Definium's LSD-based drug clears bar in first Phase 3 anxiety disorder trial

Definium Therapeutics has announced positive topline results from Voyage, the first Phase 3 trial of its LSD-based drug DT120 ODT 100 µg in adults with generalized anxiety disorder (GAD).

The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12, with a placebo-adjusted change of 5.4 points (p<0.0001) and effect size d=0.81.

DT120 ODT was well tolerated, with mostly mild to moderate, transient adverse events occurring on the day of dosing and no new safety signals, including no suicidality signal or suicidal behavior.

This is the second positive Phase 3 readout for DT120, following a prior success in major depressive disorder (MDD) in the Emerge study.

The second Phase 3 GAD trial, Panorama, is fully enrolled and expected to read out in September 2026; it includes a 50 µg low-dose arm in addition to the 100 µg dose and placebo.