A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder

Last updated: October 22, 2025
Sponsor: Engrail Therapeutics INC
Overall Status: Active - Recruiting

Phase

2

Condition

Social Anxiety Disorder (Sad)

Treatment

ENX-102

Placebo

Clinical Study ID

NCT07193563
ENX-102-005
  • Ages 18-70
  • All Genders

Study Summary

This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female at birth, aged 18-70 years, inclusive, at screening Diagnosed withSAD according to the Diagnostic and Statistical Manual of Mental Disorders, FifthEdition, Text Revision (DSM-5-TR), confirmed by a Mini-InternationalNeuropsychiatric Interview (MINI) version 7.0.2

  • LSAS total score of ≥70

  • CGI-S score of ≥4

Exclusion

Key Exclusion Criteria:

  • Clinically predominant psychiatric diagnosis other than SAD per the MINI

  • Any past/lifetime or current diagnosis of a neurocognitive disorder or psychoticdisorder, or any current diagnosis of posttraumatic stress disorder, obsessivecompulsive disorder, or bipolar disorder

  • Reports moderately severe to severe symptoms of depression

  • Frequent use of benzodiazepines within 90 days of screening

  • Used prohibited medication or prohibited herbal or other supplements within 5 half-lives or 21 days prior to Day 1 and unwillingness to refrain from their use for theduration of the trial

  • Recent suicidal ideation or behavior

  • Current or recent moderate or severe substance use disorder as assessed by the MINI

  • Is unwilling/unable to abstain from alcohol, marijuana, THC, CBD, and/or any otherpsychoactive substances (except for nicotine or caffeine) for the duration of thetrial, per Investigator judgment, and/or has a positive alcohol test or drug test atScreening or Day 1

  • Clinically significant abnormal findings in safety assessments

  • Has significant progressive disorders or unstable medical conditions Unable tocomply with the requirements of the study or, in the opinion of the Investigator orSponsor, is unsuitable for the study

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: ENX-102
Phase: 2
Study Start date:
September 05, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • IMA Clinical Research Phoenix

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Active - Recruiting

  • Neuroresearch Group

    Los Angeles 5368361, California 5332921 90025
    United States

    Active - Recruiting

  • Excell Research, Inc.

    Oceanside 5378771, California 5332921 92056
    United States

    Active - Recruiting

  • Anderson Clinical Research

    Redlands 5386754, California 5332921 92374
    United States

    Active - Recruiting

  • California Neuroscience Research, LLC

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Active - Recruiting

  • Sunwise Clincial Research

    Walnut Creek 5406990, California 5332921 94596
    United States

    Active - Recruiting

  • Mountain View Clinical Research

    Denver 5419384, Colorado 5417618 80209
    United States

    Active - Recruiting

  • CNS Health

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc.

    Orlando 4167147, Florida 4155751 32801
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Savannah 4221552, Georgia 4197000 31405
    United States

    Active - Recruiting

  • Redbird Research

    Las Vegas 5506956, Nevada 5509151 89119
    United States

    Active - Recruiting

  • Cenexel HRI

    Berlin 4500771, New Jersey 5101760 08009
    United States

    Active - Recruiting

  • Neurobehavioral Research, Inc.

    Cedarhurst 5111974, New York 5128638 11516
    United States

    Active - Recruiting

  • Clinical Neurosciences, Inc

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

  • Austin Clinical Trials Partners

    Austin 4671654, Texas 4736286 78737
    United States

    Active - Recruiting

  • Grayline Research Center

    Wichita Falls 4741752, Texas 4736286 76309
    United States

    Active - Recruiting

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