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Fasedienol Nasal Spray for treating anxiety in adults with social anxiety disorder

US, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder, With an Open-Label Extension (PALISADE-4)

Phase 3 Interventional VistaGen Therapeutics, Inc. · NCT06615557

This study tests if a nasal spray called Fasedienol can help adults with social anxiety feel less anxious, especially when facing public speaking situations.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment236 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVistaGen Therapeutics, Inc. Industry-sponsored
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT06615557 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy, safety, and tolerability of Fasedienol Nasal Spray for the acute treatment of anxiety in adults aged 18 to 65 with Social Anxiety Disorder, particularly in response to public speaking challenges. Participants will receive either the Fasedienol spray or a placebo, with the option to enter an open-label extension phase for further assessment. The study aims to determine how well this treatment alleviates acute anxiety symptoms and its safety profile over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of Social Anxiety Disorder and significant anxiety symptoms as measured by the Liebowitz Social Anxiety Score.

Not a fit: Patients with a history of severe psychiatric disorders or those with certain exclusion criteria, such as bipolar disorder or schizophrenia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective option for managing acute anxiety symptoms in individuals with social anxiety disorder.

How similar studies have performed: Previous studies have shown promise with similar approaches in treating anxiety disorders, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Written informed consent provided prior to conducting any study-specific assessment.
* Male and female adults, 18 through 65 years of age, inclusive.
* Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
* Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1).
* Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16.
* Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study
* Subjects must have normal olfactory function

Exclusion Criteria:

* Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder.
* Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis.
* Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry.
* In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others.
* Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
* Two or more documented failed adequate treatment trials with a registered medication approved for SAD.
* Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy.
* Subjects taking psychotropic medications within 30 days before Visit 2.
* Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2.
* Prior participation in a clinical trial involving fasedienol.
* Participation in any other clinical trial within the last 30 days or during the course of the current trial.
* Subjects with a positive urine drug screen.
* Women who have a positive urine pregnancy test.
* Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study.
* Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1).
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Where this trial is running

Phoenix, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Social Anxiety DisorderFasedienolPH94Bsocial anxiety disordersocial anxietySADpherinepherine nasal spray
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.