual Jul 7, 2026
10 sources
6 trials · 0 papers
No forecast saved
Programme phase
NRX-100 — IV Ketamine NDA Filing
NRx reported on 2026-05-18 that full NRX-100 NDA submission was expected in Q2 2026, with Module 3 already filed and a request for rolling review. PDUFA timing remains TBD until FDA acceptance/review status is announced.
View profile contextPress release · NRx Pharmaceuticals · Mar 16, 2026 · Verified
Milestone: Regulatory filing submitted
4 sources
0 trials · 0 papers
nda-submitted · likely Q2 2026
Eventual approval estimate: 35%
Programme phase
MDMA-AT PTSD — NDA 215455 (Post-CRL)
Post-CRL programme remains paused pending a new FDA-aligned Phase 3/resubmission path. Public Lykos materials still describe pursuit of FDA approval, but no new pivotal trial start or resubmission date was found in the June 2026 review.
View profile contextcompany-website · Resilient Pharmaceuticals · Jun 27, 2026 · Verified
4 sources
3 trials · 2 papers
Phase III started
Eventual approval estimate: 25%
Programme phase
Panorama (GAD Phase 3)
Enrollment rapidly progressing; includes US and European sites. Topline data expected H2 2026.
View profile contextConference · Yahoo Finance · Mar 16, 2026 · Verified
6 sources
3 trials · 1 papers
Phase III topline · likely Q4 2026
Eventual approval estimate: 40%
Programme phase
Voyage (GAD Phase 3)
Enrollment ~80% complete as of Feb 2026; topline data expected early Q3 2026
View profile contextConference · Yahoo Finance · Mar 16, 2026 · Verified
7 sources
3 trials · 1 papers
Phase III topline · likely Q3 2026
Eventual approval estimate: 45%
Programme phase
Ascend (MDD Phase 3)
Sites activated; first patient dosing anticipated early Q2 2026. ~175 pts (2:1:2 randomization: 100µg, 50µg, placebo).
View profile contextPress release · Definium Therapeutics · Jun 22, 2026 · Verified
3 sources
1 trials · 1 papers
Phase III started · likely Q2 2026
Programme phase
Emerge (MDD Phase 3)
Fully enrolled (~140 pts). Topline data expected late Q2 2026.
View profile contextPress release · Definium Therapeutics · Jun 22, 2026 · Verified
Milestone: Phase III topline · actual Jun 22, 2026
5 sources
1 trials · 1 papers
Phase III topline · likely Q2 2026
Eventual approval estimate: 30%
BPL-003 TRD (acquired from AtaiBeckley)
Programme acquired with AtaiBeckley in July 2026. Development history and milestone detail sit on the AtaiBeckley record; this candidate tracks Lilly ownership from the acquisition onward.
View profile contextNo source link saved
Latest recorded event: Jul 16, 2026 · Licensing deal
0 sources
0 trials · 0 papers
No forecast saved
Programme phase
GH001 TRD — Global Phase 3
Phase 3 global pivotal program planned for 2026 initiation following FDA clinical hold lift (Jan 5, 2026) and positive Phase 2b results
View profile contextcompany-website · GH Research · Jun 27, 2026 · Verified
7 sources
2 trials · 1 papers
Phase III started
Eventual approval estimate: 50%
Programme phase
PARADIGM — HLP003 Phase 3 (APPROACH + EMBRACE)
APPROACH Phase 3 enrollment has surpassed 86%, with dosing ongoing and topline results still expected in Q4 2026. EMBRACE and EXTEND remain part of the broader PARADIGM HLP003 registrational programme.
View profile contextRegulatory filing · SEC / Stock Titan · Jul 21, 2026 · Verified
Milestone: Enrollment complete · actual Jul 21, 2026
8 sources
0 trials · 0 papers
Phase III topline · likely Q4 2026
Eventual approval estimate: 55%
Programme phase
NRX-101 — Suicidal Bipolar Depression Accelerated Approval
The original suicidal bipolar depression accelerated-approval path remains in preparation, while NRx separately reported FDA expanded-access clearance for NRX-101/TMS and initiation of the pivotal SPARC-TMS study in June 2026.
View profile contextPress release · PR Newswire · Mar 1, 2024 · Verified
Milestone: Phase III topline · actual Mar 1, 2024
3 sources
0 trials · 0 papers
nda-submission · likely Q3 2026
Eventual approval estimate: 35%
Programme phase
TSND-201 EMPOWER-1 Phase 3 (PTSD) — NCT07456696
EMPOWER-1 Phase 3 recruiting (NCT07456696): 300 patients, two doses vs placebo, 4 weekly oral doses + 8 weeks observation. FDA Breakthrough Therapy Designation July 2025. Otsuka acquisition of Transcend announced March 2026 ($700M upfront + $525M milestones = $1.225B).
View profile contextRegistry update · ClinicalTrials.gov · Jun 12, 2026 · Verified
Milestone: Phase III started
9 sources
0 trials · 0 papers
Forecast saved
Programme phase
RECONNECT — RE104 PPD Phase 2→Phase 3
FDA granted Breakthrough Therapy Designation for luvesilocin in PPD on 2026-02-23 after positive RECONNECT Phase 2 data. Reunion says it has aligned with FDA on a registrational path and expects a single pivotal Phase 3 trial in 2026, with the next public watch item being trial registration or first-patient-in.
View profile contextclinical-trial-registry · ClinicalTrials.gov · May 14, 2026 · Verified
5 sources
0 trials · 0 papers
Phase III started · likely Q4 2026
Eventual approval estimate: 50%
Programme phase
SVN-001 More-KARE Phase 3 (AUD)
SVN-001 remains Solvonis lead Phase 3 programme for severe AUD. Solvonis FY2025 results on 2026-04-29 said the board is prioritising advancement through Phase 3 completion; the official SVN-001 page describes the n=280 MORE-KARE trial, Q3 2024 start, trial completion in 2027, data readout in 2028, and possible UK marketing-authorisation submission in 2029.
View profile contextcompany-website · Solvonis Therapeutics · Jun 26, 2026 · Verified
Milestone: Phase II topline · actual Jan 1, 2021
6 sources
0 trials · 0 papers
Phase III completed · likely Q4 2027
Eventual approval estimate: 40%
Programme phase
R-107 ROCKET Phase 3 Programme (TRD) — Pivotal
ROCKET Phase 3 pivotal trial enrollment started H2 2025. BEDROC Phase 2 published in Nature Medicine (2024). 106 patients in open-label compassionate supply >2 years with no dissociation or significant AEs. Raising $175M Series A for Phase 3 and commercialisation. FDA submission targeted 2027.
View profile contextcompany-website · Tasman Therapeutics · Jun 26, 2026 · Verified
Milestone: Phase III started · actual Apr 1, 2025
8 sources
0 trials · 0 papers
Forecast saved
Programme phase
TSND-201 Phase 3 Programme (PTSD)
TSND-201 is now in Phase 3 for PTSD. EMPOWER-1 (NCT07456696) is recruiting, with 300 estimated participants and estimated primary completion in December 2027. Transcend published IMPACT-1 Phase 2 data in JAMA Psychiatry, received FDA Breakthrough Therapy Designation in July 2025 and a Commissioner's National Priority Voucher in April 2026, and completed its acquisition by Otsuka in June 2026.
View profile contextPress release · Transcend Therapeutics · Jun 12, 2026 · Verified
Milestone: Funding milestone · actual Mar 27, 2026
7 sources
0 trials · 0 papers
Phase III topline · likely Q1 2028
Programme phase
uAspire (PSIL301) — Psilocybin MDD Phase 3
uAspire (NCT06308653) remains the active Phase 3 MDD study. Usona has an official Phase 3 sponsor statement on uAspire, and industry reporting in April 2026 said Usona confirmed receipt of an FDA Commissioner National Priority Voucher for psilocybin in MDD.
View profile contexttrial-registry · ClinicalTrials.gov · Jun 1, 2026 · Verified
6 sources
2 trials · 0 papers
nda-submission · likely Q4 2026
Eventual approval estimate: 55%
Bretisilocin — Phase 2a MDD (AbbVie/Gilgamesh)
AbbVie completed its acquisition of bretisilocin in October 2025. NCT06236880 remains recruiting as an expanded Phase 2a MDD study, with ClinicalTrials.gov listing 124 estimated participants and estimated primary completion in October 2026.
View profile contextcompany-website · AbbVie · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Phase II topline · likely Q4 2026
Eventual approval estimate: 40%
Programme phase
News / media · PharmaTimes · Dec 16, 2024 · Verified
Milestone: Phase II topline · actual Dec 16, 2024
4 sources
0 trials · 0 papers
No forecast saved
Programme phase
APEX-52 — PATHFINDER-52 Phase 2b PTSD (n=294, Canada)
APEX-52 remains Apex's take-home microdose psilocybin programme. The current Apex strategy page says APEX is advancing dual drug assets for PTSD/depression and will move to Phase 3 after Phase 2b completion; the 2024 FDA IND filing supported a Yale PK/driving study intended to inform PATHFINDER-52. No 2026 enrollment or topline disclosure was found.
View profile contextcompany-website · Apex Labs · Jun 26, 2026 · Verified
7 sources
0 trials · 0 papers
Phase II topline · likely Q4 2027
Programme phase
APEX-90 — SUMMIT-90 Phase 2b PTSD (n=160, Canada + Israel)
SUMMIT-90 Phase 2b remains the active APEX-90 macrodose PTSD/depression programme. Apex expanded the study to two Israeli sites in June 2025, and its current strategy page continues to frame Phase 2b completion as the trigger for Phase 3 and regulatory-approval planning.
View profile contextcompany-website · Apex Labs · Jun 26, 2026 · Verified
9 sources
0 trials · 0 papers
Phase II topline · likely Q4 2027
Programme phase
ReConnection — BPL-003 TRD Phase 3
Phase 3 ReConnection 1 and ReConnection 2 targeted Q2 2026 following successful EOP2 meeting (March 3, 2026). 8 mg selected as primary dose.
View profile contextcompany-website · AtaiBeckley · Jun 27, 2026 · Verified
6 sources
0 trials · 1 papers
Phase III started
Eventual approval estimate: 45%
Programme phase
EMP-01 SAD — Phase 2a (UK)
Phase 2a complete; positive safety and exploratory efficacy signal. Phase 2b in larger population to follow.
View profile contextPress release · AtaiBeckley Investor Relations · Feb 26, 2026 · Verified
Milestone: Phase II topline · actual Feb 26, 2026
3 sources
0 trials · 0 papers
Phase II started
Eventual approval estimate: 15%
Programme phase
ELUMINA — VLS-01 TRD Phase 2
ELUMINA (NCT06524830) is recruiting in treatment-resistant depression. AtaiBeckley reported in May 2026 that the Phase 2 study is progressing as planned, with topline results anticipated in Q4 2026.
View profile contextcompany-press-release · AtaiBeckley · May 12, 2026 · Verified
3 sources
0 trials · 0 papers
Phase II topline · likely Q4 2026
Eventual approval estimate: 20%
Programme phase
BMND08 Phase 2 Programme (Depression/Anxiety in Alzheimer's)
BMND08 Phase 2 completed with positive results reported 2024-02-29. Biomind said it intended to progress BMND08 to Phase 3 and seek Breakthrough Therapy Designation, but the June 2026 source sweep found no public Phase 3 start or BTD outcome. Keep as waiting-on-news.
View profile contextcompany-website · Biomind Labs · Jun 26, 2026 · Verified
Milestone: Regulatory review accepted · actual Dec 1, 2025
5 sources
0 trials · 0 papers
Phase III started
Programme phase
BREAKTHROUGH — BMB-101 Phase 2 (Absence Epilepsy / DEE)
Phase 2 BREAKTHROUGH positive (Jan 2026). Preparing global registrational programme for absence seizures and DEE. Phase 2 in Prader-Willi syndrome planned Q1 2026.
View profile contextcompany-website · Bright Minds Biosciences · Jun 27, 2026 · Verified
4 sources
0 trials · 0 papers
Phase III started
Eventual approval estimate: 45%
Programme phase
SYNP-101 Phase 2 Programme (OCD)
SYNP-101 has FDA IND clearance for a Phase 2 OCD trial and a related Frontiers in Psychiatry/Yale publication dated 2025-12-10. No public Phase 3 start, partnership, or sponsor status-changing update was found in the June 2026 sweep; keep as waiting-on-news pending new Ceruvia/Yale/B.More evidence.
View profile contextPublication · SSRN · Jan 1, 2026 · plausible
6 sources
0 trials · 0 papers
Phase III started
Programme phase
SYNP-101 Phase 2b Programme (Alcohol Use Disorder)
Phase 2b in planning; builds on Bogenschutz/NYU psilocybin AUD Phase 2a evidence
View profile contextPublication · SSRN · Jan 1, 2026 · plausible
5 sources
0 trials · 0 papers
Forecast saved
Programme phase
Psilocybin Phase IIb Programme (AUD, EU + Canada)
Phase IIb (CLA-PSY-201) enrollment and treatment completed; 154 subjects randomized across 12 sites in EU + Canada; topline data anticipated but repeatedly delayed (originally mid-2023, then Q3 2024, then early 2025)
View profile contextRegistry update · ClinicalTrials.gov · Jun 26, 2026 · Verified
11 sources
0 trials · 0 papers
Forecast saved
Programme phase
CLE-100 Phase 2 Programme (MDD)
SOLEO Phase 2 (NCT06340958) is completed on ClinicalTrials.gov. The registry lists 99 actual participants, actual primary completion in June 2025, actual study completion in November 2025, and a last update posted on 2026-06-23. No public topline results release was found in this pass.
View profile contextRegistry update · ClinicalTrials.gov · Jun 23, 2026 · Verified
Milestone: Phase II started · actual Jun 1, 2024
2 sources
0 trials · 0 papers
Phase II topline · likely Q3 2026
Programme phase
COMP360 PTSD
FDA accepted the PTSD IND in January 2026; late-stage Redefine study (COMP202) planned.
View profile contextPress release · Compass Pathways · Jan 7, 2026 · Verified
Milestone: Phase III planned
3 sources
7 trials · 0 papers
No forecast saved
Programme phase
ASD Phase 2a
Phase 2a ASD study NCT07303907 is recruiting. ClinicalTrials.gov lists 20 estimated participants, actual start on 2025-12-03, last update posted 2026-04-06, and primary completion expected August 2027; the prior 2026 topline expectation should be treated as superseded by the registry timeline.
View profile contextclinical-trial-registry · ClinicalTrials.gov · Apr 6, 2026 · Verified
Milestone: Phase II started · actual Oct 1, 2025
6 sources
1 trials · 0 papers
Phase II topline · likely Q4 2027
Eventual approval estimate: 10%
Programme phase
Zalsupindole Phase 2 Programme (MDD, at-home)
FDA has cleared Delix's randomized, double-blind, placebo-controlled Phase 2 design for DLX-001 in MDD, including at-home self-administration. The next public watch item is Phase 2 first-patient-in or trial registration.
