Clinical trials

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Condition / disease
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Status: Recruiting

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

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.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: VistaGen Therapeutics, Inc.Updated: Feb 5, 2026Locations: 9
Eligibility criteria

Written informed consent provided prior to conducting any study-specific assessm... [+6]

Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disord... [+15]