RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

May 13, 2026 updated by: Reunion Neuroscience Inc

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mark Pollack Chief Medical Officer, M.D.
  • Phone Number: 1-888-880-REUN
  • Email: info@reunionneuro.com

Study Locations

  • United States
    • Arizona
    • California
      • San Francisco, California, United States, 94114
      • Santa Monica, California, United States, 90404
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University Of South Florida
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Contact:
      • Decatur, Georgia, United States, 30030
    • New Mexico
      • Albuquerque, New Mexico, United States, 14624
        • Recruiting
        • UNM Research Program Psychedelic Therapies
        • Contact:
    • Oregon
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • Austin Clinical Trial Partners
        • Contact:
      • Plano, Texas, United States, 75093
    • Utah
      • Draper, Utah, United States, 84020
      • Orem, Utah, United States, 84058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Placebo Comparator: Placebo
A single subcutaneous injection of 0.9% sodium chloride for injection
Drug: Placebo
Single, subcutaneous dose of 0.9% sodium chloride for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
Time Frame: Week 4
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Weeks 1, 2, 8 and 12
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Weeks 1, 2, 8 and 12
RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)
Time Frame: Weeks 1, 2, 4, 8 and 12
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Weeks 1, 2, 4, 8 and 12
RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7)
Time Frame: Day 1 and Weeks 1, 2, 4, 8 and 12
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Day 1 and Weeks 1, 2, 4, 8 and 12
RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore
Time Frame: Weeks 1, 2, 4, 8 and 12
The Hospital Anxiety and Depression Scale (HADS) is a self-reported scale measure the severity of depression and anxiety in patients with comorbid medical conditions. The scale consists of 14 items (7 for anxiety and 7 for depression), with a score ranging between 0 and 21 for the anxiety and depression subscales.
Weeks 1, 2, 4, 8 and 12
RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
Time Frame: From dosing through study completion (post-dose follow-up is for 12 weeks)
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
From dosing through study completion (post-dose follow-up is for 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reunion Neuroscience Inc

Investigators

  • Study Director: Mark Pollack, M.D., Reunion Neuroscience Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE104-203-GAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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