Helus Pharma
Phase III2 active candidates6 trials
2 shared indicationsPhase III peer2 overlapping stagessame regulator: US FDA
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Lead program: Phase III
Definium TherapeuticsNASDAQ: DFTX
Also known as: MindMed, Mind Medicine, Mind Medicine (MindMed) Inc.
Data updated
3 Drug Candidates8 Trials1 Patent
Enterprise Intelligence
Quarterly psychedelic drug-development briefing
Compare indication activity, programme milestones, competitive intensity, and near-term catalysts. Q2 includes quarter-over-quarter changes against the published Q1 baseline.
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.
Ecosystem
1 connectionInvestors
Kevin O'Leary
Seed
Jan 1, 2020
undisclosed
Mind Medicine: Why Kevin O'Leary Thinks This Psychedelics Company Is Just Getting StartedOwnership & corporate history
1How this organisation and its programmes changed hands
- Renamed9 January 2026
Mind Medicine (MindMed) rebranded as Definium Therapeutics, trading on Nasdaq as DFTX from 13 January 2026; lead asset MM-120 was renamed DT120.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 3
- Active programmes
- 5
- Lead stage
- Phase III
- Forecast coverage
- 5 of 5
All tracked candidates active
All tracked programmes active
Multiple active stages
5 active programmes with forecast fields
Latest sourced update
Definium announces positive Phase 3 Emerge topline results for DT120 ODT in MDD
Jun 22, 2026 - Press release - Definium Therapeutics - DT120 (MM-120) — MDD
Next known catalyst
Phase III topline
Q2 2026 - DT120 (MM-120) — MDD / Emerge (MDD Phase 3) - Confidence: 60%
15 sources5 pipeline-linked trials1 pipeline-linked paper2 Phase III1 Phase II
Development Programmes
3DT120 (MM-120)
LSDPhase III
Lysergide D-tartrate (LSD) orally disintegrating tablet (ODT), Catalent Zydis fast-dissolve technology. Single-session administration. FDA Breakthrough Therapy Designation for GAD (March 2024). Phase 2b (NCT05407064): dose-dependent HAM-A reduction, 65% clinical response, 48% remission at 12 weeks after single 100µg dose. Three Phase 3 trials underway with topline data expected throughout 2026.
Anxiety Disorders
Primary: US (FDA)
Phase IIIActive
Forecast
Phase III topline - Likely: Q3 2026 - Conditional: 65% - Approval eventual: 45%
Enrollment ~80% complete as of Feb 2026; topline data expected early Q3 2026
Milestones
Phase II publication
CompletedActual: Sep 4, 2025
JAMA published the Phase 2b GAD trial of MM120 (lysergide): a multicentre, randomised, double-blind, placebo-controlled study in 198 adults with moderate-to-severe GAD across 22 US sites, showing a significant dose-response on HAM-A change at Week 4, best at 100 micrograms, the dose carried into Phase 3.
Why it matters: Peer-reviewed anchor for the GAD programme that underpins the Voyage and Panorama Phase 3 trials.
Phase III started
CompletedActual: Dec 17, 2024
First patient dosed in Voyage — first-ever Phase 3 LSD trial for GAD
Why it matters: Initiates pivotal program that could lead to first FDA-approved LSD therapy
Watch next: Enrollment completion expected Q1 2026
Phase III topline
PlannedLikely: Q3 2026
Topline data expected early Q3 2026 per company guidance
Why it matters: First of three Phase 3 readouts — if positive, strongest catalyst for NDA pathway
Watch next: Enrollment completion announcement, then ~12-week treatment period before readout
Recorded Events
Sep 4, 2025: Phase II publication
Dec 17, 2024: Phase III started
Anxiety Disorders
Primary: US (FDA)Follow-on: EU (EMA)
Phase IIIActive
Forecast
Phase III topline - Likely: Q4 2026 - Conditional: 60% - Approval eventual: 40%
Enrollment rapidly progressing; includes US and European sites. Topline data expected H2 2026.
