Business Wire·Sep 14, 2026, 7:00 AM ET

Definium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder

DFTX

Definium Therapeutics reported positive topline results from the Phase 3 Panorama trial of DT120 ODT for generalized anxiety disorder (GAD), marking the second positive Phase 3 study for DT120 in GAD and the third overall positive Phase 3 readout.
Participants receiving DT120 ODT 100 µg achieved a statistically significant reduction in HAM-A scores with a placebo-adjusted change of 5.1 points from baseline at Week 12 (p<0.0001, Cohen's d=0.64).
Efficacy was rapid, with significant changes observed as early as Day 2, and 94% of participants met end-of-session criteria by hour 8 in the treatment group.
DT120 ODT 100 µg demonstrated a dose-response relationship, with the 50 µg arm showing approximately 50% and 29% lower efficacy at Weeks 4 and 12, respectively, compared to the 100 µg arm.
The safety profile for DT120 ODT 100 µg was consistent with prior clinical experience, with most treatment-emergent adverse events being mild to moderate, transient, and occurring on the day of dosing.
No new safety signals were identified, including no suicidality signals or suicidal behavior, and there were no drug-related serious adverse events.
Common adverse events (>10%) on dosing day for the 100 µg arm included illusion (68%), nausea (37%), and headache (24%).
A pre-NDA meeting is scheduled for the fourth quarter of 2026, with an NDA filing anticipated in the first half of 2027.
Definium Therapeutics hosted a webcast at 8:00 a.m. EDT to review these findings, with a replay available on their investor relations website.