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New pill aims to calm social anxiety on the spot

NCT ID NCT07221578

Symptom relief Sponsor: Vanda Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This phase 3 trial tests a single oral dose of VQW-765 versus placebo for quickly reducing acute anxiety in adults with social anxiety disorder. About 500 participants will take the drug as needed before anxiety-provoking situations. The study measures distress levels during and before the event.

What this could mean

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

Active substance
VQW-765 (oral capsule)
What this could lead to
If it works, this could provide a fast-acting, on-demand option to ease acute anxiety during social situations for people with social anxiety disorder.
What could go wrong
This is a late-stage trial, but the drug is still experimental. It may not work better than placebo, and side effects are possible. Success depends on real-world effectiveness and safety.
Why investors are watching

Vanda Pharmaceuticals is running a phase 3 trial of VQW-765, a single-dose pill for acute anxiety in people with social anxiety disorder. For a small company, this late-stage readout is a major event because a positive result could lead to a new approved product, while a negative result would set the program back. The trial compares the drug against a placebo in 500 adults, so the outcome will show whether the drug works and is safe enough to move forward.

If it works: If the trial succeeds, Vanda could have a new treatment for a common condition, which would add to its product lineup. That could bring in future revenue and strengthen the company's position without needing to rely on its existing drugs.

If it fails: Phase 3 trials often fail, and if VQW-765 does not beat placebo or shows safety problems, Vanda would likely abandon the drug. That would waste years of research and money, and the company would have to rely on its other products to sustain itself.

AI-written from the trial record. Speculative, and not investment advice.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Apr 2027

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: 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.

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Conditions

The condition(s) this trial relates to.

social phobia

As listed by the trial registrant

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

Social anxiety disorder (SAD)

Contacts and locations

Locations

  • Vanda Investigational Site

    Phoenix, Arizona, 85012, United States

  • Vanda Investigational Site

    Scottsdale, Arizona, 85260, United States

  • Vanda Investigational Site

    Encino, California, 91316, United States

  • Vanda Investigational Site

    Mission Viejo, California, 92691, United States

  • Vanda Investigational Site

    San Diego, California, 92123, United States

  • Vanda Investigational Site

    San Jose, California, 95124, United States

  • Vanda Investigational Site

    Walnut Creek, California, 94596, United States

  • Vanda Investigational Site

    Denver, Colorado, 80209, United States

  • Vanda Investigational Site

    Jacksonville, Florida, 32256, United States

  • Vanda Investigational Site

    Miami, Florida, 33125, United States

  • Vanda Investigational Site

    Orlando, Florida, 32801, United States

  • Vanda Investigational Site

    Tampa, Florida, 33629, United States

  • Vanda Investigational Site

    Atlanta, Georgia, 30329, United States

  • Vanda Investigational Site

    Suwanee, Georgia, 30024, United States

  • Vanda Investigational Site

    New Orleans, Louisiana, 70115, United States

  • Vanda Investigational Site

    Pikesville, Maryland, 21208, United States

  • Vanda Investigational Site

    Rockville, Maryland, 20852, United States

  • Vanda Investigational Site

    Towson, Maryland, 21204, United States

  • Vanda Investigational Site

    Saint Charles, Missouri, 63304, United States

  • Vanda Investigational Site

    St Louis, Missouri, 63182, United States

  • Vanda Investigational Site

    Las Vegas, Nevada, 89102, United States

  • Vanda Investigational Site

    Princeton, New Jersey, 08540, United States

  • Vanda Investigational Site

    Albuquerque, New Mexico, 87109, United States

  • Vanda Investigational Site

    New York, New York, 10016, United States

  • Vanda Investigational Site

    New York, New York, 10036, United States

  • Vanda Investigational Site

    Charlotte, North Carolina, 28210, United States

  • Vanda Investigational Site

    Wilmington, North Carolina, 28403, United States

  • Vanda Investigational Site

    Houston, Texas, 77081, United States

  • Vanda Investigational Site

    Wichita Falls, Texas, 76309, United States

  • Vanda Investigational Site

    Orem, Utah, 84097, United States

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