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New pill aims to lift bipolar depression in just 6 weeks

NCT ID NCT07172516

Symptom relief Sponsor: Xenon Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether a daily pill called azetukalner can safely reduce depression in people with bipolar I or II disorder. About 400 adults currently in a depressive episode will take either the drug or a placebo for 6 weeks. Researchers will measure mood changes using standard depression scales.

What this could mean

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

Active substance
azetukalner (also called XEN1101), a daily pill
What this could lead to
If it works, this could provide a new treatment option for bipolar depression, easing depressive episodes with a once-daily pill.
What could go wrong
This is an early Phase 3 trial, so results are not guaranteed. The drug may not outperform placebo, and side effects are still being studied.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

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 74 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: * Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age. * Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2. * Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI). * Current MDE must has a duration of ≥4 weeks and ≤12 months. Key Exclusion Criteria: * Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression. * Participant has any nonbipolar psychiatric diagnosis. * Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit. * Participant has a symptomatic eating disorder within the 12 months prior to screening visit. * Participant has a Young Mania Rating Scale (YMRS) score \>12 points at screening visit or randomization. * Participant has been hospitalized for mania within the 30 days prior to screening visit. * Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks). * Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months. * Participant has self-injurious behavior without intent to die in the 12 months prior to screening. * Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization. * Participants with medical conditions that may interfere with the purpose or conduct of the study. * Participant is pregnant, breastfeeding, or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder bipolar I disorder bipolar II disorder

As listed by the trial registrant

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

Bipolar depression Bipolar disorder Bipolar I disorder Bipolar ii disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Advanced Quality Medical Research

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • CenExel iResearch

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Central Miami Medical Institute

    RECRUITING

    Miami, Florida, 33125, United States

  • Clinical Innovations Inc

    RECRUITING

    Bellflower, California, 90706, United States

  • Clinical Innovations Inc

    RECRUITING

    Riverside, California, 92506, United States

  • Clinical Neuroscience Solutions, LLC

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, LLC

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, LLC

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Core Clinical Research

    RECRUITING

    Everett, Washington, 98201, United States

  • DelRicht Research

    TERMINATED

    Charlotte, North Carolina, 28210, United States

  • Denali Health Atlanta, LLC

    RECRUITING

    Stone Mountain, Georgia, 30083, United States

  • Diagnostic and Consulting Center XI Sofia

    RECRUITING

    Sofia, 1309, Bulgaria

  • Diagnostics-Consultative Center Mladost M Varna OOD

    RECRUITING

    Varna, 09020, Bulgaria

  • Elevate Synapsis, LLC

    RECRUITING

    Atascocita, Texas, 77346, United States

  • Grayline Research Center

    RECRUITING

    Wichita Falls, Texas, 76309, United States

  • HU. Álvaro Cunqueiro

    RECRUITING

    Pontevedra, 36312, Spain

  • Hospital Universitari Son Espases

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Instituto de Psiquiatría y Salud Mental. Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, 28007, Spain

  • Integrative Clinical Trials LLC

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Lehigh Center for Clinical Research

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Lumina Clinical Research Center

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Memorial Hermann Village

    RECRUITING

    Houston, Texas, 77043, United States

  • Multiprofile Hospital for Active Treatment "Dr. Hristo Stambolski"

    RECRUITING

    Kazanlak, 6100, Bulgaria

  • NRC Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • Neurobehavioral Research Inc

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • Noble Clinical Research

    RECRUITING

    Tucson, Arizona, 85704, United States

  • PharmaSouth Research, LLC

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • ProScience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Psychiatric Care and Research Center

    RECRUITING

    O'Fallon, Missouri, 63368, United States

  • Redbird Clinical Research, LLC

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Revival Research Institute

    RECRUITING

    Elgin, Illinois, 60123, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • Saint Naum Medical Center

    RECRUITING

    Sofia, 1113, Bulgaria

  • Sarkis Clinical Research

    RECRUITING

    Gainesville, Florida, 32607, United States

  • State Psychiatric Hospital Lovech

    RECRUITING

    Lovech, 05500, Bulgaria

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Synexus Clinical Research, Inc.

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • University Hospital Münster

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Carl Gustav Carus, TU Dresden - Klinik und Poliklinik für Psychiatrie

    RECRUITING

    Dresden, 01307, Germany

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States

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