VistaGen Completes Phase 3 Trial of Fasedienol for Social Anxiety Disorder

Reuters11-03
VistaGen Completes Phase 3 Trial of Fasedienol for Social Anxiety Disorder

VistaGen Therapeutics Inc. announced the completion of the randomized, double-blind, placebo-controlled portion of the PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder. The trial used a public speaking challenge study design to assess the efficacy and safety of a single dose of fasedienol, with the Subjective Units of Distress Scale as the primary endpoint. The open-label extension of the study is ongoing, allowing subjects to use fasedienol for up to twelve months. Topline results from PALISADE-3 are expected later this quarter. The company previously reported positive results from the PALISADE-2 Phase 3 trial and anticipates topline results from the PALISADE-4 Phase 3 trial in the first half of 2026. The FDA has granted Fast Track designation for fasedienol in this indication.

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