View profile contextPress release · Cumulus Neuroscience / PR Newswire · May 28, 2026 · Verified
Milestone: Phase I topline · actual Dec 12, 2024
9 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Programme phase
Low-Dose Psilocybin Phase 2a Programme (Demoralization, UAB)
Phase 2a ongoing at UAB (NCT06341426); 60 patients; 5-week randomised double-blind; PI: Dr. Peter Hendricks
View profile contextcompany-website · Diamond Therapeutics · Jun 26, 2026 · Verified
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
Low-Dose Psilocybin Phase 2a Programme (GAD, Health Canada)
Phase 2a ongoing at Kingston Health Sciences Centre (KHSC), Ontario; first-ever Health Canada-approved at-home microdose psychedelic trial; first patient July 30, 2025
View profile contextcompany-website · Diamond Therapeutics · Jun 26, 2026 · Verified
10 sources
0 trials · 0 papers
Phase II topline
Programme phase
EMDMA-001 Phase 2 Open-Label (PTSD, TGA Authorised)
Open-label 12-month MDMA-AT study at PAX Centre Perth; MDMA supply for up to 70 patients secured; national expansion underway
View profile contextRegistry update · ANZCTR · Jun 27, 2026 · Verified
Milestone: Regulatory review accepted · actual Jul 1, 2023
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
TRP-8802 Phase 2a Programme (Binge Eating Disorder)
TRP-8802 oral psilocybin Phase 2a studies in BED and fibromyalgia are complete. Entropy reported peer-reviewed BED results on 2026-01-13 showing sustained binge-eating reductions through 14 weeks, and is using the TRP-8802 oral psilocybin data package to support the lead TRP-8803 IV psilocin programme.
View profile contextPress release · Entropy Neurodynamics / ASX · Jan 13, 2026 · Verified
Milestone: Phase II topline · actual Aug 1, 2022
5 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Programme phase
TRP-8803 Phase 2 Programme (BED, World-First IV Psilocin)
World's first clinical study of IV-infused psilocin; first patient dosed December 2025 at Swinburne University Melbourne; Cohort 1 complete, Cohort 2 enrolling
View profile contextPress release · Entropy Neurodynamics / ASX · Jun 16, 2026 · Verified
4 sources
0 trials · 0 papers
Phase II topline
Programme phase
PEX010 — Phase 2 Alcohol Use Disorder
Phase 2 POSITIVE DATA announced March 2025. Study at Psychiatric Centre Copenhagen (completed) and University of Washington. Additional Phase 2 for PTSD+AUD in veterans/first responders authorized by FDA July 2025 at University of Washington, funded by State of Washington.
View profile contextcompany-website · Filament Health · Jun 27, 2026 · Verified
6 sources
0 trials · 0 papers
Phase II topline
Programme phase
PEX010 — Phase 2 Brain Function & Wellbeing (UCL)
Two Phase 2 trials in partnership with University College London, MHRA approved (July 2025). Investigating effects on brain function, perception, and psychological well-being.
View profile contextcompany-website · Filament Health · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Phase II topline
Programme phase
PEX010 — Phase 2 Methamphetamine Use Disorder (UBC)
Phase 2 authorized at University of British Columbia for methamphetamine use disorder (MAUD). Health Canada regulatory pathway.
View profile contextcompany-website · Filament Health · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Phase II topline
Programme phase
PEX010 — Phase 2 Opioid Use Disorder (UPenn)
FDA authorized Phase 2 clinical trial at University of Pennsylvania (April 2025). Funded by Wellcome Leap. Studying psilocybin-assisted therapy for opioid use disorder.
View profile contextcompany-website · Filament Health · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Phase II topline
Programme phase
FREE001-TRD-201 Phase 2a (TRD) — FDA IND
Phase 2a dose-ranging trial underway (~100 patients) since H1 2024. FDA IND approved April 2024. Data readout expected ~2026. Yale spinout co-founded by Dr. John Krystal (Chair of Psychiatry, Yale). Total funding ~$10.5M.
View profile contextcompany-website · Freedom Biosciences · Jun 26, 2026 · Verified
Milestone: Phase II started · actual Jun 1, 2024
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
GH001 Bipolar II — Phase 2a POC
BDII-specific development remains quiet: the NCT05839509 registry is terminated and no follow-on BDII study was found. GH001 as a parent programme is advancing in TRD after FDA lifted the U.S. clinical hold on 2026-01-05 and the Phase 2b TRD results were published in JAMA Psychiatry on 2026-03-25, with global pivotal initiation targeted for 2026.
View profile contextcompany-website · GH Research · Jun 26, 2026 · Verified
8 sources
1 trials · 0 papers
No forecast saved
Programme phase
GH001 PPD — Phase 2a POC
Phase 2a completed Q4 2024. All 10 patients in remission — striking result. No further PPD development announced; resources focused on TRD Phase 3.
View profile contextcompany-website · GH Research · Jun 26, 2026 · Verified
8 sources
1 trials · 0 papers
No forecast saved
Programme phase
Blixeprodil Phase 2 Programme (MDD)
Phase 2a complete (positive topline January 2026); late-stage Phase 2b/3 planning underway for 2026
View profile contextPress release · Gilgamesh Pharma / PR Newswire · Jan 6, 2026 · Verified
Milestone: Phase II started · actual May 1, 2024
5 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Programme phase
HLP004 GAD — Phase 2 POC
Helus announced positive Phase 2 signal-detection topline results for HLP004 in GAD on 2026-03-05. The 20 mg adjunctive arm showed a 10.4-point mean HAM-A reduction at six weeks, with pooled six-month response/remission rates of 67%/39%. Next watch items are durability follow-up, a peer-reviewed publication, or Phase 3 guidance.
View profile contextPress release · Helus Pharma / GlobeNewswire · Mar 5, 2026 · Verified
Milestone: Phase II topline · actual Mar 5, 2026
4 sources
0 trials · 0 papers
Phase III planned · likely Q1 2027
Eventual approval estimate: 20%
Programme phase
PSX-001 PsiGAD Phase 2 → Phase 2b (GAD) — NCT05942911
Phase 2 PsiGAD1 complete with positive results (73 patients). Preparing multi-jurisdiction Phase 2b. Open IND with FDA. Clinical Advisory Board formed. Well-funded: $70M+ cash, runway into 2027. Nasdaq:IXHL / ASX:IHL.
View profile contextRegistry update · ANZCTR · Jun 27, 2026 · Verified
9 sources
0 trials · 0 papers
Phase II topline
Programme phase
KET01 Programme (TRD) — oral prolonged-release ketamine
Phase 2 (KET01-02) completed; Phase 3 pivotal trial planned (enrollment not yet confirmed); head-to-head vs Spravato data published
View profile contextcompany-website · Ketabon · Jun 26, 2026 · Verified
Milestone: phase-2-results · actual Aug 14, 2023
8 sources
0 trials · 0 papers
Forecast saved
Programme phase
MB22001 Phase 2B Cancer Distress (ACTRN12623000478617)
Phase 2B in 40 advanced-stage cancer patients ongoing. Existential distress, depression, anxiety in cancer as indication.
View profile contextcompany-website · MindBio Therapeutics · Jun 26, 2026 · Verified
6 sources
0 trials · 0 papers
Forecast saved
Programme phase
MB22001 Phase 2B MDD Programme (ACTRN12624000128594)
Phase 2B MDD completed in November 2025 and did not show superiority for repeated microdosed LSD over active placebo on MADRS at week 8. MindBio reported 29.9% MADRS reduction in the LSD arm versus 36.4% in placebo/caffeine (p=0.5469), with favorable tolerability and no serious adverse events in the LSD arm. The next watch item is whether MindBio publishes the dataset or redirects MB22001 development toward cancer distress/PMDD rather than MDD.
View profile contextcompany-website · MindBio Therapeutics · Jun 26, 2026 · Verified
Milestone: Phase II topline · actual Nov 13, 2025
12 sources
0 trials · 0 papers
Phase II publication · likely Q4 2026
Programme phase
MSP-1014 Phase 2 Programme (MDD) — acquired by Otsuka
MHRA-approved Phase 2 trial (NCT05624268) for MDD with ACT psychotherapy; may be deprioritized in favor of MSP-2020
View profile contextPress release · Newsfile / Otsuka and Mindset · Aug 31, 2023 · Verified
Milestone: Licensing deal · actual Sep 1, 2023
4 sources
0 trials · 0 papers
Phase II topline
Programme phase
MSX-06 Phase 2 Programme (TRD/OCD — Israel)
Israeli Ministry of Health approved clinical trial for OCD and depression; Phase 2 recruiting; PTSD study call for proposals in review; GMP production facility operational in Ness Ziona
View profile contextcompany-website · MSICS Pharma · Jun 26, 2026 · Verified
Milestone: Company milestone · actual Jan 1, 2022
8 sources
0 trials · 0 papers
Forecast saved
Programme phase
MYCO-001 Phase 2a Programme (PTSD, Veterans)
Phase 2a in veteran PTSD; partnership with Combat Stress (UK) and King's College London; PI: Dr. Rakesh Jetly
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Phase II topline
Programme phase
MYCO-001 Phase 2b Programme (Smoking Cessation)
Phase 2b multi-site placebo-controlled trial; PI: Dr. Matthew Johnson (Johns Hopkins); sites: Hopkins, NYU, UAB; IND filed with FDA
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Phase II topline
Programme phase
NRCx-201 Phase 2 Programme (Bipolar Depression / TRD) — Wellcome Trust Funded
Wellcome-backed Phase 2 bipolar-depression study NCT07644767 is registered but not yet recruiting. The registry lists 160 estimated participants, estimated start on 2026-10-30, primary completion in January 2028, and last update posted 2026-06-12. The September 2025 Wellcome funding release remains the key financing source.
View profile contextcompany-website · Neurocentrx · Jun 26, 2026 · Verified
Milestone: Phase II started · actual Jan 1, 2026
11 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Programme phase
MSP-1014 Adaptive Phase 2a/2b (MDD, SSRI Non-Responders) — MHRA/UK
Adaptive Phase 2a/2b at Clerkenwell Health, UK (~70 patients). Part 1: open-label dose escalation 30/50/70mg (n~10). Part 2: double-blind RCT vs placebo (n~60). MHRA approved June 2023. Data readout not yet reported (study period reportedly ended Oct 2024).
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
5 sources
0 trials · 0 papers
Phase II topline
Programme phase
Ketamine Phase 2 Programme (Parkinson's / LID) — NCT04912115
Phase 2 complete (suspended before planned March 2024 completion); positive results — subanesthetic IV ketamine reduced LID; advancing toward Phase 3, seeking partnership
View profile contextPress release · PharmaTher · Jan 1, 2026 · Verified
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
NPX-5 Phase IIb Programme (Adjustment Disorder, Palliative Care) — ANZCTR 12624000449538p
Phase IIb active in Australia (TGA); 87 participants; 3 sites operational (Perth, Melbourne ×2); patient dosing underway; GMP NPX-5 exported from Canada to Australia confirmed March 2026; topline results expected end of 2026
View profile contextRegulatory filing · SEC / Psyence BioMed · Apr 23, 2026 · Verified
Milestone: Trial start · actual Jan 1, 2025
6 sources
0 trials · 0 papers
Phase II topline
Programme phase
RE03 — Phase 2a Insomnia in PTSD (NCT06685965)
RE03 Phase 2a is recruiting in PTSD-related sleep disturbance. Reconnect announced first patient enrollment on 2025-10-20, and ClinicalTrials.gov lists estimated study completion in August 2026.
View profile contextcompany-website · Reconnect Labs · Jun 26, 2026 · Verified
Milestone: Trial start · actual Jun 1, 2025
8 sources
0 trials · 0 papers
Phase II topline · likely Q4 2026
Programme phase
RSTP1000 Phase 2b Programme (Demoralization in Cancer)
FDA IND cleared November 2023 ("Safe to Proceed"); Phase 2b multicenter, randomized, dose-ranging, double-blind, parallel-group study; likely in site activation/early enrollment; quiet since IND clearance
View profile contextcompany-website · Reset Pharma · Jun 26, 2026 · Verified
Milestone: Funding milestone · actual Jun 1, 2022
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
RECLAIM — RE104 GAD Phase 2
RECLAIM Phase 2 is recruiting for generalized anxiety disorder. ClinicalTrials.gov lists an actual study start in April 2026 and an estimated primary completion in February 2027; Reunion expects clinical data in Q2 2027.
View profile contextclinical-trial-registry · ClinicalTrials.gov · Jun 26, 2026 · Verified
Milestone: Phase II started
5 sources
0 trials · 0 papers
Phase II topline · likely Q2 2027
Programme phase
REKINDLE — RE104 Adjustment Disorder Phase 2
REKINDLE Phase 2 is recruiting in adjustment disorder related to cancer and other medical illnesses. ClinicalTrials.gov lists estimated primary completion in November 2026, and Reunion has guided to topline results in 2027.
View profile contextclinical-trial-registry · ClinicalTrials.gov · Jun 3, 2026 · Verified
2 sources
0 trials · 0 papers
Phase II topline · likely Q1 2027
Programme phase
GlyphAllo BUOY-1 Phase 2b Programme (MDD)
BUOY-1 Phase 2b enrolling (NCT07065240); ~360 participants; 6-week HAMD-17 primary endpoint
View profile contextPress release · BioSpace / Seaport Therapeutics · Jun 12, 2026 · Verified
7 sources
0 trials · 0 papers
Phase II topline
Programme phase
SVN-002 Phase 2b Programme (AUD, US 505(b)(2))
Solvonis reported positive SVN-002 PK bridging data on 2026-06-22. Next steps are FDA feedback on toxicology/CMC, then IND submission to start a US Phase 2b AUD study under a planned 505(b)(2) pathway referencing Spravato.
View profile contextcompany-website · Solvonis Therapeutics · Jun 27, 2026 · Verified
Milestone: Regulatory review accepted · actual Dec 1, 2024
7 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Eventual approval estimate: 25%
Programme phase
CMND-100 Phase I/IIa Programme (AUD) — Yale/JHU/Tel Aviv
Phase I/IIa multinational trial active; Cohorts 1 and 2 completed (12 patients, no SAEs); Cohort 3 recruiting at 80mg dose escalation (Yale, JHU, Tel Aviv Sourasky); DSMB cleared dose escalation March 2026
View profile contextPress release · Clearmind Medicine · Jun 16, 2026 · Verified
Milestone: Efficacy data · actual Nov 24, 2025
15 sources
0 trials · 0 papers
Forecast saved
Programme phase
AP-188 Programme (Stroke/TBI) — Algernon NeuroScience subsidiary
Phase 1 DMT study NCT05559931 is registry-listed as active, not recruiting, with last update posted 2025-01-28 and estimated completion in March 2026. PubMed-indexed 2025 Phase 1 publication supports safety/PK/PD for the 6-hour IV infusion. No public source found confirming Phase 2 stroke/TBI start as of the June 2026 sweep; corporate news indicates the programme now sits inside a Grey Matters/NovaScan diagnostics pivot.
