AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

This study is investigating a new medication, Azetukalner, for individuals experiencing depression as part of Bipolar I or Bipolar II disorder. The main goal is to understand how safe this new medicine is, how well people can take it, and if it helps to improve symptoms of depression over a long period. We will be carefully monitoring any side effects and seeing if the medicine makes a positive difference in participants' daily lives and overall mood. This is a large-scale study, often called a 'Phase III' trial, which means it's one of the final steps before a medicine might become widely available.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Xenon Pharmaceuticals Inc.

Enrolment target

Start

28 Apr 2026

Depressive episodes associated with Bipolar disorder I or II (Bipolar Depression)

What is this study about?

Imagine feeling very low, sad, and struggling with everyday tasks – that's what depression can feel like. For some people, these feelings are part of a condition called Bipolar Disorder. This condition involves shifts in mood, including periods of high energy (mania) and periods of low energy and sadness (depression). This study is focusing specifically on the depressive periods.

We are looking at a new medicine, called Azetukalner, to see if it can help people who are experiencing depression related to Bipolar I or Bipolar II disorder. The main aim is to understand two key things: how safe the medicine is and how well it helps people's mood and well-being over time. This is a crucial step in developing new treatments.

By taking part, individuals could help us learn valuable information about Azetukalner. This knowledge might eventually help many other people in the future who are also living with bipolar depression. Every participant's contribution is very important in bringing new and better treatment options to those who need them.

Key takeaways

This study tests a new medicine for bipolar depression.
It aims to check safety and how well it works over a long time.
Participation requires you to be an adult with Bipolar I or II depression.
You'll receive close medical care and monitoring.
You can stop participating at any time.
Your involvement could help future patients.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important thing is that you have been diagnosed by a doctor with Bipolar I or Bipolar II disorder and are currently experiencing a depressive episode. This means you're feeling symptoms of depression that are affecting your daily life.

There might be other health conditions or medicines that would prevent someone from joining, as the researchers need to make sure the study is safe for everyone involved. Your study doctor will discuss all these details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Bipolar I or Bipolar II disorder?
Are you currently experiencing symptoms of depression?
Are you open to trying a new study medicine?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new study medicine, Azetukalner, for a long period under careful medical supervision. You would have regular visits to the clinic to meet with the study doctors and nurses. During these visits, they would check your health, ask about your mood and any symptoms you are having, and monitor for any side effects.

These checks might include questionnaires about your feelings, physical exams, and possibly blood tests. The team would always be available to answer your questions and support you throughout your time in the study. The exact number of visits and the total duration in the study would be explained in detail.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. A possible benefit here is that the new medicine, Azetukalner, might help to improve your symptoms of depression. You would also receive close medical attention and monitoring throughout the study. However, like all medicines, Azetukalner could have side effects, which might be mild or more serious. The research team will explain all known potential side effects to you. It's very important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Bulgaria
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Unverified
Germany
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Unverified
France
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Unverified
Spain

Common questions

What is Bipolar I or II Depression?

It's when you experience periods of low mood, sadness, and loss of interest as part of your Bipolar Disorder diagnosis.

What is Azetukalner?

It's the name of the new medicine being tested in this study to see if it helps with bipolar depression.

Is this a new medicine?

Yes, it's a new medicine currently being researched. It's not yet available to everyone.

How long will the study last?

This is a long-term study, meaning it will likely involve regular visits over an extended period. The exact duration for you will be explained by the study team.

Will I get free treatment?

Any study medication and medical care directly related to the study will be provided at no cost to you.