Definium DT120 succeeds in Phase 3 anxiety trial

• Definium Therapeutics (NASDAQ:DFTX) reported positive Phase 3 Panorama results for DT120 ODT in adults with generalized anxiety disorder (GAD).
• DT120 ODT achieved a placebo-adjusted 5.1-point improvement in HAM-A score at Week 12, with statistical significance and a Cohen’s d effect size of 0.64.
• The company plans a pre-NDA meeting with the FDA in Q4 2026 and expects to file a New Drug Application in the first half of 2027.

Definium Therapeutics (NASDAQ:DFTX) reported positive topline results from the Phase 3 Panorama study evaluating DT120 (lysergide) Orally Disintegrating Tablet in adults with generalized anxiety disorder.

The study met its primary endpoint and all key secondary efficacy endpoints, marking the second positive Phase 3 trial for DT120 ODT in GAD and the third positive Phase 3 readout for the program.

Patients receiving DT120 ODT 100 micrograms achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) scores compared with placebo.

At Week 12, the least squares mean change from baseline was -9.8 points for DT120 ODT compared with -4.7 points for placebo, resulting in a placebo-adjusted difference of -5.1 points (p<0.0001).

The result corresponded to a standardized effect size of Cohen’s d=0.64, indicating a clinically meaningful treatment effect.

Definium said improvements appeared as early as Day 2 and were maintained throughout the study period.

The safety profile of DT120 ODT was generally consistent with previous clinical experience.

Across the Phase 3 program, including more than 1,000 treatment sessions through September 10, 2026, 97% of participants met structured end-of-session checklist criteria by hour eight.

The company plans to hold a pre-New Drug Application meeting with the U.S. Food and Drug Administration in the fourth quarter of 2026, with an NDA filing anticipated during the first half of 2027.