Definium Advances DT120 ODT With Three Readouts, Phase 3 PTSD Trial
Definium Therapeutics said its DT120 ODT program will deliver three topline readouts for MDD and GAD in the next six months, with two trials fully enrolled and Phase 2 and 2b studies underway. The company will initiate a Phase 3 Haven PTSD trial in 2027 and preparing a commercial strategy.
1. DT120 ODT Clinical Advancements
Definium’s DT120 ODT program includes four pivotal studies: Emerge (149 participants, fully enrolled, topline data due late 2Q 2026), Ascend (sites activated, first dosing expected 2Q 2026), Voyage (214 participants, fully enrolled, topline data due early 3Q 2026) and Panorama (screening closed with over 200 participants, topline now late 3Q 2026).
2. Phase 3 Haven PTSD Study
The Company plans to initiate the Phase 3 Haven study in 2027, aiming to enroll approximately 200 participants randomized 1:1 to DT120 ODT or placebo, with the primary endpoint measured by the CAPS-5 scale at Week 8 to assess efficacy in posttraumatic stress disorder.
3. Commercial Strategy and Market Opportunity
Definium is building a scalable delivery model and preparing access and reimbursement pathways to support efficient adoption and long-term utilization of DT120 ODT. Management highlights a potential multi-billion-dollar opportunity across depression, anxiety and trauma, backed by a multi-layered IP strategy on composition, formulation and methods of use.