View profile contextcompany-website · Algernon NeuroScience · Jun 27, 2026 · Verified
13 sources
0 trials · 0 papers
Forecast saved
Programme phase
AM-1002 — Phase 1 First-in-Human (GAD)
FDA IND cleared October 6, 2025. Phase 1 first-in-human trial planned. No NCT number posted or first-patient-dosed announcement as of April 2026. Gary Riordan (former FDA primary reviewer) leads regulatory.
View profile contextindustry-media · Psychedelic Health · Oct 15, 2025 · Verified
Milestone: regulatory-milestone · actual Oct 6, 2025
8 sources
0 trials · 0 papers
Phase I topline
Programme phase
NYPRG-101 Phase 1 Programme (Migraine Prevention)
IND submitted for NYPRG-101 migraine prevention in June 2022 and first participant dosed in Phase 1 in January 2023; no newer public trial registry or company status update found in this pass.
View profile contextcompany-website · Ceruvia Lifesciences · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
programme-status-update
Programme phase
CLE-905 Phase 1 Programme (Schizophrenia) — Syremis spinout
Licensed/spun out to Syremis Therapeutics. Fierce Biotech reported Syremis launched on 2025-12-18 with a $165M Series A and ST-905/CLE-905 in Phase 1 development for schizophrenia and other neuropsychiatric conditions; Syremis also lists ST-905 as a potent M1/M4 preferential muscarinic agonist.
View profile contextNews / media · Fierce Biotech · Dec 18, 2025 · Verified
Milestone: Licensing deal · actual Jun 1, 2024
3 sources
0 trials · 0 papers
Phase I topline · likely Q4 2026
DMX-1001 Programme (AUD) — Neuroplastogen / GDNF Enhancer
Phase 1 MAD trial completed in 55 healthy volunteers (NCT06480981), with January 2026 safety/tolerability/PK results supporting Phase 2 development. FDA accepted the DMX-1001 IND for AUD in April 2026; DemeRx says an alcohol-interaction trial will support Phase 2 start in 2027.
View profile contextgrant-database · NIH RePORTER · Jun 27, 2026 · Verified
8 sources
0 trials · 0 papers
Forecast saved
Programme phase
GH002 — Phase 1 Healthy Volunteers
GH002 Phase 1 healthy-volunteer study is complete. GH Research clinical-trials materials describe the IV mebufotenin study as n=64 with no severe or serious adverse events, and the FY2025 update continues to list GH002 as an IV mebufotenin product candidate. No patient-indication next step has been publicly announced.
View profile contextcompany-website · GH Research · Jun 27, 2026 · Verified
4 sources
1 trials · 0 papers
No forecast saved
Programme phase
L-130 Programme (Cluster Headache / OUD) — via Cynaptec Pharmaceuticals
Phase 1 NCT06035900 is completed and a 2024 publication reports first-in-human pharmacokinetic data. Lobe reported on 2026-05-06 that R&D spend increased primarily from advancement of Cynaptec Pharmaceuticals L-130 work; no public Phase 2 start was found in this pass.
View profile contextPress release · Lobe Sciences / ACCESS Newswire · May 6, 2026 · Verified
Milestone: Company milestone · actual Sep 9, 2025
15 sources
0 trials · 0 papers
Phase II started · likely Q1 2027
Programme phase
LPH-5 Phase I Programme (TRD/MDD) — EMA-authorised
Lophora dosed first subjects in Phase 1 in May 2025 and reported positive Phase 1 topline results for LPH-5 on June 10, 2026; the company now describes LPH-5 as entering Phase Ib.
View profile contextPress release · Lophora · Jun 10, 2026 · Verified
9 sources
0 trials · 0 papers
Phase II started
Programme phase
MSP-2020 Phase 1 Programme (MDD) — Otsuka lead neuroplastogen
MSP-2020 is listed in Otsuka's Mar. 31, 2026 pipeline as an oral Phase I psychiatry/neurology programme. A recruiting Phase 1 PET/brain-imaging study, NCT07329621, began in January 2026.
View profile contextclinical-trial-registry · ClinicalTrials.gov · Jun 12, 2026 · Verified
5 sources
0 trials · 0 papers
Forecast saved
Programme phase
MSD-001 Phase 1 Programme (Mood/Anxiety) — CHDR Netherlands
MSD-001 Phase 1 SAD study NCT06702332 is completed. Mindstate announced topline results on 2025-09-24: MSD-001 was safe and well tolerated, showed dose-proportional linear PK, produced narrowly defined psychoactive effects without hallucinations, and will primarily serve as a base compound for fixed-dose combinations. The next watch item is initiation or registration of a fixed-dose combination Phase 1 study.
View profile contextcompany-website · Mindstate Design Labs · Jun 26, 2026 · Verified
Milestone: Funding milestone · actual Feb 1, 2022
10 sources
0 trials · 0 papers
Phase I started · likely Q1 2027
Programme phase
MLS101 Phase 1 Programme (SAD/MAD/Neuroimaging) — Australia
Three MLS101 Phase 1 studies are completed on ClinicalTrials.gov, including the fMRI/translational study NCT07050368 with actual completion on 2026-01-13 and last update posted 2026-02-13. No public Phase 1 data package or Phase 2 start was found in this pass.
View profile contextcompany-website · MycoMedica Life Sciences · Jun 27, 2026 · Verified
11 sources
0 trials · 0 papers
Phase I publication · likely Q4 2026
Programme phase
NBX-100 (1st gen) — Phase 1 PoC (St Vincent's Melbourne)
Completed. Phase 1 proof-of-concept with first-generation DMT-harmala formulation. Results published in Scientific Reports (Nature Portfolio) early 2025.
View profile contextcompany-website · Neurala Biosciences · Jun 27, 2026 · Verified
6 sources
0 trials · 0 papers
No forecast saved
Programme phase
NBX-100 (2nd gen) — Phase 1 PK/PD (CMAX Adelaide)
HREC and TGA regulatory approvals granted. GMP drug product final release testing completed Jan 2026. All clinical and CRO contracts in place. Phase 1 PK/PD study at CMAX Clinical Research (Adelaide) commencing. Second-generation formulation with proprietary harmala alkaloid refinements.
View profile contextcompany-website · Neurala Biosciences · Jun 27, 2026 · Verified
7 sources
0 trials · 0 papers
Phase II started
Programme phase
RE01 — Phase 1 Safety & PK (Cocaine/Stimulant SUD)
Phase 1 studies NCT04716335 and NCT05829603 are complete, with peer-reviewed DMT/harmine formulation data published. Reconnect still lists RE01 for cocaine and stimulant use disorder, and a March 2026 company release highlighted RE01 as a controllable, scalable psychedelic architecture.
View profile contextcompany-website · Reconnect Labs · Jun 27, 2026 · Verified
8 sources
0 trials · 0 papers
Phase II started · likely Q1 2027
Programme phase
RE02 — Phase 1 (Treatment-Resistant GAD)
The Phase 1 RE02 registry remains listed as terminated after 4 participants. Reconnect's current pipeline still describes RE02 as a rapid-acting, non-addictive anxiolytic for treatment-resistant GAD, so the next action is company clarification of Phase 1 outcome and Phase 2a timing.
View profile contextcompany-website · Reconnect Labs · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Phase II started · likely Q2 2027
Programme phase
Whole Mushroom Psilocybin Phase 1/2 PTSD (NCT07275970) — FDA Authorized
Recruiting Phase 1 trial NCT07275970 is listed with a February 2026 start for whole psilocybin-containing mushrooms in adults with PTSD. Recent reporting says Arizona funding and first-responder interest are supporting the study.
View profile contextnews · InvestigateTV · Apr 24, 2026 · Verified
Milestone: Phase I started · actual Dec 1, 2025
8 sources
0 trials · 0 papers
Phase I topline
Programme phase
GlyphAgo Phase 1 Programme (GAD/MDD)
Phase 1 GlyphAgo/SPT-320 trial has positive SAD, crossover, and MAD data reported through June 2026. Seaport plans a Phase 2a GAD trial in H2 2026 and a Phase 2b GAD trial in H1 2027.
View profile contextclinical-trial-registry · ANZCTR · Jun 26, 2026 · Verified
Milestone: Phase I started · actual Sep 1, 2025
9 sources
0 trials · 0 papers
Phase II started
Programme phase
Idazoxan XR — Phase 1 PK/Safety (NCT05727189)
Idazoxan XR Phase 1 study NCT05727189 is active, not recruiting. ClinicalTrials.gov lists 150 estimated participants, multiple extended-release idazoxan formulations, and estimated primary/completion dates in December 2027.
View profile contextcompany-website · Terran Biosciences · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Phase I completed · likely Q4 2027
Programme phase
SAI NCE — IND-Enabling Ophthalmology Nerve Regeneration
IND-enabling studies underway (as of August 2025). Human clinical trials targeted for November 2026. Preclinical programme demonstrated corneal nerve regeneration, RGC protection in glaucoma, and resolution of ocular inflammation in animal models.
View profile contextindustry-media · Pitch.vc · Jun 27, 2026 · Verified
Milestone: data-readout · actual Nov 1, 2024
6 sources
0 trials · 0 papers
Forecast saved
Programme phase
GM-5022 / AbbVie-Partnered Neuroplastogens - Depression & Anxiety
Preclinical AbbVie-partnered neuroplastogen programme. AbbVie/Gilgamesh collaboration remains active after AbbVie acquired only bretisilocin; Gilgamesh now presents the class as non-hallucinogenic Neuroplastogens for depression and anxiety.
View profile contextcompany-website · Gilgamesh Pharma · Jun 26, 2026 · Verified
6 sources
0 trials · 0 papers
Preclinical completed
Programme phase
ASR-2001 Preclinical Programme
Preclinical phenylalkylamine work remains supported by ASRI 2024 patent filings and news updates; no clinical trial registration was found in this pass.
View profile contextcompany-website · Alexander Shulgin Research Institute · Jun 26, 2026 · Verified
2 sources
0 trials · 0 papers
preclinical-data
Programme phase
ASR-3001 IND-Enabling Programme (Depression/Anxiety)
ASRI continues to describe ASR-3001 as its advanced tryptamine candidate, supported by 2024 patent filings. No public IND filing was found in this pass.
View profile contextcompany-website · Alexander Shulgin Research Institute · Jun 27, 2026 · Verified
Milestone: Funding milestone · actual Dec 9, 2021
9 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
5-MeO-DMT Preclinical Programme (SUD) — UCD Dublin collaboration
Alvarius still presents a 5-MeO-DMT substance-use programme and planned Phase 1 safety work on its website, but no public clinical trial registration or Phase 1 start confirmation was found in this pass.
View profile contextcompany-website · Alvarius Pharmaceuticals · Jun 26, 2026 · Verified
Milestone: preclinical-data · actual Jun 1, 2023
9 sources
0 trials · 0 papers
Forecast saved
Programme phase
AM-1004 — Preclinical MDD
Preclinical/discovery. Arcadia lists AM-1004 for MDD as a short-acting psychoactive-empathogen combination therapy; no IND or clinical trial has been announced as of June 2026.
View profile contextcompany-website · Arcadia Medicine · Jun 26, 2026 · Verified
Milestone: Preclinical started · actual Oct 6, 2025
4 sources
0 trials · 0 papers
Preclinical completed
Programme phase
AM-1006 — Preclinical SUD
Preclinical/discovery. Arcadia lists AM-1006 for substance use disorder/substance abuse as a short-acting subperceptual psychoactive drug intended for hour-long therapeutic settings.
View profile contextcompany-website · Arcadia Medicine · Jun 26, 2026 · Verified
Milestone: Preclinical started · actual Oct 6, 2025
4 sources
0 trials · 0 papers
Preclinical completed
Programme phase
BETR-001 IND-Enabling Programme (MDD/Anxiety/Cluster Headache)
BETR-001 remains in final IND-enabling development. BetterLife closed CAD $2M financing on 2026-06-22 to fund remaining FDA IND work, then engaged Syner-G on 2026-06-25 to oversee GMP manufacturing for the planned IND and Phase 1 programme. The initial clinical focus has shifted to chronic cluster headache and chronic migraine, with IND filing and Phase 1 start projected for Q1 2027.
View profile contextPress release · BetterLife Pharma / Newsfile · Jun 25, 2026 · Verified
Milestone: Company milestone · actual Jan 1, 2025
10 sources
0 trials · 0 papers
Regulatory filing submitted · likely Q1 2027
Programme phase
BMND06 Preclinical Programme (Obesity via Neurological Pathway)
BMND06 remains publicly positioned for obesity through neurological pathways, based on Biomind's July 2024 update and current company pipeline language.
View profile contextcompany-website · Biomind Labs · Jun 26, 2026 · Verified
Milestone: Preclinical completed · actual Jul 1, 2024
4 sources
0 trials · 0 papers
preclinical-data
Programme phase
BMB-201 — Headache/Pain Preclinical
Positive preclinical pain and vascular-headache data support advancement toward clinical development. No IND filing or human-study start was found in the June 2026 sweep, so the next watch item remains additional preclinical/IND-enabling disclosure or a clinical-trial start announcement.
View profile contextcompany-website · Bright Minds Biosciences · Jun 26, 2026 · Verified
2 sources
0 trials · 0 papers
preclinical-data
Programme phase
BMB-202 — Preclinical Depression
Preclinical 5-HT2A agonist for depression. Bright Minds’ recent communications emphasize BMB-101 and BMB-201; no clinical-stage BMB-202 update was found in June 2026 checks.
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
3 sources
0 trials · 0 papers
Preclinical completed
Programme phase
CT-4201 IND-Enabling Programme (MDD)
CT-4201 remains preclinical/IND-enabling; CaaMTech reported FDA feedback in November 2024 validating its functional-unblinding strategy for future MDD trials.
View profile contextcompany-website · CaaMTech · Jun 26, 2026 · Verified
Milestone: Company milestone · actual Apr 22, 2025
9 sources
0 trials · 0 papers
Phase I started
Programme phase
DLX-159 Preclinical Programme
DLX-159 remains a preclinical Delix developmental candidate; Delix presented preclinical findings at ACNP 2024 and described it as orally bioavailable and non-hallucinogenic.
View profile contextcompany-website · Delix Therapeutics · Jun 26, 2026 · Verified
2 sources
0 trials · 0 papers
preclinical-data
Programme phase
MDMA Analogue Library Preclinical Programme (UWA, 150+ compounds)
UWA/Emyria MDMA-analogue programme remains preclinical, with UWA 2025 award coverage confirming Emyria rights to the analogue library and initial Parkinson disease focus.
