NCT06615557

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

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: Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: VistaGen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Social Anxiety Disorder (SAD)

Interventions

Type	Name	Description
DRUG	Fasedienol Nasal Spray	Nasal spray delivered 20 minutes before the PSC
DRUG	Placebo Nasal Spray	Nasal spray delivered 20 minutes before the PSC

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-09-26
• Last updated: 2026-02-05

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study