Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
NCT06615557 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Fasedienol Nasal Spray
- DRUG Placebo Nasal Spray
Study Locations (20)
California
- Vistagen Clinical Site — Bellflower
- Vistagen Clinical Site — Oceanside
- Vistagen Clinical Site — Orange
- Vistagen Clinical Site — Redlands
- Vistagen Clinical Site — Torrance
Illinois
- Vistagen Clinical Site — Chicago
- Vistagen Clinical Site — Naperville
Nevada
- Vistagen Clinical Site — Las Vegas
- Vistagen Clinical Site — Las Vegas
Arizona
- Vistagen Clinical Site — Phoenix
Arkansas
- Vistagen Clinical Site — Little Rock
Colorado
- Vistagen Clinical Site — Denver
Florida
- Vistagen Clinical Site — Tampa
Georgia
- Vistagen Clinical Site — Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2024-09-16 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06615557
The ClinicalTrials.gov registry entry for NCT06615557 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 236 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 (SAD) appearing as the primary indexed condition, and to 2 interventions — of which Fasedienol 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: NCT06615557 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Illinois, Nevada. 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 NCT06615557 about?
NCT06615557 is a clinical study titled "Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)". 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...
What is the current status of trial NCT06615557?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2024-09-16. Estimated completion is 2027-04.
What conditions does trial NCT06615557 study?
This clinical trial studies the following conditions: Social Anxiety Disorder (SAD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06615557?
The interventions under investigation include: Fasedienol Nasal Spray (DRUG), Placebo Nasal Spray (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06615557?
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 NCT06615557 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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