View profile contextuniversity-news · University of Western Australia · Nov 1, 2025 · Verified
2 sources
0 trials · 0 papers
Forecast saved
Programme phase
EB-003 IND-Enabling Programme (PTSD/MDD)
EB-003 remains in 2026 IND preparation after Enveric completed dose-range studies and received FDA pre-IND feedback in 2025; first-in-human Phase 1 planning continues.
View profile contextPress release · BioSpace · Mar 30, 2026 · Verified
Milestone: Company milestone · actual Sep 2, 2025
14 sources
0 trials · 0 papers
Forecast saved
Programme phase
EQL-101 — IND-Enabling Studies (OUD/SUD)
IND-enabling studies underway. First-in-human dosing targeted for Q4 2026. NIDA-funded preclinical work at RTI International confirms anti-addictive efficacy comparable to ibogaine in animal models. Transdiagnostic regulatory strategy targeting multiple indications.
View profile contextindustry-media · Drug Discovery Online · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
GM-3009 IND-Enabling Programme (OUD/PTSD/TBI)
GM-3009 remains an active preclinical/IND-enabling ibogaine-analogue programme supported by the 14M NIDA grant; Gilgamesh reported in 2026 that Phase 1 entry is expected later this year.
View profile contextcompany-website · Gilgamesh Pharma · Jun 27, 2026 · Verified
5 sources
0 trials · 0 papers
Forecast saved
Programme phase
GM-5022 Preclinical Programme
GM-5022 remains a preclinical Gilgamesh programme listed on the company pipeline; recent 2026 financing supports continued development of retained pipeline assets.
View profile contextcompany-website · Gilgamesh Pharma · Jun 27, 2026 · Verified
2 sources
0 trials · 0 papers
preclinical-data
Programme phase
M1/M4 Muscarinic Agonist Preclinical Programme (Schizophrenia)
Gilgamesh continues to list an M1/M4 muscarinic agonist programme for schizophrenia; no clinical-stage registration was found in this pass.
View profile contextcompany-website · Gilgamesh Pharma · Jun 27, 2026 · Verified
2 sources
0 trials · 0 papers
Forecast saved
Programme phase
JOUR-5700 Programme (AUD) — Pre-Phase 1
JOUR-5700 remains a preclinical mescaline HCl AUD programme in public databases and historical company coverage; no ClinicalTrials.gov registration or recent Journey Colab clinical-start update was found in this pass.
View profile contextdrug-database · AdisInsight · Jun 26, 2026 · Verified
Milestone: Company milestone · actual Dec 1, 2023
9 sources
0 trials · 0 papers
Phase I started
Programme phase
KB-128 IND-Enabling Programme (AUD) — Trifunctional 5-HT2C Agonist / 2A+2B Antagonist
KB-128 remains in IND-enabling/preclinical development for AUD, backed by a 2M NIAAA grant announced in September 2025.
View profile contextcompany-website · Kuleon Bioscience · Jun 26, 2026 · Verified
Milestone: preclinical-data · actual Jun 1, 2024
8 sources
0 trials · 0 papers
Phase I started
Programme phase
LPH-48 Preclinical Programme
LPH-48 remains a preclinical fast-follower to LPH-5, described by Lophora as a short-duration candidate with similar primary pharmacology. Lophora reported positive Phase 1 topline results for lead candidate LPH-5 on 2026-06-10, supporting continued platform development and Phase Ib entry for LPH-5.
View profile contextPress release · Lophora · Jun 10, 2026 · Verified
3 sources
0 trials · 0 papers
preclinical-data · likely Q1 2027
Programme phase
MB-204 Programme (Rett Syndrome / Fragile X) — Phase 1 imminent
MB-204 is moving toward Phase 1: Marvel selected Novotech as CRO in March 2026 after cGMP synthesis and GLP toxicology, while continuing Rett and Fragile X preclinical positioning.
View profile contextPress release · BioSpace · Mar 30, 2026 · Verified
Milestone: Funding milestone · actual Mar 30, 2026
10 sources
0 trials · 0 papers
Forecast saved
Programme phase
MYCO-004 Preclinical Programme (Transdermal Tryptamine, SUD)
MYCO-004 remains supported mainly by 2021 Mydecine disclosures as a patch-delivered tryptamine for SUD/smoking cessation. Mydecine changed its public company name to Noveris Health Sciences in February 2026; no recent MYCO-004 clinical-start confirmation was found.
View profile contextexchange-notice · Canadian Securities Exchange / Newsfile · Feb 2, 2026 · Verified
3 sources
0 trials · 0 papers
Forecast saved
Programme phase
NBX-200 — GMP Formulation Development (Ab Initio Pharma)
NBX-200 advanced in early 2026 with Neurala reporting Phase 1 data for second-generation DMT-harmala candidates; GMP formulation and manufacturing work for NBX-200 is underway with Ab Initio Pharma.
View profile contextcompany-website · Neurala Biosciences · Jun 27, 2026 · Verified
4 sources
0 trials · 0 papers
Forecast saved
Programme phase
Ariadne (4C-D) — Parkinson's Apathy (Ariadne Bio)
Phase 1b study in Parkinson's apathy was planned for H1 2025 — launch not publicly confirmed. Developed through subsidiary Ariadne Bio (CEO: Shlomi Raz, ex-Goldman Sachs MD, founder of Eleusis, ex-President Beckley Psytech).
View profile contextcompany-website · Negev Labs · Jun 26, 2026 · Verified
3 sources
0 trials · 0 papers
Phase I started
Programme phase
Athena — Prader-Willi Aggression / ADHD Impulsivity
Athena remains an early/preclinical Palomar Labs programme; public support is thin, with investor-profile materials describing Athena Neurosciences for ADHD and the former Negev Labs site describing the broader venture-building model.
View profile contextcompany-website · Negev Labs · Jun 26, 2026 · Verified
2 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
ELE-02 — Retinal Degeneration (Ophthalmology)
ELE-02/ophthalmology neuroplastogen programme remains preclinical after Negev acquired the Beckley Psytech ophthalmology programme in late 2024; no IND filing was found in this pass.
View profile contextcompany-website · Negev Labs · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
HBL20017 — OCD / Tic Disorders (Hadassah BrainLabs)
Preclinical completed with remarkable single-dose durability. No IND filed. Developed in collaboration with Hadassah BrainLabs Center for Psychedelic Research (Prof. Bernard Lerer) and synthesized by Pharmaron Inc.
View profile contextpeer-reviewed · International Journal of Neuropsychopharmacology · Aug 1, 2025 · Verified
Milestone: Efficacy data · actual Aug 1, 2025
2 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
ALA-002 — Phase 2a/2b Social Anxiety in ASD (University of Sydney)
Phase 2a/2b preparation. UK-based CDMO contracted December 2025 for drug substance manufacture. ALA-002 capsule encapsulation on production schedule. Phase 2 protocol completed with University of Sydney (Dr. Adam Guastella, Michael Crouch Chair in Child and Youth Mental Health). Trial expected to initiate 2026 in Australia. No CTA/TGA approval yet announced.
View profile contextPress release · GlobeNewswire · Dec 15, 2025 · Verified
Milestone: Company milestone · actual Dec 15, 2025
6 sources
0 trials · 0 papers
Phase II started
Programme phase
APA-001 — Preclinical Development (Trauma/TBI/Neurological)
APA-01 is being advanced through Restora Neurosciences after a 2026 definitive SPV agreement, with the stated objective of a first FDA IND; preclinical proof-of-concept and patent evidence remain the core support.
View profile contextPress release · BioSpace / PharmAla Biotech · May 1, 2026 · Verified
5 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
AUD Neuroplastogen — NIH/NIAAA-funded IND-enabling
NIH/NIAAA SBIR grant-funded IND-enabling studies. Targeting serotonergic and glutaminergic pathways in AUD. Initial preclinical safety and toxicity assessments passed.
View profile contextPress release · BioSpace · Oct 3, 2025 · Verified
Milestone: Funding milestone · actual Oct 3, 2025
2 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
PSIL-006 — IND-enabling bvFTD
Late IND-enabling. May 2026 seed financing is intended to advance PSIL-006 toward first-in-human trials in 2027.
View profile contextcompany-website · Psilera · Jun 27, 2026 · Verified
12 sources
0 trials · 0 papers
Phase I started · likely Q2 2027
Programme phase
PSIL-025 — Preclinical Anxiety
Preclinical non-hallucinogenic candidate for anxiety disorders. Public detail remains sparse, and Psilera’s 2026 financing/news emphasizes PSIL-006 as lead asset.
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
Milestone: Preclinical started · actual May 17, 2024
4 sources
0 trials · 0 papers
Preclinical completed
Programme phase
PSY-05 — Preclinical (GAD / PTSD)
Public sources conflict on naming: Psy March 2025 highlights use PSY-05 for an oral pain/PTSD programme entering IND-enabling, whereas the current Psy site lists PSY-05001 for pain/PTSD and does not list a separate PSY-05. Synapse tracks PSY-05 as pending/preclinical. Keep this record visible as a mapping-cleanup and waiting-on-news item.
View profile contextdrug-database · Synapse / PatSnap · Jun 26, 2026 · Verified
3 sources
0 trials · 0 papers
programme-status-update
Programme phase
PSY-05001 — IND-Enabling (Chronic Pain / PTSD Sleep)
IND-enabling studies in progress. Lead optimization completed. Preclinical efficacy confirmed in neuropathic, inflammatory, and post-operative pain models (Mar 2025). US composition of matter patent allowed through 2042. Company raising $10M convertible note to advance into Phase 1 FIH study and enable Series A.
View profile contextcompany-website · Psy Therapeutics · Jun 26, 2026 · Verified
Milestone: ip-milestone · actual Jun 1, 2024
4 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
Natural Psilocybin R&D Programme (Irvine Labs + Filament Health acquisition)
Red Light completed the Filament Health acquisition on April 30, 2026, adding botanical psilocybin IP, GMP manufacturing, and clinical authorization assets; Irvine Labs import activity remains relevant to natural psilocybin R&D.
View profile contextPress release · Yahoo Finance / Red Light Holland · May 1, 2026 · Verified
7 sources
0 trials · 0 papers
Forecast saved
Programme phase
CX157 + DMT — Preclinical Development
Preclinical platform development. No IND filed for the CX157+DMT combination. CX157 previously had an FDA IND (approved Jan 2007 under CeNeRx) but status unclear after 2013 development termination. Patent WO2024108195A1 filed Nov 2023 covering CX157 + tryptamine combinations. Company seeks partnerships and collaborations.
View profile contextcompany-website · Remedi Therapeutics · Jun 26, 2026 · Verified
9 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
RE245 — Preclinical / IND-Enabling
RE245 remains Reunion's lead non-psychedelic discovery-stage 5-HT2A agonist. Reunion reiterated in February, May, and June 2026 that it plans to file an IND in 2026; no IND submission or clearance announcement was found in this pass.
View profile contextcompany-website · Reunion Neuroscience · Jun 27, 2026 · Verified
4 sources
0 trials · 0 papers
Regulatory filing submitted · likely Q4 2026
Programme phase
Bucillamine — Nerve Agent Countermeasure (DRDC)
Research study with Defence R&D Canada (DRDC) — Suffield Research Centre nearing completion (targeted Sep 2025). Bucillamine for nerve agent-induced brain injury (sarin, soman, tabun, VX). Health Canada approval for strategic stockpiling targeted 2026. Five Eyes procurement opportunity (Canada, US, UK, Australia, NZ).
View profile contextcompany-website · Revive Therapeutics · Jun 27, 2026 · Verified
2 sources
0 trials · 0 papers
Forecast saved
Programme phase
Bucillamine — Phase 2 Long COVID
Phase 2 Long COVID study planned. FDA Type C meeting (Jun 2024) recommended new IND with cross-reference to prior COVID-19 IND (NCT04504734, Phase 3, terminated by DSMB). IND submission targeted Q1 2025; FDA approval of protocol expected Q2 2025. No confirmation IND has been filed. Extremely limited cash ($14,560 as of Jun 2025).
View profile contextcompany-website · Revive Therapeutics · Jun 27, 2026 · Verified
4 sources
0 trials · 0 papers
Phase II started
Programme phase
SPT-348 Preclinical Programme (Cluster Headache/TRD)
SPT-348/Glyph2BLSD remains preclinical; Seaport's June 2026 SEC update says first-in-human-enabling studies are expected by year-end 2027.
View profile contextcompany-website · Seaport Therapeutics · Jun 27, 2026 · Verified
3 sources
0 trials · 0 papers
Forecast saved
Programme phase
Psilocybin + Beta-Carboline Buccal Film — Feasibility Study (Anorexia Nervosa)
Shortwave continues to position its psilocybin buccal film around an anorexia feasibility study; 2025 coverage says the company is working to show safe delivery and clinical-practice integration.
View profile contextindustry-media · Psychedelic Health · Dec 10, 2025 · Verified
Milestone: Company milestone · actual Dec 4, 2025
9 sources
0 trials · 0 papers
preclinical-data
Programme phase
SP-26 Preclinical Programme (Fibromyalgia / Chronic Pain) — Ketamine Implant
SP-26 remains a preclinical ketamine-loaded implant programme for fibromyalgia/chronic pain, with 2025 minipig endpoint data and Sever Pharma scale-up work.
View profile contextpartner-announcement · Sever Pharma Solutions · Aug 14, 2025 · Verified
5 sources
0 trials · 0 papers
preclinical-data
Programme phase
SPC-15 IND-Enabling Programme (PTSD) — Columbia University licence
SPC-15 remains in IND-enabling work for PTSD/stress-induced anxiety, with GLP safety work at Frontage and public 2025 plans for IND submission and potential 2026 Phase 1.
View profile contextindustry-media · Quiver Quantitative · Jul 1, 2025 · Verified
8 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
SVN-015 Preclinical Programme (Stimulant Addiction, NIDA-funded)
SVN-015 was accepted into the NIDA Addiction Treatment Discovery Program on 2025-12-03 for methamphetamine and cocaine addiction. NIDA support covers cardio-risk and preclinical efficacy studies; the next watch item is 2026 preclinical readout or IND-enabling guidance.
View profile contextPress release · Solvonis Therapeutics · Dec 3, 2025 · Verified
Milestone: Funding milestone · actual Dec 1, 2025
2 sources
0 trials · 0 papers
preclinical-data · likely Q4 2026
Programme phase
SVN-SDN-14 Preclinical Programme (PTSD)
SVN-SDN-14 has produced positive preclinical PTSD data, and Solvonis selected SVN-114 as the lead candidate from the series in 2026.
View profile contextcompany-website · Solvonis Therapeutics · Jun 27, 2026 · Verified
3 sources
0 trials · 0 papers
Forecast saved
Programme phase
SON-001 — TBI / Neuropsychiatric Development
Pre-clinical stage. No Soneira-sponsored clinical trial registered on ClinicalTrials.gov. No IND filing or FDA pre-IND meeting publicly disclosed. Stanford MISTIC study (NCT04313712, observational, NOT FDA-regulated) provides foundational clinical data. Two patent applications filed jointly with Stanford (Sep 2023). Company path forward unclear after loss of founding advisor Nolan Williams (Oct 2025).
