NCT06809179 · ClinicalTrials.gov record · last posted 2026-02-05
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
Started2025-01-09
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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.
from the ClinicalTrials.gov record
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.
Amendment record
6 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 6 times since 2025-01-29; most recent amendment 2026-02-03. 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 ↗
| NCT Number |
NCT06809179 |
| Lead Sponsor |
VistaGen Therapeutics, Inc.
|
| Conditions |
Social Anxiety Disorder |
| Enrollment |
60 participants |
| Start Date |
2025-01-09 |
| Primary Completion |
2026-04 (estimated) |
| Study Completion |
2026-12 (estimated) |
| Updated on ClinicalTrials.gov |
2026-02-05 |