VistaGen reports positive open-label extension data from PALISADE-4 Phase 3 trial of fasedienol in social anxiety disorder
VTGN•Next regulatory step
Management plans an FDA meeting this quarter to discuss a proposed new registrational Phase 3 trial.
PALISADE-4 extension data show sustained safety and improvement
VistaGen released preliminary positive open-label extension data from the PALISADE-4 Phase 3 study of fasedienol for social anxiety disorder.
Results were already presented from a July 24, 2026 cut of patients using the nasal spray as needed.
The safety profile held up with no new drug-related concerns during up to 12 months of real-world, repeated use.
Exploratory measures showed sustained improvement in social anxiety severity over four months on clinician-rated and patient-reported assessments.