View profile contextPress release · Stanford Medicine · Dec 1, 2025 · Verified
Milestone: Company milestone · actual Oct 8, 2025
9 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
Novel Benzofuran Entactogen Library Preclinical Programme
TACT833/411/523 remains a preclinical Tactogen entactogen programme. Public evidence is mostly undated company pipeline language, older patent applications, and drug-database tracking; no fresh trial, IND, financing, or candidate-selection update was found in the June 2026 sweep. Keep as waiting-on-news.
View profile contextdrug-database · PatSnap Synapse · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
preclinical-data
Programme phase
TACT908 Preclinical Programme (Cluster Headache)
TACT908 remains a preclinical cluster-headache programme, supported by Tactogen pipeline/patent material and drug-database tracking.
View profile contextdrug-database · PatSnap Synapse · Jun 26, 2026 · Verified
3 sources
0 trials · 0 papers
Forecast saved
Programme phase
R-192 Norketamine Programme (MDD) — Phase 1 PK Study
R-192 remains clinically ready/preclinical, with public reporting expecting a Phase 1 PK study in H2 2026 and Tasman continuing oral ketamine/norketamine development activity.
View profile contextcompany-website · Tasman Therapeutics · Jun 27, 2026 · Verified
3 sources
0 trials · 0 papers
Forecast saved
Eplivanserin + Volinanserin (5-HT2A Antagonist Psychedelic Combos)
Compound not specified
Programme phase
Psychedelic + 5-HT2A Antagonist Combinations
Preclinical combo development. Eplivanserin and volinanserin have extensive Phase 3 safety databases (15,000+ patients). Exclusive license from University of Maryland Baltimore (Mar 2022) for psilocybin + 5-HT2A antagonist combination patents and data. 200+ patent applications across 30+ families covering prodrugs of psilocin, LSD, 2C-B, methylone, long-acting MDMA, oral DMT, 5-MeO-DMT.
View profile contextcompany-website · Terran Biosciences · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
TerXT — Phase 1 PK Bridging (Schizophrenia, 505(b)(2))
TerXT remains a non-psychedelic schizophrenia prodrug programme; Terran continues to position it for 505(b)(2)-style development, with PK bridging expected around the Cobenfy/KarXT regulatory window.
View profile contextcompany-website · Terran Biosciences · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
TN-001 — IND-enabling MDD/PTSD
IND-enabling studies. ACNP 2026 preclinical data presented. CEO Lykins states wrapping up preclinical efforts and progressing into clinical trials. IND filing timeline not publicly disclosed.
View profile contextcompany-website · Transneural Therapeutics · Jun 27, 2026 · Verified
6 sources
0 trials · 0 papers
Regulatory filing submitted
Programme phase
MEO201 — 5-MeO-DMT Phase 2 Preparation
Usona reports completed CMC, manufacturing, protocol, vendor-selection, and study start-up work positioning MEO201 to move into Phase 2 efficacy studies. No public Phase 2 launch registration or first-patient announcement was found in the June 2026 sweep, so this remains a waiting-on-news Phase 2-start watch item.
View profile contextcompany-website · Usona Institute · Jun 26, 2026 · Verified
Milestone: Preclinical completed · actual Dec 1, 2024
5 sources
0 trials · 0 papers
Phase II started · likely Q4 2026
Programme phase
XYL-1001 IND-Enabling Programme (Depression/Anxiety)
XYL-1001 remains in IND-enabling/manufacturing scale-up, with Xylo reporting rebrand/pipeline progress in 2025 and first-in-human trials planned around mid-2026.
View profile contextcompany-website · Xylo Bio · Jun 26, 2026 · Verified
9 sources
0 trials · 0 papers
Forecast saved
Programme phase
SAI Anti-Inflammatory Platform - CNS/Systemic Discovery
Discovery-stage serotonergic anti-inflammatory platform extending 5-HT2A precision agonism beyond the ophthalmology lead into CNS neurodegeneration and systemic inflammatory indications. Company site says 2A is in stealth and preparing for clinical study initiation, but no platform-specific IND or trial has been announced.
View profile contextcompany-website · 2A Biosciences · Jun 26, 2026 · Verified
Milestone: Discovery started
3 sources
0 trials · 0 papers
Preclinical started
Programme phase
XOB Discovery Programme (Bipolar Disorder)
XOB remains a discovery-stage bipolar disorder programme, supported by ASRI 2024 announcement and peer-reviewed pharmacology characterisation.
View profile contextcompany-website · Alexander Shulgin Research Institute · Jun 26, 2026 · Verified
Milestone: Discovery started · actual May 1, 2024
5 sources
0 trials · 0 papers
preclinical-data
Programme phase
Non-hallucinogenic 5-HT2A/2C agonists — OUD/TRD discovery
NIH/NIDA-funded discovery and lead-optimization programme for non-hallucinogenic 5-HT2A/2C receptor agonists, initially focused on OUD with TRD also listed in company pipeline language.
View profile contextindustry-media · Psychedelic Alpha · Jun 26, 2026 · Verified
5 sources
0 trials · 0 papers
Preclinical started · likely Q4 2026
Programme phase
MIA Neuroplastogen Discovery Platform (Yeast Biomanufacturing)
Discovery-stage platform remains active; Biomia announced an IRLAB collaboration in January 2026 to evaluate drug candidates using IRLAB's Integrative Screening Process.
View profile contextcompany-website · Biomia · Jun 26, 2026 · Verified
Milestone: Company milestone · actual Jan 1, 2022
8 sources
0 trials · 0 papers
candidate-selection
Programme phase
Biosynthetic Psilocybin / Tryptamine Platform
Precision fermentation platform for psilocybin, DMT, and tryptamine analogues. Cleveland Clinic MOU (2020) for clinical trial supply. No clinical trials initiated. No public updates since mid-2020.
View profile contextcompany-website · CB Therapeutics · Jun 26, 2026 · Verified
8 sources
0 trials · 0 papers
preclinical-data
Programme phase
DMT / Tryptamine Analogues — Precision Fermentation Discovery
Discovery/supply-platform programme. CB Therapeutics has demonstrated DMT and tryptamine analogue biosynthesis in yeast and now presents TryptageniX as a rare-alkaloid precision-fermentation programme; no sponsor-led clinical trial has been disclosed.
View profile contextcompany-website · CB Therapeutics · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
preclinical-data
Programme phase
Elk1 Neuroplastogen Discovery Programme (Depression)
Discovery/lead-optimization stage; Elkedonia launched with an 11.25M seed round in June 2025 and recent coverage continues to describe first-in-class Elk1 inhibitors for treatment-resistant depression.
View profile contextindustry-media · Pharmaceutical Technology · Jun 19, 2026 · Verified
Milestone: Funding milestone · actual Jun 11, 2025
8 sources
0 trials · 0 papers
candidate-selection
Programme phase
ET-01 — Preclinical Discovery
iPSC-based high-throughput neuroplasticity screening underway. ET-01 identified as lead from botanical compound library. Preclinical characterisation in progress — no IND filed, no ClinicalTrials.gov entries. Company is entirely in discovery/preclinical stage. $3.58M seed capital secured Sep 2024, SEC Form D filed Oct 2024 for up to $10M raise. Team building with world-class SAB: Robin Carhart-Harris, Adam Gazzaley, Sarah O'Connor.
View profile contextindustry-media · Psychedelic Alpha · Jun 27, 2026 · plausible
5 sources
0 trials · 0 papers
preclinical-data
Serotonin Releaser Platform (MDMA-Inspired & Fenfluramine-Class)
Compound not specified
Programme phase
Serotonin Releaser Platform - PTSD/SUD Discovery
Discovery-stage 5-HT releaser platform covering an MDMA-inspired PTSD asset and a next-generation fenfluramine-class programme. Equulus lists candidate selection as the next milestone; October 2025 secondary coverage also describes the 5-HT releaser/MDMA analog and related non-psychedelic pipeline. No IND has been disclosed for the serotonin-releaser assets.
View profile contextcompany-website · RTI International · Jun 27, 2026 · Verified
7 sources
0 trials · 0 papers
Discovery completed
Programme phase
PSY-01 — Lead Optimization (MDD / Parkinson's)
Lead optimization. NIMH SBIR Phase I funded ($458,385) — "Development of brain-penetrant COMT inhibitors for the treatment of depressive disorders." In-vivo biomarker data (PRT mouse model) targeted Mar 2025. Novel non-nitrocatechol scaffold from X-Chem DEL screen avoids liver toxicity and poor CNS penetration of existing COMT inhibitors.
View profile contextcompany-website · Psy Therapeutics · Jun 26, 2026 · Verified
2 sources
0 trials · 0 papers
preclinical-data
Programme phase
PSY-02 — Lead Optimization (Alzheimer's / Tauopathies)
Current Psy site lists PSY-02 as a tau oligomerization inhibitor rapidly advancing through lead optimization. March 2025 company highlights said cell-based assays confirmed tau anti-aggregation and Michael J. Fox Foundation financed in-vivo proof-of-principle readouts were expected in 2H25; Synapse still lists PSY-02 as preclinical in its 2026 snapshot. No public PoC readout was found in this sweep.
View profile contextcompany-website · Psy Therapeutics · Jun 27, 2026 · Verified
Milestone: Funding milestone · actual Jan 1, 2024
5 sources
0 trials · 0 papers
preclinical-data
Programme phase
PSY-06 — Lead Optimization (MDD)
Psy Therapeutics current pipeline does not list a separate PSY-06 asset. Synapse tracks PSY-06 as pending/preclinical for depressive disorder in its 2026 organization snapshot and direct drug profile. Keep as secondary-source-only pending company confirmation.
View profile contextcompany-website · Psy Therapeutics · Jun 27, 2026 · Verified
3 sources
0 trials · 0 papers
programme-status-update
Programme phase
CX157 + 5-MeO-DMT - Oral Combination Discovery
Discovery-stage oral combination concept pairing CX157, a selective reversible MAO-A inhibitor, with 5-MeO-DMT or other 5-HT2A agonists. Public evidence is limited to Remedi platform language and a published patent family; no IND or trial has been found.
View profile contextcompany-website · Remedi Therapeutics · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Preclinical started
Programme phase
Undisclosed Neuroplastogen Programme 2 - Discovery
Undisclosed second programme in Transneural broader small-molecule neuroplastogen pipeline. Public materials confirm two additional programmes beyond TN-001, but mechanism, candidate name, and indication remain undisclosed.
View profile contextcompany-website · Transneural Therapeutics · Jun 26, 2026 · Verified
4 sources
0 trials · 0 papers
Discovery completed
Expected trial, readout, regulatory, publication, and stale-window rows across late-stage programmes.
Biomia is a Copenhagen-based synthetic biology company developing novel plant-inspired drug candidates for unmet medical needs in pain, addiction, and depression. Using a proprietary AI-assisted drug discovery engine and fermentation-based biomanufacturing platform, the company engineers Monoterpene Indole Alkaloid (MIA) derivatives — a large family of plant-derived bioactive compounds including ibogaine analogs — with optimised halogenation to improve ADME properties and therapeutic profiles.
CB Therapeutics is a Carlsbad, California-based synthetic biology company developing biosynthetic psychedelic compounds and their novel analogues using a proprietary yeast fermentation platform. Founded in 2015, the company has raised $11.62M from investors including Y Combinator, Pioneer Fund, and re.Mind Capital. CB Therapeutics has achieved biosynthesis of psilocybin, psilocin, DMT, and MDMA analogs, holds seven granted patents with twelve pending, and has partnered with atai Life Sciences and Cleveland Clinic for clinical supply. Its PsyVault™ platform houses the largest collection of biosynthetic psychedelics and analogues.
Elkedonia is a French neuroplastogen biotech developing novel small molecules targeting the Elk-1 transcription factor, a key regulator of neuroplasticity within neuronal cells. Backed by €11 million in funding, the company is advancing clinical research into next-generation antidepressants that promote neuroplasticity without the adverse effects of traditional treatments, with CEO Delphine Charvin leading the programme.
Entheos Labs is a Boston-based psychedelic medicines company founded in 2022 by Dr. Jerry Rosenbaum and Tristan Edwards, dedicated to discovering, developing, and deploying novel psychedelic medicines for unmet medical needs. The company is creating a pipeline of new chemical entities derived from overlooked natural psychedelic materials, with its lead candidate ET-01 targeting mood, anxiety, trauma, and substance use disorders.
2A Biosciences is a drug discovery company developing Serotonergic Anti-Inflammatories (SAIs) — non-hallucinogenic 5-HT2A receptor agonists that harness the peripheral anti-inflammatory properties of psychedelics without behavioural effects. Co-founded by pharmacologists Charles D. Nichols and David E. Nichols, the company's near-term programs target dermatological inflammatory conditions, with a broader platform addressing autoimmune and cardiovascular disease. The company has completed an oversubscribed seed round backed by biotech and psychedelic VCs.
The Alexander Shulgin Research Institute (ASRI) was founded in 2021 by Dr. Nicholas Cozzi, Dr. Paul Daley, and the late Ann Shulgin, continuing the legacy of chemist Alexander Shulgin. The institute maintains the Shulgin Vault — a repository of over 500 compounds synthesized by Shulgin and ASRI scientists. Lead candidate ASR-3001 (5-MeO-iPALT) is an orally active, fast-acting tryptamine with a mild internal psychedelic profile and no visual hallucinations, near IND-ready for psychiatric disorders. ASR-2001 is a non-hallucinogenic compound producing mental clarity.
Alvarius Pharmaceuticals is an Irish bio-pharmaceutical company developing 5-MeO-DMT-based therapies for addiction and substance use disorders. Founded in 2021 and based in Dublin, the company conducts preclinical studies in collaboration with University College Dublin, combining acute 5-MeO-DMT administration with guided psychotherapy. Alvarius raised €5.5M in 2023 and has filed one patent.
BetterLife Pharma (CSE: BETR / OTC: BETRF) is a Canadian biotech developing BETR-001, a first-in-class non-hallucinogenic LSD derivative (2-bromo-LSD / BOL-148) for MDD, anxiety, and neuropathic pain. BETR-001 was acquired from Transcend Biodynamics LLC and activates the 5-HT2A receptor at 60% efficacy — sufficient for neuroplastogenic antidepressant effects but below the threshold for hallucinogenic effects. A composition of matter patent was granted January 2025, IND filing projected H1 2026.
CaaMTech is a US psychedelic drug discovery company based in Issaquah, Washington, focused on novel tryptamine chemistry. Founded around 2018, the company raised $22M in a 2021 Series A and holds a CRADA with NIH/NIDA and a research collaboration with UMass Dartmouth. Its two flagship compound series are Prophoria™ (4-AcO-DMT analogues) and Amphoria™ (4-HO-MiPT analogues), which the company is developing as improved psychedelic therapeutics with potentially more targeted and safer profiles than existing compounds.
