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New drug shows promise for Long-Term bipolar depression control

NCT ID NCT07217860

Disease control 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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This Phase 3 study tests the long-term safety and effectiveness of azetukalner, a daily pill, in 400 adults with bipolar I or II depression who previously completed a related study. Participants take the drug for 52 weeks, and researchers track side effects, mood changes, and quality of life. The goal is to see if azetukalner can be a safe, long-term treatment option.

What this could mean

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

Active substance
azetukalner
What this could lead to
If successful, this could provide a new long-term treatment option for managing bipolar depression.
What could go wrong
This is an open-label study with no placebo group, so results may be less reliable. Side effects are still being evaluated, and it only includes people who already tolerated the drug in a prior study.

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

Oct 2025

Expected to finish

Aug 2029

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 75 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: * Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression. * Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them. * Participant is willing to comply with the contraception requirements. Exclusion Criteria: * Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study. * Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study. * Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol. * Participant is pregnant, breastfeeding, or planning to become pregnant. * Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study. * Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.

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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

    20 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Advanced Quality Medical Research

    Orland Park, Illinois, 60462, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • CenExel iResearch

    Decatur, Georgia, 30030, United States

  • Central Miami Medical Institute

    Miami, Florida, 33125, United States

  • Clinical Innovations, Inc

    Riverside, California, 92506, United States

  • Clinical Innovations, Inc, dba CITrials

    Bellflower, California, 90706, United States

  • Clinical Neuroscience Solutions, LLC

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, LLC

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, LLC

    Memphis, Tennessee, 38119, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Denali Health Atlanta, LLC

    Stone Mountain, Georgia, 30083, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103, United States

  • Lumina Clinical Research Center

    Cherry Hill, New Jersey, 92866, United States

  • Neurobehavioral Research Inc

    Cedarhurst, New York, 11516, United States

  • PharmaSouth Research, LLC

    Coral Gables, Florida, 33146, United States

  • ProScience Research Group

    Culver City, California, 90230, United States

  • Synexus Clinical Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Woodland International Research Group

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

More trials for these conditions

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