DT120 ODT (Lysergide (LSD)) - (Emerge)

May 12, 2026: Definium Therapeutics, Inc. (NASDAQ: DFTX) announced first patient dosed in Ascend, its second Phase 3 randomized, double-blind, placebo-controlled trial evaluating DT120 Orally Disintegrating Tablet (DT120 ODT; lysergide tartrate) for major depressive disorder (MDD). Ascend is expected to enroll 175 U.S. participants and includes a 12-week blinded Part A followed by a 40-week open-label extension (Part B). Participants are randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg, or placebo; the 50 µg arm is intended to help maintain blinding. The primary endpoint is change from baseline in MADRS at Week 6 comparing DT120 ODT 100 µg vs placebo. Topline data from Ascend’s 12-week double-blind period is anticipated in 2027.

The release also notes Definium expects a topline readout (Part A results) from its first Phase 3 MDD study, Emerge, in late 2Q 2026, and states Ascend builds on positive Phase 2b results in generalized anxiety disorder that suggested potential antidepressant effects of DT120.