Clinical TrialJun 9, 2026, 05:06 PM
Vistagen Fasedienol Program Meets ICH E1 Safety Exposure Recommendations
AI Summary
Vistagen Therapeutics announced its fasedienol nasal spray clinical program for social anxiety disorder achieved minimum patient exposures under ICH E1 safety recommendations. As of May 31, 2026, over 1,500 subjects received at least one dose, with over 300 having 6-month and over 100 having 12-month exposures. The company expects topline results from its PALISADE-4 Phase 3 trial in Q2 2026 and Phase 2 Repeat Dose study in Q3 2026, which, if successful, could support a U.S. NDA submission. Fasedienol has Fast Track designation and a differentiated mechanism of action.
Key Highlights
- Vistagen's fasedienol program met ICH E1 minimum safety exposure recommendations.
- Over 1,500 subjects received at least a single exposure to fasedienol as of May 31, 2026.
- Over 300 subjects achieved at least 6-months of fasedienol exposure.
- Over 100 subjects achieved at least 12 months of fasedienol exposure.
- Topline results for PALISADE-4 Phase 3 trial expected in Q2 2026.
- Topline results for Phase 2 Repeat Dose study expected in Q3 2026.
- Fasedienol has FDA Fast Track designation for acute treatment of social anxiety disorder.
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