Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

Last updated: December 4, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Social Anxiety Disorder (Sad)

Treatment

Placebo

VQW-765

Clinical Study ID

NCT07221578
VP-VQW-765-3201
  • Ages 18-65
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability and willingness to provide written informed consent.

  2. Male and female subjects aged 18-65 years, inclusive.

  3. Current diagnosis of social anxiety disorder.

  4. Liebowitz Social Anxiety Scale total score ≥60.

  5. Public Speaking Anxiety Scale total score ≥60.

  6. Hamilton Depression Rating Scale score ≤18.

Exclusion

Exclusion Criteria:

  1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at riskof suicide in the opinion of the investigator.

  2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusionaldisorders, obsessive-compulsive disorder, or autism spectrum disorder.

  3. Posttraumatic stress disorder or an eating disorder in the past 6 months.

  4. Substance or alcohol use disorder in the past 6 months or positive in drug/alcoholscreening.

  5. Psychotherapy in the past 6 months.

  6. Psychotropic medication in the past 2 months.

  7. Current or planned pregnancy or nursing during the trial period.

  8. Any other reason as determined by the Investigator which may lead to an unfavorablerisk-benefit of study participation, or interference with study objectives.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 22, 2025
Estimated Completion Date:
April 30, 2027

Study Description

The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.

Connect with a study center

  • Vanda Investigational Site

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Encino 5346649, California 5332921 91316
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Newport Beach 5376890, California 5332921 92660
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Diego 5391811, California 5332921 92103
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Jose 5392171, California 5332921 95124
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Walnut Creek 5406990, California 5332921 94596
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Vanda Investigational Site

    Orlando 4167147, Florida 4155751 32801
    United States

    Site Not Available

  • Vanda Investigational Site

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Suwanee 4225309, Georgia 4197000 30024
    United States

    Site Not Available

  • Vanda Investigational Site

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Pikesville 4365387, Maryland 4361885 21208
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Rockville 4367175, Maryland 4361885 20852
    United States

    Active - Recruiting

  • Vanda Investigational Site

    St Louis 4407066, Missouri 4398678 63182
    United States

    Site Not Available

  • Vanda Investigational Site

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Active - Recruiting

  • Vanda Investigational Site

    New York 5128581, New York 5128638 10036
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Charlotte 4460243, North Carolina 4482348 28210
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Wilmington 4499379, North Carolina 4482348 28403
    United States

    Active - Recruiting

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