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NCT06615557 · ClinicalTrials.gov record · last posted 2026-05-22

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Study acronym: PALISADE-4
StatusActive, Not Recruiting
PhasePhase 3
Started2024-09-16
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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-4 and choose to enter the distinct open-label extension phase of the study.

Protocol amendment history 1 change detected by DataLookout

2026-05-23
Trial status changed: Recruiting → Active, Not Recruiting
Trial Details
NCT Number NCT06615557
Lead Sponsor VistaGen Therapeutics, Inc.
Conditions Social Anxiety Disorder (SAD)
Enrollment 238 participants
Start Date 2024-09-16
Primary Completion 2026-04-21 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-22