Enveric Biosciences (NASDAQ: ENVB) is a clinical-stage biotech developing novel non-hallucinogenic neuroplastogenic DMT analogs for depression, anxiety, and addiction via its Psybrary™ discovery platform. Lead candidate EB-003 is a first-in-class compound designed to selectively engage both 5-HT2A and 5-HT1B receptors, delivering fast-acting antidepressant and anxiolytic effects without hallucinations. EB-003 completed pre-IND dose range studies (Aug 2025) and demonstrated positive preclinical PTSD data (July 2025), with IND filing targeted Q3 2025 and clinical initiation by end of 2025.
Equulus Therapeutics (Raleigh, NC) was founded in 2023 to develop non-hallucinogenic, non-cardiotoxic ibogaine analogs for substance use disorders. Lead candidate EQL-101 retains ibogaine’s anti-addictive efficacy while eliminating its hallucinogenic effects and cardiotoxicity (hERG inhibition). The company is advancing EQL-101 through IND-enabling studies targeting first-in-human dosing by Q4 2026. Co-founded by RTI medicinal chemist Bruce Blough and pharmacologist Kevin Murnane (LSU), who received a $2.4M NIH grant for methamphetamine use disorder research.
Journey Colab is a US psychedelic pharmaceutical company developing synthetic mescaline hydrochloride for alcohol use disorder (AUD). Founded in 2020, the company has raised $30.7M from investors including Sam Altman, Apollo Projects, and Drew Houston. Journey Colab has dedicated 10% of its founding equity to a Reciprocity Trust supporting Indigenous communities from which mescaline knowledge originates. The company is partnering with All Points North (APN) for an FDA-authorised Phase 2 clinical trial.
Kuleon Bioscience is a Seattle-based drug discovery company leveraging AI-based technology to identify novel serotonergic drugs for neuropsychiatric diseases. The company specialises in biased serotonin receptor ligands — including the world's first known trifunctional 5-HT2C agonist / 5-HT2A antagonist / 5-HT2B antagonist — designed to deliver therapeutic efficacy without hallucinogenic or cardiotoxic side effects. Its lead programme KB-128 targets alcohol use disorder and is supported by a $2 million NIAAA grant.
Marvel Biosciences is a Calgary-based clinical-stage biotechnology company pursuing a 'drug redevelopment' strategy to create synthetic derivatives of approved drugs with improved therapeutic profiles. Its lead candidate MB-204, a fluorinated derivative of the adenosine A2a receptor antagonist Istradefylline, is advancing through IND-enabling pre-clinical studies targeting autism spectrum disorder, Rett syndrome, and depression, with Phase 1 trials expected to begin in Australia.
Palomar Labs (formerly Negev Labs) is a brain-health venture builder headquartered in New York, with operations in Vienna. The firm identifies overlooked medicines with documented histories of human use, develops new intellectual property around them, and builds a category-owning company around each asset. Its team, thesis, and portfolio continue from Negev Labs, with a focus on neuropsychiatric diseases and the aging brain.
PharmAla Biotech (CSE: MDMA) is a Canadian biotech specialising in MDXX-class molecule R&D and GMP MDMA manufacturing. Founded in January 2021 by CEO Nick Kadysh, the company operates two business lines: (1) LaNeo — clinical-grade GMP MDMA supplied to research institutions worldwide under a supply-for-data model, now with a US distribution hub and agreements spanning Mt. Sinai, Yale, UAB, University of Washington, and institutions in Norway and Netherlands; and (2) proprietary drug development led by ALA-002, a patented non-racemic MDMA (70–80% R-MDMA / 20–30% S-MDMA) targeting social anxiety in autism, plus APA-001, a novel non-scheduled MDXX molecule discovered via University of Windsor AI collaboration. ALA-002 holds US Patent No. 12,053,452 (composition of matter, issued 2024), MHRA written guidance that no further preclinical data is needed, and FDA NCE classification. Phase 2a clinical trial drug substance manufacture was contracted with a UK CDMO in December 2025 in preparation for an Australian Phase 2a with University of Sydney (Dr. Adam Guastella). Revenue grew 95% in FY2024 to C$1.04M from MDMA product sales. Note: master list originally classified as private, but is publicly listed on CSE.
Psilera is a Florida-based drug discovery company developing non-hallucinogenic psilocybin derivatives and outpatient-compatible psychedelic medicines. Founded in 2019, the female co-founded company has a proprietary compound library of over 1 million novel compounds. Lead candidate PSIL-006 is a non-hallucinogenic psilocybin derivative targeting behavioral variant frontotemporal dementia (bvFTD), with positive preclinical in vivo efficacy data in humanized tau mouse models. Earlier compounds PSIL-001/002 (DMT derivatives) showed improvements in learning and memory.
Psy Therapeutics is a Cambridge, MA-based drug discovery company developing novel small-molecule NCEs for neuropsychiatric and neurological disorders. Founded around 2019 by MGH psychiatrists Jerry Rosenbaum, Roy Perlis, and Maurizio Fava with Brant Binder, the company applies DNA-encoded library screening (via X-Chem) and validated CNS targets. Pipeline includes PSY-05 (anxiety), PSY-06 (MDD), PSY-02 (dementia/tau aggregation), and programs in Parkinson's and chronic pain. Non-hallucinogenic, psychedelic-inspired CNS approach.
Red Light Holland (Cboe CA: TRIP) is a Canadian company producing and distributing legal psilocybin magic truffles to adult consumers in the Netherlands under the iMicrodose and Trip brands, and developing pharmaceutical-grade psilocybin through its Irvine Pharma subsidiary. On 30 April 2026 it completed the acquisition of Filament Health, adding Filament's patented PEX010 botanical psilocybin drug candidate — used across more than 80 clinical and academic studies worldwide — and its portfolio of 76 issued patents to the group.
Remedi Therapeutics is a private biotech company developing a novel oral DMT formulation combined with a best-in-class, ultra-selective monoamine oxidase A inhibitor (RIMA) to create a predictable, convenient ayahuasca-like therapeutic. Unlike traditional ayahuasca, which uses plant-sourced harmine with off-target effects, Remedi's proprietary RIMA avoids gastrointestinal distress, tremors, and hypertensive risk, enabling pharmaceutical-grade oral DMT delivery for neuropsychiatric conditions.
Shortwave Life Sciences is a UK-listed biopharmaceutical company developing a proprietary psilocybin and beta-carboline buccal film formulation for the treatment of anorexia nervosa. The mucoadhesive film delivery system enables improved bioavailability and rapid onset by bypassing first-pass metabolism, and the company has secured an investigator-initiated Phase 2 clinical trial agreement with Sheba Medical Center in Israel — targeting a condition with no FDA-approved pharmacological treatment.
US-listed clinical-stage biotech developing psychedelic and ketamine-based therapies for PTSD and chronic pain. SPC-15 is an intranasal 5-HT4 serotonin receptor agonist for PTSD in IND-enabling GLP studies. SP-26 is a proprietary ketamine implant for fibromyalgia being co-developed with the University of Maryland.
Soneira is a private psychedelic biotech company developing synthetic ibogaine therapies for neuropsychiatric conditions, with a primary focus on traumatic brain injury (TBI). The company has raised $15 million from Sergey Brin's Catalyst4 investment vehicle and is working to advance the first FDA-approvable synthetic ibogaine candidate to clinical trials.
Tactogen is a Palo Alto-based public benefit corporation developing novel MDMA-like entactogens and psychedelic-adjacent molecules for psychiatric disorders. Founded in 2020 by neuroscientist Matthew Baggott and Luke Pustejovsky, Tactogen has built the largest known library of entactogenic compounds. Lead candidate TACT908 is a non-hallucinogenic 5-HT1B/2A agonist for cluster headache, while TACT833 targets alcohol use disorder and eating disorders. Following the 2024 FDA rejection of Lykos's MDMA, Tactogen has pivoted toward its novel NCE pipeline.
Transneural Therapeutics is a Washington-based preclinical biotech spun out from CaaMTech in April 2025, developing AI-engineered non-hallucinogenic neuroplastogens for neuropsychiatric disorders. Lead candidate TN-001 is a dual 5-HT2A partial agonist/5-HT2B antagonist designed to deliver rapid antidepressant efficacy without hallucinations, potentially enabling outpatient dosing. TN-001 is in IND-enabling studies for MDD and PTSD, with preclinical data presented at ACNP 2026. CEO Charmaine Lykins brings experience from Karuna, ACADIA, and MapLight.
Xylo Bio (formerly Psylo) is an Australian-US biotech developing next-generation neuroplasticity-promoting therapeutics for mental health. Founded in 2021 by Josh Ismin and Sam Banister in Sydney, the company has labs at the University of Colorado Boulder and the University of New South Wales. Its lead candidate PSYLO-100X is a non-hallucinogenic compound designed for home administration without clinical supervision, advancing through IND-enabling studies toward first-in-human trials. Xylo has raised $14.2M including an $8M seed round in June 2024 from Tenmile, Focalpoint Partners, and Palo Santo.
Algernon Pharmaceuticals (also known as Algernon Health / Algernon NeuroScience) is the first company in the world to test DMT as an emergent treatment for ischemic stroke and traumatic brain injury. Their lead candidate AP-188 uses sub-hallucinogenic IV DMT to promote neuroplasticity and neuroprotection. Phase 1 completed at the Centre for Human Drug Research in Leiden; Phase 2a stroke trial planned.
Arcadia Medicine is a San Francisco-based biotech developing safe entactogens for mental health disorders. Their lead candidate AM-1002 is a patented non-racemic MDMA formulation that received FDA IND clearance in October 2025 for Phase 1 trials in generalized anxiety disorder. Backed by investors including Sam Altman and Coinbase co-founder Fred Ehrsam.
DemeRx is a clinical-stage biotech developing noribogaine (DMX-1001), a non-psychedelic active metabolite of ibogaine, as a treatment for alcohol use disorder. DMX-1001 promotes neuroplasticity to repair neural circuits damaged by chronic alcohol use. Phase 1b completed with favorable safety; Phase 2 AUD trial planned for 2026, supported by a $1.7M NIH SBIR grant.
Canadian psychedelic biotech developing conjugated psilocin formulations for treatment-resistant conditions. Spun out its proprietary Conjugated Psilocin™ technology to Cynaptec Pharmaceuticals in April 2025 via an $8.46 million financing round. Lead programme L-130 targets cluster headache disorder.
Lophora ApS is a Danish biotech developing next-generation selective 5-HT2A receptor agonists for psychiatric disorders. Their lead compound LPH-5, a novel cyclized phenethylamine, is in Phase 1 trials at Biotrial in Rennes, France. LPH-5 shows exceptional 5-HT2A selectivity and can produce antidepressant effects at sub-psychedelic doses. Secondary candidate LPH-48 is being explored for alcohol use disorder.
Clinical-stage AI neuroengineering platform company focused on designing psychoactive effect profiles and developing next-generation neuropsychiatric programs with psychedelic relevance.
MycoMedica Life Sciences PBC is a public benefit corporation developing low-dose psilocybin medicines for psychiatric and neurological disorders. Their lead candidate MLS101 is in Phase 1 clinical development, with PMDD as the lead indication and OUD and OCD as additional targets. Based in Shelton, Washington.
Neurala Biosciences is a Melbourne-based clinical-stage biotech developing second-generation DMT–harmala alkaloid neuromedicines for mental health and addiction. Emerging from over a decade of research at the University of Melbourne, their Phase 1 proof-of-concept study was published in Scientific Reports (2025). Lead candidate NBX-100 targets substance use disorder; NBX-200 targets depressive illness.
Scottsdale Research Institute (SRI) is an Arizona-based research organization conducting the world's first controlled clinical trial of whole psilocybin mushrooms. Their FDA-approved Phase 1 study tests naturally-grown whole mushrooms (30mg psilocybin dose) for PTSD in first responders and military veterans, funded by $5M from the Arizona Legislature. The study explores the entourage effect hypothesis compared to isolated synthetic psilocybin. Led by Dr. Sue Sisley.
Terran Biosciences is a New York-based drug discovery platform company developing transformative therapeutics for neurological and psychiatric diseases. Founded by CEO Samuel Clark, the company holds over 200 patent applications covering novel formulations of psychedelic compounds including LSD, DMT, psilocybin, and MDMA, and operates clinical programs in schizophrenia and depression. Its AI-enabled neuromelanin MRI software platform NM-101 has received FDA clearance.
AbbVie (NYSE: ABBV) is a global biopharmaceutical company and one of the first large pharma entrants in next-generation psychedelic medicine. In May 2024, AbbVie partnered with Gilgamesh Pharmaceuticals ($65M upfront, up to $1.95B in milestones) to develop novel CNS therapies including neuroplastogens. In August 2025, AbbVie acquired bretisilocin (GM-2505) — a short-acting IV serotonergic psychedelic (DMT analog) from Gilgamesh — for up to $1.2B, marking one of the largest psychedelic drug deals in history. Bretisilocin's Phase 2a data showed a -21.6 point MADRS reduction at Day 14 (p=0.003). AbbVie continues to collaborate with Gilgamesh Pharma Inc. (Gilgamesh's spin-off) on earlier-stage programmes.
Amandala Neuro is a London-based clinical-stage biopharmaceutical company pioneering short-acting psychedelic treatments for unmet psychiatric needs. The company is developing patient-centered therapies designed to integrate within established psychiatric care settings. Specific drug candidates and clinical programs have not yet been publicly disclosed.
Apex Labs Ltd. is a private Canadian clinical-stage company developing psilocybin treatments for depression, anxiety, and PTSD, with a focus on the Veteran community. The company is advancing two parallel Phase 2b programmes: APEX-52 (take-home oral microdose psilocybin, the first of its kind in a Phase 2b trial) and APEX-90 (in-clinic macrodose psilocybin with assisted psychotherapy). Trials are running across Canada, the US (Yale School of Medicine PK study), and Israel (Tel Aviv University Sagol Brain Institute + Be'er Yaakov Mental Hospital, approved June 2025).
