Ireland
--:--IST
Priya Life Science Compound trial record
Compound · clinical trials

Azetukalner clinical trials

Also listed in trial records as XEN1101
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 9 trials in our USA, Germany, Spain, Poland, Italy, UK, France, Netherlands, Belgium, Austria, Czechia, Portugal, Canada, Mexico, Australia, Israel, Ireland and Japan registers that name Azetukalner as an intervention. Synced 10 Nov 2026
9Current trials
2Recruiting now
1Lead sponsor
18Country registers
At a glance

Azetukalner is named as an intervention in 9 current clinical trials in our USA, Germany, Spain, Poland, Italy, UK, France, Netherlands, Belgium, Austria, Czechia, Portugal, Canada, Mexico, Australia, Israel, Ireland and Japan registers. 2 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Xenon Pharmaceuticals Inc. The most-studied condition is Major Depressive Disorder.

How Azetukalner works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Bilateral tonic-clonic seizurePhase 3
  • Focal-onset seizurePhase 3
  • Bipolar disorderPhase 3
  • Major depressive disorderPhase 3
  • Focal epilepsyPhase 2
  • EpilepsyPhase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5095264, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12650, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Azetukalner

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting222%
  • Active, closed667%
  • By invitation111%

Trials by phase

  • Phase 3889%
  • Phase 2111%
01

Clinical trials of Azetukalner

9 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
NCT05667142 · Primary Generalized Tonic-Clonic Seizures
Phase 3 Recruiting Xenon Pharmaceuticals Inc UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Canada, Mexico, Australia, Israel
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
NCT05716100 · Focal Onset Seizures
Phase 3 Recruiting Xenon Pharmaceuticals Inc USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Mexico, Japan, Australia, Israel
An Open-label Study of XEN1101 in Epilepsy
NCT05718817 · Focal Epilepsy, Tonic-Clonic Seizures
Phase 3 By invitation Xenon Pharmaceuticals Inc Ireland, UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Canada, Mexico, Australia, Israel
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
NCT06775379 · Major Depressive Disorder
Phase 3 Active, closed Xenon Pharmaceuticals Inc USA
An Open-Label Study of Azetukalner in Major Depressive Disorder
NCT06922110 · Major Depressive Disorder
Phase 3 Active, closed Xenon Pharmaceuticals Inc USA, Poland
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
NCT07076407 · ClinicalTrials.gov ↗ · Major Depressive Disorder
Phase 3 Active, closed Xenon Pharmaceuticals Inc USA, Germany, Spain, Poland
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
NCT07172516 · ClinicalTrials.gov ↗ · Bipolar Disorder, Bipolar Depression, Bipolar I Disorder
Phase 3 Active, closed Xenon Pharmaceuticals Inc USA, Germany, Spain
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
NCT07217860 · ClinicalTrials.gov ↗ · Bipolar Depression, Bipolar I Disorder, Bipolar Disorder
Phase 3 Active, closed Xenon Pharmaceuticals Inc USA
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
NCT03796962 · Focal Epilepsy
Phase 2 Active, closed Xenon Pharmaceuticals Inc UK, USA, Germany, Spain, Italy, Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Azetukalner

9 conditions
Major Depressive Disorder3Focal Epilepsy2Bipolar Disorder2Bipolar Depression2Bipolar I Disorder2Bipolar II Disorder2Tonic-Clonic Seizures1Primary Generalized Tonic-Clonic Seizures1Focal Onset Seizures1
05

Related compounds

06

Questions about Azetukalner trials

How many clinical trials are testing Azetukalner?

9 current trials in our USA, Germany, Spain, Poland, Italy, UK, France, Netherlands, Belgium, Austria, Czechia, Portugal, Canada, Mexico, Australia, Israel, Ireland and Japan registers name Azetukalner (also registered as XEN1101) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Azetukalner trials recruiting patients?

Yes. 2 of the 9 trials are recruiting: 2 with sites in USA, 2 with sites in Germany, 2 with sites in Spain, 2 with sites in Poland, 2 with sites in Italy, 1 with sites in UK, 2 with sites in France, 2 with sites in Netherlands, 2 with sites in Belgium, 2 with sites in Austria, 2 with sites in Czechia, 2 with sites in Portugal, 1 with sites in Canada, 2 with sites in Mexico, 2 with sites in Australia, 2 with sites in Israel and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Azetukalner clinical trials?

The lead sponsor is Xenon Pharmaceuticals Inc. The number in brackets is how many trials each organisation leads.

Are there Azetukalner clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Azetukalner works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Azetukalner works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Azetukalner (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.