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azetukalner

Generic: Azetukalner

azetukalner: sourced relationships with 1 company · 10 clinical trials tracked.

azetukalner evidence translation

What we can confirm

What it means

Source-backed records connect azetukalner to XENE; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could azetukalner → XENE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

Focal Epilepsy; Major Depressive Disorder; Focal Onset SeizuresBipolar DisorderFocal EpilepsyMajor Depressive Disorder

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Xenon Pharmaceuticals Inc. (XENE)
licensee · Reported 2024-02-29 · Current development: unknownSource
Focal Epilepsy; Major Depressive Disorder; Focal Onset Seizu…
Phase 2
Clinical Trial Registry Records (10)

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

NCT07217860Registry updated 2026-10-13·Phase 3·XENE
Active, not recruiting

Primary endpoint: Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest

Interventionalopen400 targetStarted 2025-10Completion 2029-0820 sites · United StatesXenon Pharmaceuticals Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516Registry updated 2026-10-13·Phase 3·XENE
Active, not recruiting

Primary endpoint: Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.

InterventionalRandomizedquadruple400 targetStarted 2025-08Completion 2028-0844 sites · Bulgaria, Germany, Spain, United StatesXenon Pharmaceuticals Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

NCT07076407Registry updated 2026-09-08·Phase 3·XENE
Recruiting

Primary endpoint: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

InterventionalRandomizedquadruple450 targetStarted 2025-07Completion 2027-0750 sites · Finland, Germany, Poland, Romania…Xenon Pharmaceuticals Inc.

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

NCT06922110Registry updated 2026-10-13·Phase 3·XENE
Active, not recruiting

Primary endpoint: Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest

Interventionalopen460 targetStarted 2025-03Completion 2027-0371 sites · Finland, Poland, United StatesXenon Pharmaceuticals Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

NCT06775379Registry updated 2026-10-13·Phase 3·XENE
Active, not recruiting

Primary endpoint: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

InterventionalRandomizedquadruple450 targetStarted 2024-12Completion 2026-1245 sites · United StatesXenon Pharmaceuticals Inc.

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

NCT05716100Registry updated 2026-10-08·Phase 3·XENE
Recruiting

Primary endpoint: Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

InterventionalRandomizeddouble360 targetStarted 2023-05Completion 2028-0398 sites · Argentina, Australia, Austria, Belgium…Xenon Pharmaceuticals Inc.

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy

NCT05718817Registry updated 2026-10-08·Phase 3·XENE
Enrolling by invitation

Primary endpoint: The adverse events

Interventionalopen880 targetStarted 2023-04Completion 2033-06152 sites · Argentina, Australia, Austria, Belgium…Xenon Pharmaceuticals Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

NCT05667142Registry updated 2026-10-08·Phase 3·XENE
Recruiting

Primary endpoint: Median percent change (MPC) in monthly (28 days) PGTCS frequency

InterventionalRandomizeddouble160 targetStarted 2023-02Completion 2027-06138 sites · Argentina, Australia, Austria, Belgium…Xenon Pharmaceuticals Inc.

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

NCT05614063Registry updated 2026-05-14·Phase 3·XENE
Completed

Primary endpoint: Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

InterventionalRandomizeddouble380 enrolledStarted 2022-11Completion 2026-0250 sites · United StatesXenon Pharmaceuticals Inc.

A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder

NCT05376150Registry updated 2026-09-21·Phase 2·XENE
Completed

Primary endpoint: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score.

InterventionalRandomizeddouble168 enrolledStarted 2022-05Completion 2023-1020 sites · United StatesXenon Pharmaceuticals Inc.

Frequently asked questions

Which companies have sourced relationships with azetukalner?

azetukalner has dated SEC/FDA relationship records for Xenon Pharmaceuticals Inc..

How many clinical trials involve azetukalner?

BioSniper tracks 10 clinical trials involving azetukalner.