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CompletedPhase 2

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

Key facts

Who runs it
Engrail Therapeutics INC
Where
Austin, Berlin, Brooklyn, Cedarhurst, Denver, Everett, Jacksonville, La Jolla, Las Vegas, Los Angeles, Memphis, Oceanside, Orlando, Phoenix, Redlands, Savannah, Sherman Oaks, Walnut Creek, and Wichita Falls, United StatesSee the 20 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
47 people enrolled
Started
5 Sept 2025
Ended
19 Mar 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ENX-102
  • Placebo
Record updated
8 April 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Male or female at birth, aged 18-70 years, inclusive, at screening Diagnosed with SAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
  • LSAS total score of ≥70
  • CGI-S score of ≥4

Who cannot take part

  • 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 the duration of the trial
  • Is unwilling/unable to abstain from alcohol, marijuana, THC, CBD, and/or any other psychoactive substances (except for nicotine or caffeine) for the duration of the trial, per Investigator judgment, and/or has a positive alcohol test or drug test at Screening or Day 1
  • Clinically predominant psychiatric diagnosis other than SAD per the MINI
  • Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
  • Current or recent moderate or severe substance use disorder as assessed by the MINI
  • Has significant progressive disorders or unstable medical conditions Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
  • Reports moderately severe to severe symptoms of depression
  • Frequent use of benzodiazepines within 90 days of screening
  • Recent suicidal ideation or behavior
  • Clinically significant abnormal findings in safety assessments

Where in United States

  • Austin Clinical Trials PartnersAustin, United States
  • Cenexel HRIBerlin, United States
  • SPRI Clinical Trials, LLCBrooklyn, United States
  • Neurobehavioral Research, Inc.Cedarhurst, United States
  • Mountain View Clinical ResearchDenver, United States
  • Core Clinical ResearchEverett, United States
  • CNS HealthJacksonville, United States
  • University of CaliforniaLa Jolla, United States
  • IMA Clinical ResearchLas Vegas, United States
  • Redbird ResearchLas Vegas, United States
  • Neuroresearch GroupLos Angeles, United States
  • Clinical Neurosciences, IncMemphis, United States
  • Excell Research, Inc.Oceanside, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • IMA Clinical Research PhoenixPhoenix, United States
  • Anderson Clinical ResearchRedlands, United States
  • CenExel iResearch, LLCSavannah, United States
  • California Neuroscience Research, LLCSherman Oaks, United States
  • Sunwise Clincial ResearchWalnut Creek, United States
  • Grayline Research CenterWichita Falls, United States

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • ENX-102Treatment being tested

    Participants will receive 2 mg of ENX-102 in capsule form orally once daily for 6 weeks, followed by 2 weeks of tapered dose and up to 2 weeks of placebo in capsule form before and/or after the 8-week ENX-102 treatment period.

  • PlaceboPlacebo, for comparison

    Participants will receive ENX-102 matching placebo in capsule once daily for 10 weeks

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The ENCalmSocial Trial: A Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder
Record updated
8 April 2026