Recruiting
Phase 2

Fasedienol

Sponsor:

VistaGen Therapeutics, Inc.

Code:

NCT06809179

Conditions

Social Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Fasedienol Nasal Spray - Placebo Nasal Spray

Fasedienol Nasal Spray - Fasedienol Nasal Spray

Placebo Nasal Spray - Placebo Nasal Spray

Study Details

Brief 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

Social Anxiety Disorder

Study ID

NCT06809179

Start date

Jan 9, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fasedienol Nasal Spray (single dose)

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses.

experimental: Fasedienol Nasal Spray (repeat dose)

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses.

experimental: Placebo Nasal Spray

Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses.

Interventions

Fasedienol Nasal Spray - Placebo Nasal Spray

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses.

Fasedienol Nasal Spray - Fasedienol Nasal Spray

Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses.

Placebo Nasal Spray - Placebo Nasal Spray

Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses.

Primary outcome measure

  • Subjective Units of Distress Scale (SUDS) [ Time Frame: 7 days (Visit 2 to Visit 3) ]

Central Contacts and Locations

Central contacts

Clinical Studies Vistagen Therapeutics, Inc.

650-577-3693clinicalstudies@vistagen.com

Locations

Vistagen Clinical Site

Recruiting

Sherman Oaks, California, United States, 91403

Vistagen Clinical Site

Recruiting

Walnut Creek, California, United States, 94596

Vistagen Clinical Site

Recruiting

Largo, Florida, United States, 33777

Vistagen Clinical Site

Recruiting

Saint Charles, Missouri, United States, 63304

Vistagen Clinical Site

Recruiting

Toms River, New Jersey, United States, 08755

Vistagen Clinical Site

Recruiting

Cary, North Carolina, United States, 27511

Vistagen Clinical Site

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

More Information

Sponsor

VistaGen Therapeutics, Inc.

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Fasedienol
  • PH94B
  • social anxiety disorder
  • social anxiety
  • SAD
  • pherine
  • pherine nasal spray
  • acute treatment
  • anxiolytic
  • mental health
  • performance anxiety
  • anxiety nasal spray
  • anxiety treatment
  • public speaking anxiety
  • social phobia
  • phobic disorders
  • mental disorder
  • speech task

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VistaGen Therapeutics, Inc. on 2026-02-05.