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Also known as XEN1101
Azetukalner · 11 trials · 9 indications
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
To assess the safety and tolerability of XEN1101
Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated, 10-item scale used to assess the severity of depressive symptoms. Each item is scored from 0 (normal/absent) to 6 (severe), yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. MADRS total score change from baseline at week 6.
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
| Arm | Type | Description |
|---|---|---|
| Azetukalner 20 mg | EXPERIMENTAL | - |
| Azetukalner | EXPERIMENTAL | Azetukalner 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| XEN1101 25 mg/day | EXPERIMENTAL | XEN1101 25 mg/day |
| XEN1101 15 mg/day | EXPERIMENTAL | XEN1101 15 mg/day |
| XEN1101 15 or 25 mg/day | EXPERIMENTAL | XEN1101 15 or 25 mg/day |
| XEN1101 10 mg | EXPERIMENTAL | During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day |
| XEN1101 20 mg | EXPERIMENTAL | During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day |
| 25 mg XEN1101 | EXPERIMENTAL | Capsule filled with 25 mg XEN1101 |
| 20 mg XEN1101 | EXPERIMENTAL | Capsule filled with 20 mg XEN1101 |
| 10 mg XEN1101 | EXPERIMENTAL | Capsule filled with 10 mg XEN1101 |
| Name | Type | Description |
|---|---|---|
| Azetukalner | DRUG | Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks. |
| Placebo | DRUG | Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks |
| XEN1101 | DRUG | XEN1101 Capsules |
| XEN1101 10 mg | DRUG | XEN1101 oral capsule |
| XEN1101 20 mg | DRUG | XEN1101 oral capsule |
Inclusion Criteria: * Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression. * Participant provides written informed consent to participate in the study, is able to understand the procedures and study req...
Azetukalner is an investigational small molecule drug in Phase 3 clinical development. It is being studied for bipolar depression, major depressive disorder, focal epilepsy, focal onset seizures, and primary generalized tonic-clonic seizures. Xenon Pharmaceuticals Inc. (ticker XENE) is developing it. It is not yet approved for any indication.
Azetukalner is being studied for several conditions: bipolar depression, bipolar I and II disorder, major depressive disorder, focal epilepsy, focal onset seizures, and primary generalized tonic-clonic seizures. All of these are investigational uses in Phase 3 trials. The drug does not currently have approval for any indication.
Azetukalner targets Kv7.2/7.3, a class of potassium channels. By acting on this molecular target, the drug is designed to modulate neuronal excitability. This mechanism underlies its investigation across both psychiatric conditions such as bipolar depression and major depressive disorder, and neurological conditions such as focal epilepsy and primary generalized tonic-clonic seizures.
Xenon Pharmaceuticals Inc., which trades under the ticker XENE, is developing azetukalner. The company is the sponsor of the Phase 3 clinical program evaluating the drug in bipolar depression, major depressive disorder, and seizure disorders.
Azetukalner is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for any indication. Four Phase 3 trials are registered, three currently active and one completed, with total planned enrollment of about 1,528 participants across the program.
Registered Phase 3 trials include NCT07217860, an open-label study in bipolar I or II depression (X-CEED-OLE); NCT07172516, a randomized placebo-controlled study in bipolar depression; NCT07076407, a randomized placebo-controlled study in major depressive disorder (X-NOVA3); and NCT06922110, an open-label study in major depressive disorder. All are listed as active but not recruiting.
Yes, azetukalner is also known as XEN1101, and the 10 mg dose is referred to as XEN1101 10 mg. These names refer to the same investigational compound developed by Xenon Pharmaceuticals Inc. for bipolar depression, major depressive disorder, and seizure disorders.