Definium Therapeutics reports positive Phase 3 Panorama results for LSD-derived DT120 ODT in generalized anxiety disorder

Definium Therapeutics reports positive topline results from Panorama, a randomized, double-blind Phase 3 study of DT120 ODT, its proprietary orally disintegrating formulation of lysergide (LSD), in adults with generalized anxiety disorder. Among 96 participants receiving a single 100 µg dose, HAM-A scores improved by 9.8 points at Week 12 versus 4.7 points with placebo, producing a statistically significant placebo-adjusted difference of 5.1 points, with Cohen's d=0.64. Key secondary endpoints also favored DT120, and efficacy appeared by Day 2. The treatment was generally well tolerated, although dosing-day adverse events included illusion, nausea, and headache. The study enrolled 245 participants and included a 50 µg control arm plus a long-term open-label extension. Definium plans a pre-NDA meeting in the fourth quarter of 2026 and anticipates filing an NDA in the first half of 2027, subject to regulatory and clinical risks.