Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT06809179 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Fasedienol Nasal Spray - Placebo Nasal Spray
- DRUG Fasedienol Nasal Spray - Fasedienol Nasal Spray
- DRUG Placebo Nasal Spray - Placebo Nasal Spray
Study Locations (9)
California
- Vistagen Clinical Site — Sherman Oaks
- Vistagen Clinical Site — Walnut Creek
Florida
- Vistagen Clinical Site — Largo
Missouri
- Vistagen Clinical Site — Saint Charles
New Jersey
- Vistagen Clinical Site — Toms River
North Carolina
- Vistagen Clinical Site — Cary
Ohio
- Vistagen Clinical Site — Cleveland
Pennsylvania
- Vistagen Clinical Site — Plymouth Meeting
Texas
- Vistagen Clinical Site — Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-01-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06809179
The ClinicalTrials.gov registry entry for NCT06809179 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VistaGen Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Social Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions — of which Fasedienol Nasal Spray - Placebo Nasal Spray is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06809179 reports 9 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06809179 about?
NCT06809179 is a clinical study titled "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 w...
What is the current status of trial NCT06809179?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-01-09. Estimated completion is 2026-12.
What conditions does trial NCT06809179 study?
This clinical trial studies the following conditions: Social Anxiety Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06809179?
The interventions under investigation include: Fasedienol Nasal Spray - Placebo Nasal Spray (DRUG), Fasedienol Nasal Spray - Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray - Placebo Nasal Spray (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06809179?
This trial is sponsored by VistaGen Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06809179 being conducted?
This trial has 9 study locations across California, Florida, Missouri, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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