Definium Therapeutics announced positive topline results from its Phase 3 Voyage study evaluating DT120 ODT for the treatment of generalized anxiety disorder (GAD). The study successfully met its primary and all key secondary efficacy endpoints, demonstrating a statistically significant and clinically meaningful improvement in anxiety symptoms compared to placebo. The treatment was also found to be generally well tolerated.

Key Details

  • Primary Endpoint: The study met its primary endpoint with a statistically significant placebo-adjusted reduction of 5.4 points on the Hamilton Anxiety Rating Scale (HAM-A) at Week 12 (p<0.0001).
  • Safety Profile: DT120 ODT was generally well tolerated, with treatment-emergent adverse events being mild to moderate in severity. No new safety signals were identified.
  • Context & Outlook: This is the company's second positive Phase 3 readout for DT120 ODT. Topline results from a second pivotal GAD study, Panorama, are expected in September 2026.