Definium Therapeutics' Lysergide-Based DT120 ODT Achieves Landmark Phase 3 Success in Generalized Anxiety Disorder
On August 12, 2026, Definium Therapeutics (formerly MindMed) announced positive topline results from its first Phase 3 trial "Voyage" evaluating DT120 (lysergide tartrate) Orally Disintegrating Tablet (ODT) 100 µg in adults with generalized anxiety disorder (GAD). The trial met its primary endpoint and key secondary endpoints, demonstrating that a single dose of the psychedelic compound could provide rapid, durable, and highly significant relief from anxiety symptoms.
Landmark Clinical Efficacy and Safety Profile
The 214-patient Voyage trial pitted a single 100 µg dose of DT120 ODT against a placebo. At Week 12, patients treated with DT120 ODT experienced a highly significant reduction in anxiety symptoms:
- Primary Endpoint: A Week 12 Hamilton Anxiety Rating Scale (HAM-A) least-squares mean change of -11.6 points for DT120 ODT versus -6.2 points for placebo.
- Effect Size: This represents a placebo-adjusted difference of -5.4 points (p<0.0001, Cohen’s d=0.81), which is more than double the standard-of-care effect size typically seen with benzodiazepines, buspirone, or selective serotonin reuptake inhibitors (SSRIs).
- Onset and Durability: Clinically meaningful improvements emerged as early as Day 2 and were consistently maintained across all assessed timepoints up to Week 12.
- Safety: DT120 ODT was generally well tolerated. Most treatment-emergent adverse events (TEAEs) were mild to moderate, transient, and occurred primarily on the day of dosing. Crucially, there were no serious adverse events (SAEs) reported in Part A and no suicidality signal or suicidal behavior was observed.
Next Steps and Upcoming Catalyst
This readout represents Definium's second positive Phase 3 success for DT120, following the positive "Emerge" results in major depressive disorder (MDD) announced in June 2026.
Definium is conducting a second pivotal Phase 3 GAD study called Panorama (NCT06809595), which is designed to evaluate a single 100 µg dose of DT120 ODT compared to both placebo and a low-dose 50 µg arm (the latter included to address potential functional unblinding and align with FDA guidance). Topline results from the Panorama trial are anticipated in September 2026, paving the way for a potential dual GAD and MDD regulatory filing.