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New anxiety drug shows promise in early trial

NCT ID NCT05749055

Symptom relief Sponsor: Engrail Therapeutics INC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study tested a new drug called ENX-102 in 252 adults with generalized anxiety disorder. Participants received either the drug or a placebo for several weeks. Researchers measured changes in anxiety symptoms using a standard rating scale. The goal was to see if ENX-102 reduces anxiety better than a placebo and to check its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ENX-102 (a drug that targets GABA receptors in the brain to reduce anxiety)
What this could lead to
If successful, ENX-102 could offer a new treatment option for people with generalized anxiety disorder, potentially with fewer side effects than current medications.
What could go wrong
This is a Phase 2 trial with only 252 participants, so results may not hold up in larger studies. The drug may not work better than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

252 people

The number who actually took part.

Started

Jul 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening * Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2 * Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1 Key Exclusion Criteria: * Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI * Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication * Reports moderately severe to severe symptoms of depression * Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial * Recent suicidal ideation or behavior * Current or recent moderate to severe substance use disorder as assessed by the MINI * Clinically significant abnormal findings in safety assessments * 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

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized anxiety disorder

Contacts and locations

Locations

  • Accel Research Sites Network - Lakeland CRU

    Lakeland, Florida, 33803, United States

  • Accel Research Sites Network - Maitland CRU

    Maitland, Florida, 32751, United States

  • Aim Trials

    Plano, Texas, 75093, United States

  • Alliance Research

    Long Beach, California, 90712, United States

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Anderson Clinical Research

    Redlands, California, 92374, United States

  • Austin Clinical Trials Partners

    Austin, Texas, 78737, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • California Neuroscience Research, LLC

    Sherman Oaks, California, 91403, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119, United States

  • Collaborative Neuroscience Research, LLC (CNS)

    Garden Grove, California, 92845, United States

  • Collective Medical Research

    Overland Park, Kansas, 66210, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Excell Research, Inc.

    Oceanside, California, 92056, United States

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • IMA Clinical Research

    Las Vegas, Nevada, 89102, United States

  • IMA Clinical Research Phoenix

    Phoenix, Arizona, 85012, United States

  • Mountain View Clinical Research

    Denver, Colorado, 80209, United States

  • NRC Research Institute

    Los Angeles, California, 90015, United States

  • Neurobehavioral Research

    Cedarhurst, New York, 11516, United States

  • Pacific Clinical Research Management Group

    Upland, California, 91786, United States

  • Precise Research Centres

    Flowood, Mississippi, 39232, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235, United States

  • Sun Valley Research Center

    Imperial, California, 92251, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Vertex Clinical Research

    Clermont, Florida, 34711, United States

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