RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

NCT07489651 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RE104-203-GAD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Keywords

GAD

Outcome Measures

Primary Outcomes (1)

• RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score

  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 Outcomes (5)

• RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)

  Weeks 1, 2, 8 and 12

• RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)

  Weeks 1, 2, 4, 8 and 12

• RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7)

  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

  Weeks 1, 2, 4, 8 and 12

• RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

  From dosing through study completion (post-dose follow-up is for 12 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A single subcutaneous injection of 0.9% sodium chloride for injection

Drug: Placebo

30 mg RE104

EXPERIMENTAL

A single subcutaneous injection of 30 mg RE104 for Injection

Drug: RE104 for Injection

Interventions

RE104 for Injection DRUG

Single, subcutaneous dose of RE104 for Injection

30 mg RE104

Placebo DRUG

Single, subcutaneous dose of 0.9% sodium chloride for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reunion Neuroscience Inc: lead

Study Sites (12)

Lighthouse Psychiatry

Gilbert, Arizona, 85234, United States

RECRUITING

Open Mind Therapeutics

San Francisco, California, 94114, United States

RECRUITING

TRIP Clinic at Psychedelic Science Institute

Santa Monica, California, 90404, United States

RECRUITING

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

UNM Research Program Psychedelic Therapies

Albuquerque, New Mexico, 14624, United States

RECRUITING

Summit Headlands LLC

Portland, Oregon, 97210, United States

RECRUITING

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

RECRUITING

Aim Trials, LLC

Plano, Texas, 75093, United States

RECRUITING

Cedar Clinical Research

Draper, Utah, 84020, United States

RECRUITING

Inner Space State Street

Orem, Utah, 84058, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Injections

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Pollack, M.D.

  Reunion Neuroscience Inc

  STUDY DIRECTOR

Central Study Contacts

Mark Pollack Chief Medical Officer, M.D.

CONTACT

1-888-880-REUN; info@reunionneuro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)