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NCT06358651 · ClinicalTrials.gov record · last posted 2025-11-26

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)

Study acronym: PALISADE-3
StatusActive, Not Recruiting
PhasePhase 3
Started2024-03-28
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from the ClinicalTrials.gov record
This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study.

Amendment record 10 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 10 times since 2024-04-04; most recent amendment 2025-11-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-11-24
Status change Recruiting→Active, Not Recruitingv10
Trial Details
NCT Number NCT06358651
Lead Sponsor VistaGen Therapeutics, Inc.
Conditions Social Anxiety Disorder
Enrollment 238 participants
Start Date 2024-03-28
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-11-26