Vistagen Last Patient In PALISADE-3 Phase 3 Study Completes Trial For Evaluation Of Fasedienol To Treat Social Anxiety Disorder

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the last patient has completed 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 open label extension of the study is currently ongoing.

In August 2023, Vistagen reported positive results from its randomized, double-blind, placebo-controlled PALISADE-2 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder. The PALISADE-3 trial, and concurrent PALISADE-4 Phase 3 trial, involve the same public speaking challenge study design and primary efficacy endpoint as PALISADE-2, with certain protocol and operational enhancements related to site training, surveillance, and subject selection. The topline results for PALISADE-4 are anticipated in the first half of 2026.

Both PALISADE-3 and PALISADE-4 are designed to evaluate the efficacy and safety of a single dose of fasedienol in reducing anxiety symptoms during a simulated public speaking challenge in a clinical setting, using the Subjective Units of Distress Scale as the primary endpoint. PALISADE-3 subjects who choose to continue with the open label extension of the study can use fasedienol for up to twelve months in their daily lives. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fasedienol for the acute treatment of social anxiety disorder. Vistagen believes that either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, could provide substantial evidence of fasedienol's effectiveness to support a potential New Drug Application (NDA) submission to the FDA for the acute treatment of social anxiety disorder.