Clinical Research & Pipeline Products

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.

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.

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).

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.

Clinical-stage psychedelic company that also functions as a strategic-corporate capital allocator through legacy atai platform investments and deal activity in the sector.

UK-based biopharmaceutical company developing ketamine and esketamine-based treatments for alcohol use disorder and addiction. AWKN-001 (IV ketamine combined with cognitive behavioural therapy) is in Phase 3 clinical trials in the UK for alcohol use disorder. AWKN-002, an esketamine oral thin film formulation, is in pre-IND development for the US market.

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.

COMPASS Pathways is a UK-listed biopharmaceutical company developing COMP360 synthetic psilocybin therapy for treatment-resistant depression, with two successful Phase 3 trials making it the leading candidate for the first regulatory approval of a classic psychedelic medicine.

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.

Clearmind Medicine is an Israeli-American biotech developing CMND-100, a proprietary oral MEAI (5-methoxy-2-aminoindane) formulation for alcohol use disorder. First patient dosed in June 2025 in their multinational Phase 1/2a trial across Yale, Johns Hopkins, and Hadassah Medical Center. Positive first cohort top-line results reported November 2025.

UK-based specialist CNS and psychiatry-focused clinical research organization combining select CRO services, dedicated trial sites, participant recruitment, and psychedelic therapist training for complex mental-health studies.

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.

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.

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.

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.

Clinical-stage natural psychedelic drug development company with publicly announced Nagoya Protocol-compliant iboga import activity from Gabon for R&D and potential therapeutic development.

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.

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.

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.

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.

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.

The Ketamine Research Institute is a US-based clinical research organization developing precision medicine approaches to ketamine infusion therapy, studying optimized dosing protocols to treat depression and offering clinician training in evidence-based ketamine practice.

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.

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.

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.

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.

NRx Pharmaceuticals is a US-based NASDAQ-listed biopharmaceutical company developing NRX-100, a proprietary preservative-free formulation of intravenous ketamine, for the acute treatment of suicidal ideation in patients with depression including bipolar depression. Unlike most commercially available ketamine products, NRX-100 omits the benzethonium chloride preservative, whose safety profile in repeated dosing has not been established. Rather than running a traditional Phase 3 trial, NRx is pursuing NDA approval based on already-completed government-funded controlled trials (demonstrating 55–63% response/remission vs 30–31% for comparators), expanded access data, and — in a regulatory first — de-identified real-world evidence from over 70,000 US patients treated with IV or intranasal ketamine, licensed and submitted to the FDA in January 2026. The FDA granted Fast Track Designation to NRX-100 for suicidal ideation in depression in August 2025, and the company has applied for a Commissioner’s National Priority Voucher (CNPV) review, which could reduce review time to 1–2 months. The NDA filing is underway, with PDUFA date expected 2025–2026. A parallel generic pathway (KETAFREE™ ANDA) targets the broader ketamine market, with a Q2 2026 GDUFA date anticipated.

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.

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.

Numinus Wellness Inc. is a Vancouver-based mental health company focused on psychedelic-assisted therapy: it provides practitioner training, clinical research services, and (formerly) operated clinics and a Health Canada‑licensed bioscience laboratory for psychedelic research and product development.

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.

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.

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 (Multidisciplinary Association for Psychedelic Studies) as a commercial spinout to carry MAPS’ three decades of MDMA research through late-stage trials and regulatory approval. After completing two Phase 3 trials and filing an NDA in 2024, the FDA issued a Complete Response Letter (CRL) in August 2024, citing concerns about functional unblinding, durability of response, safety reporting at two trial sites, and the challenge of blinding psychedelic studies. The CRL requested a third Phase 3 trial. Following the rejection, the company laid off approximately 75% of staff. In May 2025, billionaire investors Antonio Gracias (Gracias Foundation) and Sir Christopher Hohn (TCI Fund) led a $50 million Series B recapitalisation, installing new leadership: CEO Mike Burke and CMO Javier Muniz. Rick Doblin, MAPS’ founder, remains supportive of the new direction. The company rebranded from Lykos Therapeutics to Resilient Pharmaceuticals on 28 August 2025, and continues to negotiate a path to FDA approval for MDMA-assisted therapy for PTSD.

Canadian biotech (formerly Nova Mentis Life Science, renamed November 2024) developing psilocybin therapy for Fragile X Syndrome and autism spectrum disorder. Lead candidate NM-1001 received Health Canada authorisation for a Phase IIA clinical trial, making it one of the few psilocybin programmes targeting neurodevelopmental conditions.

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.

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.

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.

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.

US clinical-stage biopharmaceutical company developing intranasal racemic ketamine (SLS-002) for major depressive disorder with acute suicidal ideation and PTSD. Completed Phase 2 trials before filing for Chapter 11 bankruptcy in November 2024 and being delisted from Nasdaq; trading continues on OTCQB.

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.

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.

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.

Australian biotech (formerly Tryp Therapeutics, relisted on ASX following Exopharm acquisition in May 2024) developing psilocybin and psilocin formulations for treatment-resistant conditions. TRP-8802 (oral psilocybin) completed Phase 2a trials for fibromyalgia and binge eating disorder. TRP-8803 (IV psilocin) has entered Phase 1 with first-in-human dosing.

Usona Institute is a US-based 501(c)(3) non-profit medical research organisation (MRO) headquartered in Madison, Wisconsin. Co-founded in 2014 by Bill Linton (CEO of Promega Corporation) and Malynn Utzinger, M.D., Usona was established after Linton witnessed the profound impact of a Johns Hopkins psilocybin study on a terminally ill friend. Unlike commercial drug developers, Usona operates as a mission-driven MRO — conducting and supporting pre-clinical and clinical research on psilocybin and other consciousness-expanding medicines, with the goal of developing accessible, affordable treatments. Its research leadership includes Dr. Charles Raison (Director of Clinical and Translational Research, UW-Madison psychiatrist) and Dr. Alexander Sherwood (medicinal chemist). Usona's psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study (the largest Phase 2 randomised controlled trial of psilocybin for MDD at the time), the Institute launched the Phase 3 uAspire trial in 2024 — a 240-participant, randomised, double-blind, multicentre study comparing 25 mg psilocybin vs placebo in adults with MDD. Usona is also exploring 5-MeO-DMT in early-stage research.

Xpira Pharmaceuticals is a Toronto-based private biotech developing psilocybin-assisted therapy for anorexia nervosa (AN), a condition with no currently approved pharmacological or psychotherapeutic treatments. Founded in 2020 by leaders from the Canadian and Dutch pharmaceutical industries, the company received FDA IND approval in September 2022 for a Phase 2a clinical trial. Xpira is a portfolio company of Origin Therapeutics Holdings. Dr. Allan Kaplan of CAMH and the University of Toronto serves as VP of Clinical Development.

Zylorion Health (formerly PsiloTec Health Solutions) is a Calgary-based biotech company developing integrated precision mental health therapies. Its proprietary Almond Therapy™ program combines psychedelic compounds with structured psychotherapy, and the company is advancing psilocybin-based clinical trials for treatment-resistant depression and PTSD alongside a novel second-generation psilocybin compound (ZYL-314) in its pipeline.