Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) (PALISADE-3)

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-3)

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-3 and choose to enter the distinct open-label extension phase of the study.

Study Overview

• Status: Active, not recruiting
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Drug: Fasedienol Nasal Spray; Drug: Placebo Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Vistagen Clinical Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Vistagen Clinical Site
    • Little Rock, Arkansas, United States, 72211
      • Vistagen Clinical Site
  • California
    • Lafayette, California, United States, 94549
      • Vistagen Clinical Site
    • Oceanside, California, United States, 92056
      • Vistagen Clinical Site
    • Sherman Oaks, California, United States, 91403
      • Vistagen Clinical Site
  • Colorado
    • Denver, Colorado, United States, 80209
      • Vistagen Clinical Site
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Vistagen Clinical Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Vistagen Clinical Site
    • Lakeland, Florida, United States, 33803
      • Vistagen Clinical Site
    • Orlando, Florida, United States, 32801
      • Vistagen Clinical Site
    • West Palm Beach, Florida, United States, 33407
      • Vistagen Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Vistagen Clinical Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Vistagen Clinical Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Vistagen Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Vistagen Clinical Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Vistagen Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vistagen Clinical Site
  • New York
    • New York, New York, United States, 10128
      • Vistagen Clinical Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Vistagen Clinical Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Vistagen Clinical Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Vistagen Clinical Site
  • Utah
    • Draper, Utah, United States, 84020
      • Vistagen Clinical Site
  • Washington
    • Everett, Washington, United States, 98201
      • Vistagen Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Nasal Spray	Drug: Placebo Nasal Spray; Nasal spray delivered 20 minutes before the PSC
Experimental: Fasedienol Nasal Spray	Drug: Fasedienol Nasal Spray; Nasal spray delivered 20 minutes before the PSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Units of Distress Scale (SUDS)	The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt).	7 days (Visit 2 to Visit 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Impression Scale of Improvement (CGI-I)	The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.	7 days (Visit 2 to Visit 3)
Patient Global Impression of Change (PGI-C)	The PGI-C is a patient self-rated scale to assess improvement. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.	7 days (Visit 2 to Visit 3)

Collaborators and Investigators

• Sponsor: VistaGen Therapeutics, Inc.
• Investigators: Principal Investigator: Michael Liebowitz, MD, Medical Research Network

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: mental health; anxiety; Social Anxiety Disorder; PSC; SAD; social phobia; anxiety treatment; acute treatment; Fasedienol; PH94B; pherine; pherine nasal spray; acute anxiety treatment; anxiotlytic; anxiety nasal spray; public speaking challenge
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Behavior; Personal Satisfaction; Phobia, Social; Anxiety Disorders; Psychological Well-Being
• Other Study ID Numbers: PH94B-CL042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No