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New nasal spray could tame stage fright in social anxiety

NCT ID NCT06358651

Symptom relief Sponsor: VistaGen Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a nasal spray called fasedienol can quickly reduce anxiety during a public speaking challenge in adults with social anxiety disorder. About 238 participants will receive either the spray or a placebo before speaking. The study also looks at long-term safety for up to 12 months of use as needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fasedienol nasal spray
What this could lead to
If successful, this could offer a fast-acting, on-demand treatment for anxiety triggered by public speaking in people with social anxiety disorder.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The effect may be modest, and the spray is only for acute episodes, not a long-term solution. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

238 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (DSM-5), and confirmed by the Mini-International Neuropsychiatric Interview (MINI). * Clinician-rated Liebowitz Social Anxiety Scale (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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder Psychological Well-Being social phobia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Social anxiety disorder

Contacts and locations

Locations

  • Vistagen Clinical Site

    Phoenix, Arizona, 85012, United States

  • Vistagen Clinical Site

    Fayetteville, Arkansas, 72703, United States

  • Vistagen Clinical Site

    Little Rock, Arkansas, 72211, United States

  • Vistagen Clinical Site

    Lafayette, California, 94549, United States

  • Vistagen Clinical Site

    Oceanside, California, 92056, United States

  • Vistagen Clinical Site

    Sherman Oaks, California, 91403, United States

  • Vistagen Clinical Site

    Denver, Colorado, 80209, United States

  • Vistagen Clinical Site

    Cromwell, Connecticut, 06416, United States

  • Vistagen Clinical Site

    Jacksonville, Florida, 32256, United States

  • Vistagen Clinical Site

    Lakeland, Florida, 33803, United States

  • Vistagen Clinical Site

    Orlando, Florida, 32801, United States

  • Vistagen Clinical Site

    West Palm Beach, Florida, 33407, United States

  • Vistagen Clinical Site

    Chicago, Illinois, 60612, United States

  • Vistagen Clinical Site

    Overland Park, Kansas, 66210, United States

  • Vistagen Clinical Site

    Baltimore, Maryland, 21208, United States

  • Vistagen Clinical Site

    Boston, Massachusetts, 02131, United States

  • Vistagen Clinical Site

    Saint Charles, Missouri, 63304, United States

  • Vistagen Clinical Site

    Las Vegas, Nevada, 89119, United States

  • Vistagen Clinical Site

    New York, New York, 10128, United States

  • Vistagen Clinical Site

    Media, Pennsylvania, 19063, United States

  • Vistagen Clinical Site

    Memphis, Tennessee, 38119, United States

  • Vistagen Clinical Site

    Fort Worth, Texas, 76104, United States

  • Vistagen Clinical Site

    Draper, Utah, 84020, United States

  • Vistagen Clinical Site

    Everett, Washington, 98201, United States

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