Definium TherapeuticsNASDAQ: DFTX
Also known as: MindMed, Mind Medicine, Mind Medicine (MindMed) Inc.
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.
Development Programmes
3DT120 (MM-120)
LSDLysergide 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.
Programme Tracker
Anxiety Disorders
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 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
Dec 17, 2024: Phase III started
Anxiety Disorders
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
Recruiting - Phase III - Dec 11, 2024
Recruiting - Phase III - Jan 29, 2025
Completed - Phase II - Jun 27, 2022
Related Papers
Evidence Links
Regulatory filing - Definium Therapeutics - Mar 7, 2024 - Verified
FDA BTD based on Phase 2b 12-week durability data showing 65% response and 48% remission
Press release - Business Wire - Dec 14, 2023 - Verified
Phase 2b topline: dose-dependent HAM-A reductions, 100µg selected for Phase 3
Publication - JAMA - Oct 21, 2025 - Verified
Full Phase 2b results published in JAMA — first RCT of LSD for GAD
Press release - Business Wire - Jan 9, 2026 - Verified
Rebrand from MindMed to Definium; NASDAQ ticker changed to DFTX
Conference - Yahoo Finance - Mar 16, 2026 - Verified
Management previews Phase 3 program progress at Leerink Partners conference
DT120 (MM-120) — MDD
LSDSame 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.
Programme Tracker
Major Depressive Disorder (MDD)
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
Recorded Events
Apr 14, 2025: Phase III started
Major Depressive Disorder (MDD)
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
Recruiting - Phase III - Apr 14, 2025
Related Papers
Evidence Links
Press release - Business Wire - Apr 14, 2025 - Verified
Press release - Business Wire - Feb 26, 2026 - Verified
Confirms Emerge fully enrolled, Ascend initiating mid-2026, cash runway into 2028
DT402 (MM402)
MDMAR(-)-MDMA (R-enantiomer of MDMA), Definium's proprietary entactogen. Phase 1 SAD study in healthy volunteers completed Oct 2024. Phase 2a open-label study in up to 20 adults with ASD initiated Q4 2025; assessing pharmacodynamics and clinical effects on core socialization and communication symptoms. Initial data expected 2026.
Programme Tracker
Autism Spectrum Disorder (ASD)
Forecast
Phase II topline - Likely: Q4 2026 - Conditional: 35% - Approval eventual: 10%
Open-label Phase 2a in up to 20 adults with ASD; initial data expected 2026
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
Recruiting - Phase II - Dec 3, 2025
Evidence Links
Conference - MindMed - Jun 1, 2023 - Verified
Preclinical activity data for R-MDMA presented at ASCP annual meeting
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
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