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A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Study sites: 6 to 9v6
  3. Study sites: 5 to 6v5
  4. Primary completion date: Dec 2025 to Apr 2026 Site details revised at 1 of 5 sitesv4 Show 1 more changeShow less
    • Site details revised at 1 of 5 sites
  5. Study sites: 3 to 5 Study title shortened, about 5 wordsv3 Show 1 more changeShow less
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 2 to 3v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose 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 PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.
Trial Details
NCT Number NCT06809179
Lead Sponsor VistaGen Therapeutics, Inc.
Conditions Social Anxiety Disorder
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov