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VQW-765 for on-demand relief of social anxiety during public speaking

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder

Phase 3 Interventional Vanda Pharmaceuticals · NCT07221578

This trial will see if a single oral dose of VQW-765 helps adults with social anxiety disorder reduce anxiety during a public-speaking stress test compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVanda Pharmaceuticals Industry-sponsored
Locations29 sites (Phoenix, Arizona and 28 other locations)
Trial IDNCT07221578 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial enrolling about 500 adults with diagnosed social anxiety disorder. Participants are randomized 1:1 to receive a single oral dose of VQW-765 or placebo, followed shortly by a standardized psychosocial stress (public-speaking) test to measure acute symptoms. Safety is monitored and a remote safety follow-up visit occurs 1–2 weeks after the treatment visit. The trial excludes people with recent substance use disorders, certain psychiatric comorbidities, recent psychotherapy or psychotropic medication, and pregnant or nursing individuals.

Who should consider this trial

Good fit: Adults aged 18–65 with a current diagnosis of social anxiety disorder who meet threshold symptom scores (Liebowitz Social Anxiety Scale ≥60 and Public Speaking Anxiety Scale ≥60), have mild or no depression (HAM-D ≤18), and can attend an in-person treatment visit are ideal candidates.

Not a fit: People with recent substance or alcohol use disorder, recent psychotherapy or psychotropic medication, contraindicated psychiatric diagnoses (e.g., bipolar disorder, schizophrenia, PTSD within 6 months), active suicidality, or who are pregnant or nursing are unlikely to be eligible or benefit from this on-demand approach.

Why it matters

Potential benefit: If successful, VQW-765 could provide a fast-acting, on-demand oral option to reduce anxiety for people facing social stressors like public speaking.

How similar studies have performed: Short-term, on-demand pharmacologic approaches (for example, beta-blockers for performance anxiety) have shown symptom relief in some settings, but VQW-765 is a novel investigational product and this Phase 3 trial is among the first large randomized tests of its efficacy.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 Criteria:

1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, 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/alcohol screening.
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 unfavorable risk-benefit of study participation, or interference with study objectives.

Where this trial is running

Phoenix, Arizona and 28 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 DisorderSocial PhobiaSADPublic Speaking AnxietyPerformance Anxiety
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.