Trial Profile

US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-4)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 28 Nov 2025

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At a glance

24 Oct 2025 Planned End Date changed from 1 Oct 2026 to 1 Apr 2027.
02 Sep 2025 Planned primary completion date changed from 1 Oct 2025 to 1 Apr 2026.
07 Aug 2025 According to Vistagen media release, company believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the acute treatment of social anxiety in adults.

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