Definium Therapeutics reports positive Phase 3 Panorama results for DT120 ODT in anxiety disorder

  • Definium Therapeutics reported positive Phase 3 Panorama results for DT120 ODT in generalized anxiety disorder.
  • DT120 ODT reduced HAM-A scores 9.8 points versus 4.7 points for placebo at Week 12.
  • Definium plans an FDA pre-NDA consultation in late 2026 and expects a first-half 2027 filing.

Definium Therapeutics reported that its LSD-derived drug candidate DT120 Orally Disintegrating Tablet (ODT) achieved statistically significant anxiety relief in the Phase 3 Panorama trial, its third consecutive Phase 3 success. The study evaluated a single 100-microgram dose of lysergide in 245 adults with generalized anxiety disorder across 32 centers. At Week 12, HAM-A scores fell 9.8 points from baseline versus 4.7 points for placebo, producing a 5.1-point placebo-adjusted difference and an effect size of 0.64. The trial met its primary endpoint and all designated secondary efficacy measures, with separation from placebo emerging by Day 2 and persisting through the study. A 50-microgram arm was included to assess functional unblinding; participants could distinguish active treatment from placebo at both doses, while the 100-microgram dose delivered stronger efficacy. Safety findings were consistent with earlier studies, with mostly mild-to-moderate, transient adverse events and discontinuation rates of 10.4% for DT120 ODT and 10.3% for placebo. Across more than 1,000 Phase 3 treatment sessions through September 10, 2026, about 97% of participants met end-of-session discharge criteria within eight hours. The Panorama data follow positive Voyage results in generalized anxiety disorder and Emerge results in major depressive disorder, where a single 100-microgram dose produced an 8.1-point improvement over placebo at Week 6, sustained through Week 12. DT120 ODT has FDA Breakthrough Therapy designation for both anxiety and depression. Definium plans a pre-New Drug Application consultation with the FDA in the fourth quarter of 2026 and expects to file in the first half of 2027. Shares rose roughly 20% in Monday premarket trading after the announcement; the stock had closed Friday at $38.89 and gained 303% over the previous year.

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