AtaiBeckley Inc. is a clinical-stage biotechnology company formed in 2025 through the strategic combination of atai Life Sciences and Beckley Psytech. It operates as a public company focused on developing rapid-acting, durable, and convenient mental health treatments, with a strong psychedelic-therapeutics emphasis. Its principal executive office is in New York, New York, United States. AtaiBeckley matters in the psychedelic ecosystem because it combines clinical development capabilities with a public-market platform that can support late-stage psychedelic drug programs. Public disclosures describe pipeline work that includes BPL-003 and note that the company’s psychedelic-based therapies are being advanced through the Beckley Psytech strategic investment and later combination. AtaiBeckley's corporate lineage runs through several psychedelic companies. Its lead asset BPL-003 (intranasal mebufotenin) originated at Beckley Psytech, the UK developer that in October 2022 acquired Eleusis Therapeutics, bringing in Eleusis's team (led by founder Shlomi Raz) and the intravenous-psilocin candidate ELE-101. atai Life Sciences, founded in 2018, first took a strategic stake in Beckley Psytech and then combined with it in an all-share transaction that closed on 5 November 2025 to create AtaiBeckley. Shortly before that close, Beckley carved out the Eleusis ELE-101 asset and distributed it back to its shareholders, so that programme did not pass to AtaiBeckley. On 16 July 2026, Eli Lilly agreed to acquire AtaiBeckley for up to approximately US$3.8 billion (US$6.75 per share in upfront cash, about US$2.8 billion, plus up to US$2.50 per share in milestone-based contingent value rights), the largest psychedelic-focused acquisition to date. The deal is expected to close in the third quarter of 2026 subject to shareholder approval, and gives Lilly AtaiBeckley's late-stage pipeline led by BPL-003, an intranasal mebufotenin (5-MeO-DMT) therapy in Phase 3 for treatment-resistant depression, alongside VLS-01 (a DMT oral film) and EMP-01 (an oral (R)-MDMA candidate).
Biomind Labs (NEO: BMND) is a Canadian clinical-stage biopharmaceutical company developing inhaled DMT, sublingual 5-MeO-DMT, and mescaline-class compounds across TRD, Alzheimer's-related depression, obesity/neuroinflammation, and Parkinson's disease. Founded in 2019 and publicly listed via RTO in July 2021, the company's clinical work is primarily conducted in Brazil (UFRN, PI Prof. Dráulio de Araujo) and Argentina (Dr. Martin Bruno). Their BMND08 (sublingual 5-MeO-DMT for Alzheimer's depression) achieved a 100% remission rate in a Phase 2 RCT at subpsychedelic doses (February 2024) and is now advancing to FDA-directed Phase 3 via a proprietary nano-formulation platform with FDA Breakthrough Therapy Designation planned. BMND01 (inhaled DMT) is in Phase 2 for TRD with the unique advantage of a ~10-minute experience duration vs hours for psilocybin or LSD. Note: master list originally classified as private, but is publicly listed on NEO/CBOE.
Bright Minds Biosciences (NASDAQ: DRUG) is a Vancouver-based biotech developing highly selective serotonergic agonists for neurological and psychiatric disorders. Lead asset BMB-101, a 5-HT2C agonist, is in Phase 2 for drug-resistant epilepsy (BREAKTHROUGH study, positive Phase 2 results January 2026). BMB-201 is a 5-HT2A/2C agonist showing preclinical efficacy in pain and migraine models (outperformed sumatriptan, Sept 2025). BMB-202 is a selective 5-HT2A agonist with antidepressant profile in development for MDD.
Ceruvia Lifesciences is a US-based clinical-stage biopharmaceutical company founded in 2017 by philanthropist Carey Turnbull, focused on developing neurotransformational medicines for neurological and psychiatric disorders. The company was the world's first producer of cGMP-certified LSD and its non-hallucinogenic analogue BOL-148. Ceruvia is advancing SYNP-101 (synthetic psilocybin) through Phase 2 trials for OCD, alcohol use disorder, and migraine/headache disorders, and NYPRG-101 (BOL-148) for cluster headache. Collaborators include Yale University, the Heffter Research Institute, Usona Institute, NYU, and Clusterbusters.
Clairvoyant Therapeutics is a Canadian clinical-stage biotech developing synthetic psilocybin for alcohol use disorder (AUD). The company ran a fully randomized, double-blinded Phase IIb multi-country trial in the EU and Canada enrolling 154 participants, with topline data anticipated in early 2025. Founded in 2021 in Vancouver, a proposed acquisition by Psyence Biomed (Nasdaq: PBM) for $500K in September 2024 fell through following due diligence.
Clexio Biosciences is a private Israeli clinical-stage CNS company founded in 2018 by Teva Pharmaceuticals R&D veterans. Their lead programme CLE-100 is a once-daily oral tablet formulation of esketamine for MDD — distinguished from the FDA-approved Spravato (intranasal, in-clinic) by enabling outpatient, at-home use. Phase 2 CLEO study results showed a promising safety profile and encouraging efficacy specifically in post-COVID MDD subgroups; the Phase 2 SOLEO study (NCT06340958, higher dose, stricter treatment-resistance criteria) enrolled first patients April 2024 and reached 50% enrollment by December 2024. CLE-100 holds multiple US method-of-use patents (2024). In December 2025, Clexio spun out its muscarinic agonist programme (CLE-905) into a new entity, Syremis Therapeutics, which raised $165M Series A co-led by Dexcel Pharma and Third Rock Ventures. Co-founders Kogan, Levy, and Kagan simultaneously lead Syremis; Clexio continues independently with CLE-100 and preclinical CLE-043.
Delix Therapeutics is harnessing the power of neuroplastogens, a novel class of compounds designed to bring about a new paradigm in brain health therapeutics with treatments intended to be safe, fast-acting, and long-lasting. Through its discovery platform, Delix has identified non-hallucinogenic versions of psychedelic compounds with favorable safety and therapeutic profiles. The company was co-founded in 2019 by David E. Olson and Nick Haft, building upon Olson's discovery at the University of California, Davis, of several novel psychoplastogens that have significant therapeutic potential in preclinical models, without hallucinogenic side effects. Delix's treatments are designed to address the root cause of neuropsychiatric conditions by repairing the underlying synaptic damage through targeted neuroplasticity. To date, the company has synthesized over 2000 novel psychoplastogens, many of which are analogs of known psychedelics such as ibogaine and 5-MeO-DMT. Their lead compound, zalsupindole (DLX-001), produces the same rapid and sustained structural and functional plasticity as ketamine, psilocybin, and DMT, without inducing hallucinations or dissociation. Recent Phase I data have demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. The company's compounds are tailored for swift neuronal repair and can be taken at-home, providing significant advantages to patients, their loved ones, and healthcare providers. Delix focuses on developing non-hallucinogenic psychoplastogens as scalable alternatives to first-generation hallucinogenic psychoplastogens like ketamine and psilocybin.
Diamond Therapeutics is a private Canadian clinical-stage company pioneering sub-perceptual (non-hallucinogenic) psilocybin therapy. Their approach focuses on low-dose psilocybin that does not produce psychedelic experiences, enabling at-home outpatient administration — a differentiated strategy from the clinic-based, high-dose psychedelic-assisted therapy model. Founded in 2018 by CEO Judith Blumstock, Diamond completed a Phase 1 single ascending dose study in healthy volunteers (n=56, 7 cohorts, December 2022) establishing a safe non-hallucinogenic dose range. Their Phase 2a GAD programme received Health Canada approval in January 2023 — the first Health Canada NOL for a psychedelic trial in GAD — and enrolled first patients at Kingston Health Sciences Centre in 2025 in the first-ever at-home microdose psilocybin study. A parallel FDA-authorized Phase 2 demoralization trial is also underway at UAB. Diamond is funded by private investors and non-dilutive public grants, including a $1.1M+ CQDM/Brain Canada drug discovery consortium launched in May 2025.
Australian clinical-stage biotech pioneering psychedelic-assisted therapies. In 2025, Emyria became the first company in the world to commercially deliver MDMA-assisted psychotherapy for PTSD, with insurance funding secured from Medibank. Also operates a clinical trial division and an MDMA analogue discovery program in collaboration with the University of Western Australia.
Entropy Neurodynamics Limited (formerly Tryptamine Therapeutics Limited, renamed November 2025; ASX: ENP, OTC: TYPTF) is an Australian clinical-stage company developing psilocin-based therapies for conditions with major unmet need including fibromyalgia, binge eating disorder, and IBS. Its two-pronged strategy uses TRP-8802 (oral psilocybin) to establish clinical proof-of-concept, then advances TRP-8803 (proprietary IV psilocin formulation) for precision dosing. Phase 2a fibromyalgia and BED trials showed strong results; the world's first IV psilocin neuropsychiatric trial (TRP-8803 in BED) dosed its first patient on December 1, 2025 at Swinburne University.
Filament Health is a Canadian natural-psychedelics drug-development company and a leading supplier of pharmaceutical-grade botanical psilocybin. Its patented lead candidate, PEX010, is a standardised natural psilocybin drug candidate used across more than 80 academic and clinical studies worldwide, including Germany's compassionate-use programme and numerous depression, PTSD and cancer-distress trials. On 30 April 2026, Filament was acquired by and became a wholly-owned subsidiary of Red Light Holland (Cboe CA: TRIP), which now advances the PEX010 supply business and a patent portfolio of 76 issued patents across 15 families. In July 2026 Filament agreed to supply PEX010 for an ARQ National Psychotrauma Centre veterans-PTSD study in the Netherlands.
Freedom Biosciences is a Yale University spin-out developing next-generation combination therapies for treatment-resistant depression. Co-founded by Yale psychiatry chair Dr. John Krystal (CSO) and Dina Burkitbayeva (CEO, PsyMed Ventures), the company raised $10.5M seed financing in August 2022. Its lead asset FREE001 combines ketamine with temsirolimus (an mTOR inhibitor and prodrug of sirolimus) to extend the antidepressant duration of ketamine from the standard 2–7 days to approximately 14 days. FDA cleared the IND for the Phase 2a study in April 2024, and the trial (FREE001-TRD-201, n≥100) is underway.
Gilgamesh Pharma Inc. is the post-spinoff successor of Gilgamesh Pharmaceuticals, created in October 2025 when AbbVie acquired Gilgamesh's lead asset bretisilocin (GM-2505) for up to $1.2B. Launched with over $100M in funding and retaining the original team, Gilgamesh Pharma is advancing a pipeline of rapid-acting, durable psychiatric therapeutics including blixeprodil (GM-1020), a first-in-class oral NMDA receptor antagonist. Positive Phase 2a data for blixeprodil were announced January 6, 2026, and late-stage development is planned for 2026. The company also retains an ongoing AbbVie collaboration on non-hallucinogenic neuroplastogens.
Incannex Healthcare is an Australian clinical-stage pharmaceutical company (ASX: IHL, Nasdaq: IXHL) developing psilocybin-assisted therapy and novel fixed-dose combinations. Their lead psychedelic programme PSX-001 is synthetic psilocybin combined with a proprietary psychotherapy protocol for Generalised Anxiety Disorder (GAD) — the world's first RCT of psilocybin-assisted therapy for a primary anxiety disorder. The Phase 2 PsiGAD1 trial (n=73) at Monash University delivered strongly positive results in August 2025: HAM-A reduction of 12.8 vs 3.6 points for placebo (p<0.0001), with 44% clinical response vs 11% for placebo. FDA cleared a Phase 2b IND (PsiGAD2) in August 2024 for US and UK sites; MHRA Clinical Trial Authorisation also granted. Incannex entered 2026 well-funded (~$70M cash) and with PsiGAD2 site start-up underway. The company also has non-psychedelic programmes: IHL-42X (dronabinol + acetazolamide for OSA, Phase 2/3, FDA Fast Track) and IHL-675A (CBD + hydroxychloroquine for rheumatoid arthritis, Phase 2).
Ketabon GmbH is a Munich-based joint venture between HMNC Brain Health and Develco Pharma developing KET01, an oral prolonged-release (PR) racemic ketamine tablet for TRD. Founded in 2022, Ketabon's strategy centres on enabling at-home, unsupervised ketamine therapy by dramatically reducing dissociation and cardiovascular side effects through slow drug release. Two Phase 2 studies are complete: KET01-01 (UZH investigator-initiated PoC, ~zero dissociation, trend toward MADRS improvement at 240mg) and KET01-02 (n=122, 29 sites across Germany/Poland/Czech Republic, 240mg arm showed statistically significant rapid-onset MADRS improvement at Day 4 and 7, sustained through Day 21 and 4-week follow-up; primary Day 21 endpoint missed due to high placebo response). A head-to-head study vs. Spravato (esketamine nasal spray) confirmed significantly lower dissociation for KET01. Post-hoc analysis presented at ECNP Amsterdam (October 2025) demonstrated that KET01's antidepressant effect is dissociation-independent, strengthening the regulatory case for home use. Phase 3 initiation was targeted for 2025; IP exclusivity through 2039.
MSICS Pharma is an Israeli biotechnology company that operates a GMP production facility for naturally-sourced psilocybin. Their lead candidate MSX-06, a naturally-sourced psilocybin formulation, is in Phase 2 clinical development targeting treatment-resistant depression and obsessive-compulsive disorder.
MindBio Therapeutics is a clinical-stage biotechnology company developing MB22001, a proprietary titratable form of LSD designed for take-home microdosing. The company's Phase 2B trials in major depressive disorder and advanced-stage cancer distress have reported strong antidepressant effects, with Phase 2a data showing a 72% reduction in depressive symptoms and 58% remission at six months. MindBio is listed on the Canadian Securities Exchange and the Frankfurt Stock Exchange.
Canadian drug discovery company focused on next-generation psilocybin and DMT analogues, acquired by Otsuka Pharmaceutical in October 2023 for approximately C$80 million. Lead compound MSP-1014, a novel psilocin prodrug, received MHRA approval for a Phase 2 clinical trial in the UK for major depressive disorder.
Canadian biotech using AI-assisted drug discovery at the University of Alberta to develop novel psilocybin and MDMA analogues for mental health and addiction treatment. Pipeline compounds MYCO-003 through MYCO-007 represent a library of psychedelic-inspired molecules at preclinical stage.
Neurocentrx Pharma Limited is a private Scottish clinical-stage company developing NRCx-201 (Keticap) — an immediate-release, abuse-deterrent oral ketamine capsule paired with proprietary digital prescription safety software for regulated clinic-to-home care. Founded in 2013 by CEO Carmel Reilly at the University of Edinburgh, the company raised ~$6.15M total including a September 2025 seed extension (~$5M) led by the Wellcome Trust to fund a Phase 2 proof-of-concept trial in treatment-resistant bipolar depression (planned Q1 2026). Phase 1 (King's College London, EudraCT 2019-001019-22, n=18, 40–240mg) completed early 2023 with positive results: well-tolerated at all doses, no SAEs, PK comparable to IV/intranasal esketamine, no cognitive impairment. MHRA has indicated NRCx-201 is suitable for direct Phase 3 submission for TRD (company plans Phase 2 first). Key investors: Wellcome Trust, Neo Kuma Ventures, O2h Ventures, Equity Gap.
Psyence Biomedical (Nasdaq: PBM) is a clinical-stage company developing nature-derived (non-synthetic) psilocybin and ibogaine therapeutics. Spun out of Psyence Group via SPAC in early 2024, PBM is conducting a Phase IIb trial of its NPX5 botanical psilocybin product for Adjustment Disorder in cancer patients receiving palliative care — with three active sites across Australia (Perth and Melbourne). The company positions itself as the first Nasdaq-listed company focused on nature-derived psychedelic therapeutics and claims a first-mover position in psilocybin for Adjustment Disorder. It also holds worldwide exclusive licensing rights for nature-derived psilocybin in AUD and has secured GMP-compliant ibogaine HCl supply for a planned SUD programme. Note: the original CSE-listed parent (PSYG) entered an amalgamation agreement with a Ghanaian mining company in November 2025 (trading halted); the psychedelic R&D resides entirely in the separately-listed Nasdaq entity (PBM).
