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New pill aims to stop panic attacks in their tracks

NCT ID NCT05941442

Symptom relief Sponsor: AbbVie 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether darigabat, an oral tablet, could help people with panic disorder. About 80 participants took either darigabat or a placebo for several weeks. The goal was to see if the drug could reduce panic attacks and improve overall symptoms. The study was terminated early, so results are limited.

What this could mean

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

Active substance
darigabat (also known as CVL-865), an oral tablet
What this could lead to
If it works, darigabat could offer a new treatment option to reduce panic attacks and ease panic disorder symptoms.
What could go wrong
This was a small, early-phase trial that was terminated, so results may be incomplete. It is not yet proven to be safe or effective for widespread use.

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

80 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 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.

Inclusion Criteria: * Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by the Standard Mini International Neuropsychiatric Interview (MINI) * Participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the Screening Visit. In the 2 weeks prior to the Baseline Visit, the participant must have had at least 4 panic attacks and no week free of panic attacks * Participants with a PDSS total score ≥12 at the Screening and Baseline Visits * Body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total body weight \>48 kg at Screening Exclusion Criteria: * Participants who have a current significant psychiatric comorbidity * Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (CBT) * Any exposure-based therapy is prohibited throughout the duration of the trial * Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease * Participants who answer "Yes" on the following C-SSRS Suicidal Ideation Items (within the last 6 months) * Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) OR * Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (within the last 2 years) * Any of the Suicidal Behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) OR * Participants who, in the opinion of the investigator, present a serious risk of suicide NOTE: Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

panic disorder

As listed by the trial registrant

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

Panic disorder

Contacts and locations

Locations

  • Atlanta, Georgia

    Atlanta, Georgia, 30331, United States

  • Austin, Texas

    Austin, Texas, 78737, United States

  • Berlin, New Jersey

    Berlin, New Jersey, 08009, United States

  • Boston, Massachusetts

    Boston, Massachusetts, 02131, United States

  • Brooklyn, New York

    Brooklyn, New York, 11229, United States

  • Brooklyn, New York

    Brooklyn, New York, 11235, United States

  • Decatur, Georgia

    Decatur, Georgia, 30030, United States

  • Desoto, Texas

    DeSoto, Texas, 75115, United States

  • Draper, Utah

    Draper, Utah, 84020, United States

  • Elgin, Illinois

    Elgin, Illinois, 60123, United States

  • Everett, Washington

    Everett, Washington, 98201, United States

  • Lafayette, California

    Lafayette, California, 94549, United States

  • Las Vegas, Nevada

    Las Vegas, Nevada, 89102, United States

  • Los Angeles, California

    Los Angeles, California, 90025, United States

  • Miami, Florida

    Miami, Florida, 33175, United States

  • Monroe, North Carolina

    Monroe, North Carolina, 28112, United States

  • New York, New York

    New York, New York, 10016, United States

  • North Miami Beach, Florida

    North Miami Beach, Florida, 33162, United States

  • Oceanside, California

    Oceanside, California, 92056, United States

  • Oklahoma City, Oklahoma

    Oklahoma City, Oklahoma, 73112, United States

  • Orange, California

    Orange, California, 92868, United States

  • Orlando, Florida

    Orlando, Florida, 32807, United States

  • Overland Park, Kansas

    Overland Park, Kansas, 66210, United States

  • Phoenix, Arizona

    Phoenix, Arizona, 85012, United States

  • Riverside, California

    Riverside, California, 92506, United States

  • Rochester, New York

    Rochester, New York, 14618, United States

  • San Jose, California

    San Jose, California, 95124, United States

  • Savannah, Georgia

    Savannah, Georgia, 31405, United States

  • Staten Island, New York

    Staten Island, New York, 10314, United States

  • Torrance, California

    Torrance, California, 90502, United States

  • West Chester, Pennsylvania

    West Chester, Pennsylvania, 19380, United States

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