Clinical TrialSep 14, 2026, 08:07 AM
Definium Therapeutics Announces Positive Phase 3 GAD Trial Results for DT120 ODT
AI Summary
Definium Therapeutics, Inc. announced positive topline results from its Phase 3 Panorama study of DT120 ODT for the treatment of generalized anxiety disorder (GAD). The study met its primary endpoint, demonstrating a statistically significant reduction in the Hamilton Anxiety Rating Scale (HAM-A) score compared to placebo. DT120 ODT was found to be generally well-tolerated, with a safety profile consistent with previous trials. The company has scheduled a pre-NDA meeting with the FDA for Q4 2026 and anticipates filing the NDA in the first half of 2027.
Key Highlights
- Definium Therapeutics announces positive topline data from Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder.
- Study met primary endpoint with statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score (p<0.0001).
- DT120 ODT 100 µg showed a placebo-adjusted change of 5.1 points in HAM-A score at Week 12.
- DT120 ODT was generally well tolerated with a safety profile consistent with prior clinical experience.
- Pre-NDA meeting scheduled for 4Q 2026; NDA filing anticipated in 1H 2027.
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