Reconnect Labs AG is a Swiss clinical-stage company and University of Zurich spin-off developing precision psychopharmacology therapeutics, including sublingual DMT/harmine, sublingual 5-MeO-DMT, and sublingual dexmedetomidine. Founded in 2021 by Dr. Davor Kosanic (CEO) and co-founders from the Psychiatric University Clinic Zurich and ETH Zurich, building on ~30 years of in-human psychedelic research. The company raised CHF 22M+ (CHF 12M equity across Seed 2021 and Series A 2023–2025; CHF 10M in competitive grants from investors including Esperante Ventures, Lionheart Ventures, Negev Capital, and Noetic Fund) before emerging from stealth in August 2025. Their microcarrier-based transmucosal delivery platform (exclusively licensed) dramatically reduces inter-subject PK variability for DMT/harmine vs. oral ayahuasca and eliminates vomiting. RE03 (sublingual dexmedetomidine for insomnia in PTSD) is the most advanced programme with Swissmedic approval and FDA accelerated pathway confirmed.
Reset Pharma is a US clinical-stage biotechnology company developing psilocybin-based treatments for patients with life-altering diseases. Its lead candidate RSTP1000 (oral psilocybin) targets demoralization syndrome in cancer patients — a condition with no approved treatments. In November 2023 the company received FDA IND clearance to initiate a Phase 2b multicenter, randomized, dose-ranging trial. The company holds an exclusive worldwide licence from NYU Langone Health and licenses drug supply from Filament Health Corp. Reset has raised $11.1M led by Merida Capital Partners.
Canadian biotech developing psilocybin formulations for substance use disorders and neurological conditions. Lead programme is an oral psilocybin thin-film strip in a Phase I/II clinical trial for methamphetamine use disorder, with approximately 50% enrolment completed. Also conducting preclinical research on psilocybin for stroke recovery and inflammation.
Seaport Therapeutics is a Boston-based biopharmaceutical company developing neuropsychiatric medicines using its proprietary Glyph™ lymphatic delivery platform. The Glyph technology bypasses first-pass hepatic metabolism by routing drugs through the lymphatic system, improving oral bioavailability. Its lead candidate SPT-348 (Glyph2BLSD™) is a prodrug of BOL-148 (2-bromo-LSD), a non-hallucinogenic neuroplastogen targeting headache disorders and TRD. The company raised $325M across a $100M Series A (2024) and $225M Series B (2024–2025), backed by PureTech Health, ARCH Venture Partners, Third Rock Ventures, and General Atlantic.
COMPASS Pathways plc (Nasdaq: CMPS) is a UK-headquartered clinical-stage biopharmaceutical company and the most advanced developer of a classic psychedelic medicine. Its lead asset, COMP360 — a synthetic, proprietary formulation of psilocybin — is being developed for treatment-resistant depression (TRD) delivered alongside a psychological-support model. COMP360 is the first psilocybin programme to complete two positive pivotal Phase 3 trials: COMP005 met its primary endpoint in June 2025 and the confirmatory COMP006 (two fixed doses given three weeks apart) did so in February 2026, with 26-week data reported in July 2026 confirming a rapid and durable antidepressant profile. In April 2026 the FDA granted a rolling NDA submission request and selected COMP360 for the Commissioner's National Priority Voucher programme, which carries a shortened review window. COMPASS has since begun that rolling submission and guides to a potential US launch in the first half of 2027, subject to approval, positioning it as the frontrunner for the first FDA-approved classic psychedelic therapy.
Definium Therapeutics (formerly Mind Medicine / MindMed) is a late-stage clinical biopharmaceutical company headquartered in New York, founded in 2019 and rebranded in January 2026. Led by CEO Robert Barrow, the company applies scientific rigor to psychedelic-derived molecules to develop accessible, rapidly-acting psychiatric treatments. Its lead asset, DT120 ODT (formerly MM-120) — a pharmaceutically optimised formulation of lysergide D-tartrate (LSD) as an orally disintegrating tablet — has received FDA Breakthrough Therapy Designation for generalised anxiety disorder (GAD) and delivered compelling Phase 2b results: 65% clinical response rate and 48% remission at 12 weeks following a single dose. Three Phase 3 trials are currently underway: Voyage and Panorama (GAD) and Emerge (MDD, fully enrolled). Topline data from all three studies is expected in 2026, potentially positioning Definium for the first-ever FDA approval of an LSD-derived therapy. A second pipeline asset, DT402 (formerly MM402) — an MDMA-related compound — is in Phase 1 development for autism spectrum disorder.
Eli Lilly and Company (NYSE: LLY) is one of the world's largest pharmaceutical companies, headquartered in Indianapolis, Indiana and founded in 1876, best known for its diabetes, obesity and neuroscience medicines. Lilly entered the psychedelic field in July 2026 by agreeing to acquire AtaiBeckley for up to approximately US$3.8 billion (US$6.75 per share in upfront cash, about US$2.8 billion, plus up to US$2.50 per share in milestone-based contingent value rights). Expected to close in the third quarter of 2026, the deal brings Lilly a late-stage psychedelic and neuroplastogen pipeline led by BPL-003, an intranasal formulation of mebufotenin (5-MeO-DMT) in Phase 3 for treatment-resistant depression, alongside VLS-01 (a DMT oral film) and EMP-01 (an oral (R)-MDMA candidate). It is the largest psychedelic-focused acquisition to date, though Lilly notably avoided the term "psychedelic" in its announcement.
GH Research plc (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company founded in 2018 and headquartered in Dublin, Ireland, developing novel mebufotenin (5-MeO-DMT) therapeutics for treatment-resistant depression, bipolar II disorder, and postpartum depression. Its lead asset GH001 — an inhaled mebufotenin formulation — met the primary endpoint of its Phase 2b TRD trial in February 2025 with striking results: -15.5 point MADRS reduction vs placebo (p<0.0001) and 57.7% remission vs 0%. With a single-day dosing paradigm requiring no structured psychotherapy, GH001 is positioned as a differentiated asset; Phase 3 global initiation is planned for 2026 following FDA clinical hold lift. GH002 (IV mebufotenin) completed Phase 1 in healthy volunteers. In July 2026, GH Research's principal competitor in the 5-MeO-DMT field, AtaiBeckley (developer of the intranasal mebufotenin candidate BPL-003 for treatment-resistant depression), agreed to be acquired by Eli Lilly for up to approximately US$3.8 billion, the largest psychedelic-focused acquisition to date. The deal hands a major pharmaceutical company a directly competing 5-MeO-DMT programme, sharpening the commercial and regulatory race around GH Research's inhaled GH001.
Helus Pharma is the commercial operating name of Cybin Inc., a clinical-stage biopharmaceutical company developing proprietary Novel Serotonergic Agonists (NSAs) — synthetic deuterated molecules designed to activate serotonin pathways and promote neuroplasticity. Operating across Canada, the US, UK, and Ireland, Helus holds over 100 granted patents and 250+ pending applications across its NSA portfolio. Its lead asset, HLP003 (formerly CYB003, a deuterated psilocin analogue), has received FDA Breakthrough Therapy Designation for the adjunctive treatment of major depressive disorder and is in two concurrent Phase 3 trials: APPROACH™ (topline data Q4 2026) and EMBRACE™. A key differentiator is its adjunctive design — allowing patients to continue background antidepressant medications without washout. HLP004 (a deuterated DMT analogue for intramuscular use) posted encouraging Phase 2 topline results in GAD in March 2026: 10.4-point HAM-A reduction at 6 weeks, 67% responders at 6 months, and an ~90-minute in-clinic session window. US composition-of-matter patent coverage through at least 2041.
Otsuka Pharmaceutical Co., Ltd. is a Japanese multinational pharmaceutical company (parent: Otsuka Holdings, TYO: 4578) with a core focus on neuropsychiatry, oncology, and cardiovascular/renal medicine. It entered the psychedelic medicine space by acquiring Canadian biotech Mindset Pharma for ~CAD $80M (~USD $59M) in September 2023, giving it exclusive rights to MSP-1014 and a broader pipeline of novel 5-HT2A agonists. The deal was seeded by an earlier $5M joint development agreement between Mindset and the McQuade Center for Strategic Research and Development (an Otsuka R&D vehicle). MSP-1014 is a Phase 2 psilocin prodrug for MDD, with trials underway in the UK. Otsuka has since widened its psychedelics involvement: in 2025 it announced a joint research agreement with Keio University on infrastructure for the social implementation of psychedelics in Japan, and in 2026 it completed the acquisition of Transcend Therapeutics, whose lead programme TSND-201 (methylone) is a rapid-acting neuroplastogen in development for PTSD.
Reunion Neuroscience is a private, Toronto-based clinical-stage biopharmaceutical company focused on short-duration, serotonergic psychedelic therapies for postpartum depression, adjustment disorder, and anxiety. Spun out of Field Trip Health in 2022, the company raised a $103M Series A in May 2024 (co-led by Novo Holdings and MPM BioImpact) and went private under CEO Greg Mayes. Its lead asset RE104 (luvesilocin) — a subcutaneous prodrug of 4-OH-DiPT, a psilocybin-like 5-HT2A agonist with shorter duration than psilocybin — met the primary endpoint of its RECONNECT Phase 2 trial for PPD (Aug 2025) and received FDA Breakthrough Therapy Designation on February 23, 2026. A single pivotal Phase 3 trial is planned for 2026.
Solvonis Therapeutics plc (LSE: SVNS) is a London-listed, clinical-stage biopharmaceutical company developing evidence-based treatments for addiction and mental health disorders. Formed through the rebranding of Graft Polymer (UK) PLC and the acquisition of Awakn Life Sciences Corp (NEO: AWKN, completed May 2025), Solvonis inherited Awakn's lead programme SVN-001 — IV ketamine combined with manualised CBT — now in Phase 3 for severe alcohol use disorder, co-funded by the UK NIHR. The company also advances SVN-002 (buccal/sublingual esketamine for US AUD) and SVN-SDN-14 (novel SDN receptor modulators for PTSD at preclinical stage), plus an AI-driven CNS discovery engine.
Tasman Therapeutics is a private US clinical-stage company developing R-107 — a once-daily oral extended-release ketamine tablet targeting treatment-resistant depression. A spinout of Douglas Pharmaceuticals (New Zealand's largest pharma company), Tasman operates as an independently financed US entity led by CEO Dan Browne (co-founder of Revance Therapeutics). Phase 2 BEDROC trial results published in Nature Medicine (March 2024): ~75% remission within one week, 6.1-point MADRS reduction vs. placebo at 12 weeks, median dissociation score of zero (no clinically significant dissociation), 90% continuance into OLE. A 106-patient compassionate supply cohort has taken R-107 at home for an average >2 years without dissociation or monitoring requirements. Phase 3 ROCKET Program (US, EU, international sites) is enrolment-ready; $175M Series A announced April 2025. FDA submission targeted 2027, potential commercialisation 2028. Peak sales projected >$2B.
Transcend Therapeutics is a private, New York-based clinical-stage company developing TSND-201 (methylone), a rapid-acting neuroplastogen for PTSD and other neuropsychiatric conditions. Founded in 2021 by Blake Mandell (CEO), Kevin Ryan (AlleyCorp), and Dr. Benjamin Kelmendi (Yale), the company raised $41.5M from investors including the US Department of Defense. TSND-201 is non-hallucinogenic (no 5-HT2A activity) and requires no structured psychotherapy. Its Phase 2 IMPACT-1 trial met the primary endpoint (March 2025, published JAMA Psychiatry Feb 2026) and the FDA granted Breakthrough Therapy Designation in July 2025. Phase 3 programme is planned for 2026.
Usona Institute is a US-based 501(c)(3) non-profit medical research organisation headquartered in Madison, Wisconsin. Usona develops and supports clinical research on psilocybin and other consciousness-expanding medicines with a mission-driven access model. Its psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study, Usona launched the Phase 3 uAspire trial in 2024, a 240-participant randomised, double-blind multicentre study of 25 mg psilocybin with psychosocial support for adults with MDD. In April 2026, industry reporting said Usona confirmed it had received an FDA Commissioner National Priority Voucher for psilocybin in MDD, potentially shortening review if an NDA is filed and accepted. Usona is also exploring 5-MeO-DMT in early-stage research.
NRx Pharmaceuticals is a US-based NASDAQ-listed biopharmaceutical company developing ketamine- and NMDA-targeted treatments for acute suicidal depression and related mood-disorder pathways. Its lead asset, NRX-100, is a preservative-free intravenous ketamine formulation for acute suicidal ideation in depression, including bipolar depression. The company is pursuing an NDA package based on completed controlled trials, expanded-access experience, and a large real-world evidence dataset. NRx reported in May 2026 that full NRX-100 NDA submission was expected in Q2 2026, supported by more than 1,000 clinical-trial participants and more than 65,000 real-world ketamine-treated patients. NRx also develops NRX-101, a fixed-dose D-cycloserine/lurasidone combination. The original programme targets oral maintenance treatment after ketamine stabilization in severe bipolar depression with acute suicidal ideation or behavior. In 2026, NRx also advanced a distinct NRX-101/TMS track as augmentation of accelerated transcranial magnetic stimulation, with FDA expanded-access clearance and the pivotal SPARC-TMS study initiated.
Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS as a commercial spinout to carry MAPS MDMA research through late-stage trials and regulatory approval. After two Phase 3 trials and an NDA filing, FDA issued a Complete Response Letter in August 2024 and requested an additional Phase 3 trial before approval. The company subsequently restructured and rebranded, while the public Lykos web presence continues to describe the organisation as pursuing FDA approval for MDMA-assisted therapy. As of the June 2026 review, no public company announcement of a new pivotal trial start or NDA resubmission date was found. VA/DoD-backed MDMA/PTSD research is proceeding in the broader field, but it should not be treated as direct support for Resilient/Lykos NDA resubmission unless linked by company or FDA evidence.
Johnson & Johnson is a publicly traded global healthcare company rather than a venture fund or dedicated asset manager. Its business spans pharmaceuticals and medical technology, and the company is based in New Brunswick, New Jersey, United States. In the psychedelic ecosystem, Johnson & Johnson matters mainly through its neuroscience and psychiatry-adjacent pharmaceutical activity rather than as a standalone investor. Its acquisition of Intra-Cellular Therapies, a CNS-focused biopharma, shows continued interest in neuropsychiatric therapeutics and related clinical-stage assets.
Canadian specialty pharmaceutical company focused on ketamine-based therapies for psychiatric and neurological conditions. KETARX™ (racemic ketamine IV) received FDA approval in August 2025, making PharmaTher one of the first Canadian companies to achieve US regulatory approval for a ketamine product. Also developing KETABET, a proprietary combination of ketamine and betaine.