DT120 ODT (MM120) (lysergide D-tartrate, LSD) - (Voyage)
- Indication
- Generalized Anxiety Disorder (GAD)
- Stage
- phase3
- Event
- Topline Data
- Details
August 12, 2026: Definium Therapeutics (NASDAQ: DFTX) reported positive topline results from Voyage, its first pivotal Phase 3 trial of DT120 (lysergide) orally disintegrating tablet 100 µg in adults with generalized anxiety disorder. The 214-patient, randomized, placebo-controlled study met its primary endpoint and all key secondary endpoints.
At Week 12, DT120 achieved an LS mean HAM-A change of -11.6 versus -6.2 for placebo, for a placebo-adjusted difference of -5.4 points (p<0.0001; Cohen’s d=0.81). Key secondary endpoints also favored DT120: CGI-S change at Week 12 was -1.0 vs -0.4 (difference -0.6; p<0.0001), HAM-A change at Week 1 was -11.9 vs -4.2 (difference -7.7; p<0.0001), and CGI-S change at Day 2 was -1.0 vs -0.2 (difference -0.8; p<0.0001). Week 12 response rate was 43% vs 16%, remission 14% vs 4%, and mild-or-better anxiety 51% vs 23%.
DT120 was generally well tolerated; adverse events were mostly mild to moderate, transient, and mainly on dosing day, with no new safety signals and no suicidality signal. Definium said Panorama, its second Phase 3 GAD study, is expected to report topline results in September.
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