Clinical TrialMay 12, 2026, 08:17 AM
Definium Doses First Patient in Phase 3 MDD Study of DT120 ODT
AI Summary
Definium Therapeutics announced the dosing of the first patient in Ascend, its second Phase 3 pivotal study for DT120 ODT (lysergide tartrate) in Major Depressive Disorder (MDD). The study will evaluate the efficacy and safety of DT120 ODT against placebo, enrolling 175 participants in the U.S. This milestone follows positive Phase 2b results and positions the company for a pivotal period with anticipated topline data in 2027, aiming to address significant unmet needs in MDD treatment.
Key Highlights
- First patient dosed in Ascend, the second Phase 3 study of DT120 ODT for Major Depressive Disorder.
- DT120 ODT is Definium's proprietary formulation of lysergide tartrate (LSD).
- Primary endpoint measures change from baseline in MADRS score at Week 6 for 100 µg dose vs. placebo.
- The study is expected to enroll 175 participants in the United States.
- Topline data from the 12-week double-blind period is anticipated in 2027.
- Ascend builds on positive Phase 2b study results in generalized anxiety disorder.
- DT120 ODT is also being developed for generalized anxiety disorder and PTSD.
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