Definium Reports Positive Phase 3 Results for DT120 ODT in Generalized Anxiety Disorder

Definium Therapeutics, Inc. announced on September 14, 2026, that its Phase 3 Panorama study of DT120 Orally Disintegrating Tablet (ODT) for generalized anxiety disorder (GAD) met its primary and all key secondary efficacy endpoints. The study, which enrolled 245 participants across approximately 32 study centers, randomized subjects to receive a single dose of DT120 ODT 100 micrograms, 50 micrograms, or matching placebo.

The primary endpoint measured the change in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12. Participants receiving the 100 microgram dose of DT120 ODT showed a Least Squares (LS) mean change from baseline of -9.8, compared to -4.7 for the placebo group. This resulted in a placebo-adjusted difference of -5.1 points (p<0.0001). The drug demonstrated rapid efficacy, with changes observed as early as Day 2 and sustained through Week 12.

Key secondary endpoints also met statistical significance. The Clinical Global Impression-Severity (CGI-S) score showed an LS mean change of -1.0 for the 100 microgram group versus -0.5 for placebo. The study also reported response and remission rates, with 32% of DT120 ODT 100 microgram participants achieving a HAM-A response rate of 50% or greater at Week 12, compared to 14% in the placebo group.

Regarding safety, DT120 ODT 100 micrograms was generally well tolerated. The most common treatment-emergent adverse events (>10%) on the dosing day included illusion (68%), nausea (37%), and headache (24%). No new safety signals were identified, including no suicidality signal or drug-related serious adverse events. Overall discontinuation rates were similar across the treatment groups.

Definium stated that the Panorama results represent the second positive Phase 3 trial for DT120 ODT in GAD and the third positive readout for the drug overall, following positive results in major depressive disorder (MDD) and GAD. The company plans to hold a pre-NDA meeting with the FDA in the fourth quarter of 2026 and anticipates filing a New Drug Application (NDA) in the first half of 2027.