New pill aims to lift bipolar depression in just 6 weeks

NCT ID NCT07172516

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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

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
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, Inc
RECRUITING

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc
RECRUITING

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

Jacksonville, Florida, 32256, United States
Core Clinical Research
RECRUITING

Everett, Washington, 98201, United States
DelRicht Research
RECRUITING

Charlotte, North Carolina, 28210, United States
Denali Health Atlanta, LLC
RECRUITING

Stone Mountain, Georgia, 30083, United States
Elevate Synapsis, LLC
RECRUITING

Atascocita, Texas, 77346, United States
Grayline Research Center
RECRUITING

Wichita Falls, Texas, 76309, United States
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
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
Synexus Clinical Research, Inc.
RECRUITING

Atlanta, Georgia, 30328, United States
Woodland International Research Group
RECRUITING

Little Rock, Arkansas, 72211, United States
Woodland Research Northwest
RECRUITING

Rogers, Arkansas, 72758, United States

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