DT120 ODT (MM120) lysergide tartrate - (Panorama)
- Indication
- Generalized Anxiety Disorder (GAD)
- Stage
- phase3
- Event
- Submission
- Details
September 14, 2026: Definium Therapeutics (NASDAQ: DFTX) reported positive topline results from Panorama (MM120-301), its second Phase 3 trial of DT120 orally disintegrating tablet (lysergide ODT) in adults with generalized anxiety disorder. The study met the primary endpoint and all key secondary endpoints, and the company said this is the third positive Phase 3 readout for DT120 ODT overall.
At Week 12, DT120 ODT 100 µg achieved a least-squares mean HAM-A change of -9.8 versus -4.7 for placebo, a placebo-adjusted difference of -5.1 points (p<0.0001; Cohen’s d=0.64). Key secondary endpoints were also significant: CGI-S at Week 12 (-1.0 vs -0.5; difference -0.6, p<0.0001), HAM-A at Week 1 (-9.8 vs -4.5; difference -5.3, p<0.0001), and CGI-S at Day 2 (-1.1 vs -0.3; difference -0.8, p<0.0001). Response, remission, and “mild or better” rates at Week 12 also favored DT120.
DT120 100 µg was generally well tolerated, with no new safety signals, no suicidality signal, and no drug-related serious adverse events. Common dosing-day TEAEs were illusion, nausea, and headache.
Upcoming regulatory catalysts: a pre-NDA meeting is scheduled for 4Q 2026, and NDA filing is anticipated in 1H 2027.
- Source
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