Milestones
Phase III started
CompletedActual: Mar 1, 2025
First patient dosed in Panorama — second pivotal GAD study, includes 50µg and 100µg arms
Why it matters: Two-dose design strengthens the NDA package by controlling for expectancy effects
Watch next: Full enrollment, then topline data H2 2026
Phase III topline
PlannedLikely: Q4 2026
Topline data expected H2 2026
Why it matters: Second pivotal GAD study — positive result plus Voyage would complete Phase 3 GAD package
Watch next: Full enrollment announcement
Recorded Events
Mar 1, 2025: Phase III started
Related Trials
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
Active not recruiting - Phase III - Dec 11, 2024
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
Active not recruiting - Phase III - Jan 29, 2025
A Dose-Finding Study of MM-120 for the Treatment of Anxiety Symptoms
Completed - Phase II - Aug 24, 2022
Related Papers
Evidence Links
FDA Grants Breakthrough Therapy Designation for MM120 in GAD
Regulatory filing - Definium Therapeutics - Mar 7, 2024 - Verified
FDA BTD based on Phase 2b 12-week durability data showing 65% response and 48% remission
MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in GAD
Press release - Business Wire - Dec 14, 2023 - Verified
Phase 2b topline: dose-dependent HAM-A reductions, 100µg selected for Phase 3
Single Treatment With MM120 (Lysergide) in GAD — JAMA Publication
Publication - JAMA - Oct 21, 2025 - Verified
Full Phase 2b results published in JAMA — first RCT of LSD for GAD
MindMed Rebrands to Definium Therapeutics — Three Phase 3 Readouts Expected in 2026
Press release - Business Wire - Jan 9, 2026 - Verified
Rebrand from MindMed to Definium; NASDAQ ticker changed to DFTX
Definium Teases Phase III DT120 Data at Leerink Conference
Conference - Yahoo Finance - Mar 16, 2026 - Verified
Management previews Phase 3 program progress at Leerink Partners conference
DT120 (MM-120) — MDD
LSDPhase III
Same LSD ODT formulation as GAD programme. Two Phase 3 studies in major depressive disorder: Emerge (fully enrolled, topline late Q2 2026) and Ascend (initiating mid-2026). Primary endpoint: MADRS score change at Week 6. First-ever Phase 3 LSD trials in MDD.
Major Depressive Disorder (MDD)
Primary: US (FDA)
Phase IIIActive
Forecast
Phase III topline - Likely: Q2 2026 - Conditional: 50% - Approval eventual: 30%
Fully enrolled (~140 pts). Topline data expected late Q2 2026.
Milestones
Phase III started
CompletedActual: Apr 14, 2025
First patient dosed in Emerge — first-ever Phase 3 LSD trial for MDD
Why it matters: Opens a new indication beyond GAD; MDD is a much larger market
Watch next: Full enrollment, then topline data
Phase III topline
PlannedLikely: Q2 2026
Fully enrolled as of early 2026; topline expected late Q2 2026
Why it matters: First Phase 3 LSD data in MDD — if positive, opens second NDA pathway
Watch next: Topline press release expected Q2 2026
Phase III topline
CompletedActual: Jun 22, 2026
Positive topline from the Phase 3 EMERGE study of DT120 orally disintegrating tablet in MDD: a placebo-adjusted MADRS change of 8.1 points at Week 6 (DT120 −13.3 vs placebo −5.2 LS mean, p<0.0001), separation as early as Week 1, and benefit sustained to Week 12; Week 6 response 35% vs 7% and remission 24% vs 3%, with no serious adverse events or suicidality signal.
Why it matters: First Phase 3 efficacy readout for the DT120 ODT in depression, a large and rapid effect.
Recorded Events
Jun 22, 2026: Phase III topline
Apr 14, 2025: Phase III started
Major Depressive Disorder (MDD)
Primary: US (FDA)
Phase IIIActive
Forecast
Phase III started - Likely: Q2 2026
Sites activated; first patient dosing anticipated early Q2 2026. ~175 pts (2:1:2 randomization: 100µg, 50µg, placebo).
Milestones
Phase III started
PlannedLikely: Q2 2026
Ascend initiation accelerated — first patient dosing anticipated early Q2 2026
Why it matters: Second pivotal MDD study; includes 50µg dose arm for dose-response data
Watch next: First patient dosed announcement
Related Trials
A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)
Active not recruiting - Phase III - Apr 14, 2025
Related Papers
Evidence Links
MindMed Announces First Patient Dosed in Phase 3 Emerge Study in MDD
Press release - Business Wire - Apr 14, 2025 - Verified
Definium Reports Full-Year 2025 Financial Results and Business Updates
Press release - Business Wire - Feb 26, 2026 - Verified
Confirms Emerge fully enrolled, Ascend initiating mid-2026, cash runway into 2028
Definium announces positive Phase 3 Emerge topline results for DT120 ODT in MDD
Press release - Definium Therapeutics - Jun 22, 2026 - Verified
Release reports the Phase 3 Emerge study met primary and key secondary endpoints for DT120 ODT in major depressive disorder, providing a current freshness-window source.
DT402 (MM402)
MDMAPhase II
R(-)-MDMA (R-enantiomer of MDMA), Definium proprietary entactogen. ClinicalTrials.gov lists the Phase 2a ASD study NCT07303907 as recruiting, with 20 estimated participants, actual start on 2025-12-03, last update posted 2026-04-06, and primary completion expected August 2027.
