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One shot to ease anxiety? new drug RE104 enters human trial

NCT ID NCT07489651

Symptom relief Sponsor: Reunion Neuroscience 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether a single injection of RE104 can reduce anxiety symptoms in 64 adults with generalized anxiety disorder, compared to a placebo. Participants receive one dose and are followed for four weeks to measure changes in anxiety severity using a standard rating scale. The study is currently recruiting.

What this could mean

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

Active substance
RE104 for injection
What this could lead to
If it works, this could point toward a fast-acting, single-dose treatment option for generalized anxiety disorder.
What could go wrong
This is an early Phase 2 trial with only 64 people, so results may not apply broadly. The drug may not reduce anxiety better 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 64 people

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

Started

Apr 2026

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 74 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: * Has Generalized Anxiety Disorder as defined by DSM-5-TR * If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant. * Is willing and able to comply with the conditions and requirements of the study Exclusion Criteria: * Has a significant risk of suicide * Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder * Has other concurrent psychiatric disorders that is the primary disorder. * Has other medically significant conditions rendering unsuitability for the study * Has used or will need to use prohibited medications or therapies * Has a known sensitivity or intolerance to study intervention or potential rescue medications

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder

As listed by the trial registrant

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

Generalized anxiety disorder

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aim Trials, LLC

    RECRUITING

    Plano, Texas, 75093, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Austin Clinical Trial Partners

    RECRUITING

    Austin, Texas, 78737, United States

    Contact Email: •••••@•••••

  • BioBehavioral Research Austion

    RECRUITING

    Austin, Texas, 78759, United States

  • Cedar Clinical Research

    RECRUITING

    Draper, Utah, 84020, United States

  • CenExel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Garden Grove, California, 92845, United States

  • Evergreen Clinical Trials

    RECRUITING

    Norcross, Georgia, 30092, United States

  • Henry Ford Medical Center - Columbus

    RECRUITING

    Novi, Michigan, 48377, United States

  • Inner Space State Street

    RECRUITING

    Orem, Utah, 84058, United States

  • Innovative Clinical Research, Inc.

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • Kadima Neuropsychiatry Institute

    RECRUITING

    La Jolla, California, 92037, United States

  • Lighthouse Psychiatry

    RECRUITING

    Gilbert, Arizona, 85234, United States

    Contact Email: •••••@•••••

  • Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • NYU-H+C Clinical and Translational Science Institute

    RECRUITING

    New York, New York, 10016, United States

  • Neuro-Behavioral Clinical Research, Inc.

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Open Mind Therapeutics

    RECRUITING

    San Francisco, California, 94114, United States

  • Preferred Research Partners, Inc.

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Suburban Research Associates

    RECRUITING

    West Chester, Pennsylvania, 19380, United States

  • Summit Headlands LLC

    RECRUITING

    Portland, Oregon, 97210, United States

  • TRIP Clinic at Psychedelic Science Institute

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact Email: •••••@•••••

  • UNM Research Program Psychedelic Therapies

    RECRUITING

    Albuquerque, New Mexico, 14624, United States

  • University of Alabama (UAB) Clinical Research Unit (CRU)

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • Uptown Research Institute

    RECRUITING

    Chicago, Illinois, 60640, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.