New drug shows promise for Long-Term bipolar depression control

NCT ID NCT07217860

ENROLLING_BY_INVITATION Disease control Sponsor: Xenon Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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

Contacts and locations

Locations

CenExel iResearch

Decatur, Georgia, 30030, United States
Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions Memphis

Memphis, Tennessee, 38119, United States
Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, 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

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