Autism Spectrum Disorder (ASD)
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline - Likely: Q4 2027 - Conditional: 35% - Approval eventual: 10%
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.
Milestones
Phase I completed
CompletedActual: Oct 1, 2024
Phase 1 single-ascending dose study in healthy volunteers completed
Why it matters: Established safety and PK/PD profile of R-MDMA, enabling Phase 2a
Watch next: Phase 2a initiation
Phase II started
CompletedActual: Oct 1, 2025
Phase 2a study initiated in Q4 2025; first participant dosed
Why it matters: First clinical study of R-MDMA in ASD — tests whether prosocial effects translate to therapeutic benefit
Watch next: Initial data readout expected 2026
Phase II topline
PlannedLikely: Q4 2026
Initial Phase 2a data in ASD expected 2026
Why it matters: Will determine if R-MDMA shows signal in ASD, informing larger Phase 2b/3 plans
Watch next: Data readout announcement
Recorded Events
Oct 1, 2025: Phase II started
Oct 1, 2024: Phase I completed
Related Trials
A Phase 2A Trial of MM402 for Autism Spectrum Disorder
Recruiting - Phase II - Dec 3, 2025
Evidence Links
MindMed Presents Preclinical Data on MM-402 at ASCP 2023
Conference - MindMed - Jun 1, 2023 - Verified
Preclinical activity data for R-MDMA presented at ASCP annual meeting
Investigator-Initiated Phase 1 Comparative PK/PD Trial of R-, S- and Racemic MDMA (Basel)
News / media - Psychedelic Alpha - Jan 1, 2023 - Verified
NCT05277636 — Investigator-initiated crossover study at University Hospital Basel comparing R-MDMA, S-MDMA, racemic MDMA in healthy subjects
ClinicalTrials.gov NCT07303907 - DT402 Phase 2a ASD study
clinical-trial-registry - ClinicalTrials.gov - Apr 6, 2026 - Verified
Registry lists recruiting status, 20 estimated participants, actual start 2025-12-03, and primary completion expected August 2027.
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Quick Facts
- Type
- Public Biotech
- Founded
- 2019
- Ticker
- NASDAQ: DFTX
- Lead Stage
- Phase III
- HQ
- One World Trade Center, Suite 8500, New York, NY, United States
- Website
- Visit
Research Landscape
What the registered trials Definium Therapeutics sponsors or participates in look like when you line them up. Counts come from Blossom’s trial records as of August 2026.
What's live right now, and what stopped?
SourcedRegistry status of all 8 Definium Therapeutics trials Blossom tracks. Orange marks trials recruiting or opening.
Don't read stopped trials as failures: trials end early for funding, recruitment, and strategy reasons too. Status is as last synced from the registry; some 'recruiting' trials may already have finished.
Sponsored Trials
8RecruitingIII
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
- Start Date
- Compounds
- Placebo, LSD
RecruitingII
A Phase 2A Trial of MM402 for Autism Spectrum Disorder
- Start Date
- Compounds
- MDMA
Active not recruitingIII
A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)
- Start Date
- Compounds
- Placebo, LSD
Active not recruitingIII
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
- Start Date
- Compounds
- Placebo, LSD
Active not recruitingIII
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)
- Start Date
- Compounds
- Placebo, LSD
CompletedII
A Dose-Finding Study of MM-120 for the Treatment of Anxiety Symptoms
- Start Date
- Compounds
- Placebo, LSD
CompletedII
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
- Start Date
- Compounds
- Placebo, LSD
CompletedI
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
- Start Date
- Compounds
- Ibogaine
Where this pipeline sits in the field
Definium Therapeutics runs late-stage trials that Blossom ranks by how soon a catalyst is expected, alongside every other Phase 2 and Phase 3 study in the field.
Patents
1Recent activity
- NewsDefinium Therapeutics reported positive topline results from its Phase 3 study of LSD (DT120) in generalised anxiety disorder, meeting primary and key secondary endpoints.Psychedelic Alpha
- FieldDefinium closed an upsized US$805 million public offeringDefinium Therapeutics
- FieldDefinium reported Phase 3 Emerge topline results for DT120 in depressionDefinium Therapeutics
- ProgrammePositive topline from the Phase 3 EMERGE study of DT120 orally disintegrating tablet in MDD: a placebo-adjusted MADRS c…
- StartedA Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) (NCT07592689, lsd)
- StartedA Phase 2A Trial of MM402 for Autism Spectrum Disorder (NCT07303907, mdma)
- StartedA Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge) (NCT06941844, lsd)
- StartedA Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama) (NCT06809595, lsd)