Home › Generalized Anxiety Disorder › NCT07489651

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

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

Who can join

Ages 18 to 74 · All sexes

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

About the study

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

What is being tested

• RE104 for Injection (drug)
• Placebo (drug)

Sponsor: Reunion Neuroscience Inc · Participants: 160 · Started: Apr 20, 2026

Contact the study team

• Mark Pollack Chief Medical Officer, M.D. · Phone: 1-888-880-REUN

Official record on ClinicalTrials.gov — NCT07489651

Locations in the U.S.

Conditions

• Generalized Anxiety Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.