New drug shows promise for Long-Term bipolar depression control
NCT ID NCT07217860
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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CenExel iResearch
Decatur, Georgia, 30030, United States
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Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
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Clinical Neuroscience Solutions Memphis
Memphis, Tennessee, 38119, United States
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Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
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Core Clinical Research
Everett, Washington, 98201, United States
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Denali Health Atlanta, LLC
Stone Mountain, Georgia, 30083, United States
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Grayline Research Center
Wichita Falls, Texas, 76309, United States
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Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18103, United States
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Lumina Clinical Research Center
Cherry Hill, New Jersey, 92866, United States
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Neurobehavioral Research Inc
Cedarhurst, New York, 11516, United States
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PharmaSouth Research, LLC
Coral Gables, Florida, 33146, United States
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ProScience Research Group
Culver City, California, 90230, United States
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Synexus Clinical Research, Inc.
Atlanta, Georgia, 30328, United States
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Woodland International Research Group
Little Rock, Arkansas, 72211, United States
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Woodland Research Northwest
Rogers, Arkansas, 72758, United States