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Could a brain chemical blocker ease social anxiety? new trial launches

NCT ID NCT07323784

Symptom relief Sponsor: Newleos Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether a new drug called NTX-1472 can safely reduce symptoms of social anxiety disorder. About 100 adults will take either the drug or a placebo daily for 8 weeks. Researchers will measure changes in anxiety and avoidance using a standard scale, and track any side effects.

What this could mean

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

Active substance
NTX-1472 (a V1a receptor antagonist)
What this could lead to
If it works, this could point toward a new treatment option for social anxiety disorder that works differently from current medications.
What could go wrong
This is an early Phase 2 trial with only 100 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Dec 2025

Expected to finish

Jan 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.

Key Inclusion Criteria * Has provided written informed consent for the study and is willing to comply with all requirements of the protocol * English speaker * Male or female, ≥18 and ≤65 years of age * Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT). * Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening * Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score \<16 at Screening * If participant is of childbearing potential, must commit to practicing effective methods of birth control during the study and at least 14 days after the last dose. Key Exclusion Criteria * Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT. * Current diagnosis of any of the following psychiatric condition(s) as defined by the DSM-5 (participants with current generalized anxiety disorder may be included): Attention-deficit/hyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder. * Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder (in adulthood), Obsessive-compulsive disorder, Schizophrenia spectrum or other psychotic disorder, Substance use disorder (within 12 months of Screening). * Receiving daily psychotropics within 4 weeks of Screening * Is at risk for suicidal ideation as per C-SSRS * Has moderate or severe hepatic impairment * Has severe renal impairment * Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SOAR Clinical Study Site

    RECRUITING

    Encino, California, 91316, United States

  • SOAR Clinical Study Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • SOAR Clinical Study Site

    RECRUITING

    Oceanside, California, 92056, United States

  • SOAR Clinical Study Site

    RECRUITING

    San Jose, California, 95124, United States

  • SOAR Clinical Study Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • SOAR Clinical Study Site

    RECRUITING

    Tampa, Florida, 33615, United States

  • SOAR Clinical Study Site

    RECRUITING

    Boston, Massachusetts, 02131, United States

  • SOAR Clinical Study Site

    ACTIVE_NOT_RECRUITING

    Las Vegas, Nevada, 89119, United States

  • SOAR Clinical Study Site

    RECRUITING

    Brooklyn, New York, 11229, United States

  • SOAR Clinical Study Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • SOAR Clinical Study Site

    RECRUITING

    Austin, Texas, 78737, United States

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