Phase III X-TOLE2 data support azetukalner filing in focal onset seizures
Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.
Azetukalner
DrugDrug Profile
Azetukalner (XEN1101, also known as encukalner) is an experimental small-molecule potassium channel opener in late-stage clinical development for focal onset seizures and other neuropsychiatric indications. It acts on Kv7.2/Kv7.3 channels to reduce neuronal excitability. As of March 2026 it remained unapproved, with planned U.S. NDA submission later in 2026.
- Drug Class
- Small-molecule anticonvulsant; selective Kv7.2/Kv7.3 potassium channel opener
- Approval Status
- Investigational; not yet approved, with NDA submission to FDA anticipated in Q3 2026
- Mechanism of Action
- Positive allosteric modulation/opening of KCNQ2/3 (Kv7.2/Kv7.3) voltage-gated potassium channels, increasing potassium efflux and neuronal hyperpolarization
- \Focal onset seizures (investigational)\
- \Major depressive disorder (investigational)\
- \Bipolar depression (investigational)\
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Xenon Pharmaceuticals to Report Phase 3 Epilepsy Trial Results for Azetukalner
Xenon Pharmaceuticals will announce topline data from its Phase 3 X-TOLE2 study of azetukalner in patients with focal onset seizures on March 9, 2026, during a conference call at 8:00 a.m. ET.
Related Clinical Trials
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07217860 |
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE) |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT07172516 |
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) |
RECRUITING | PHASE3 |
| NCT07076407 |
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) |
RECRUITING | PHASE3 |
| NCT06922110 |
An Open-Label Study of Azetukalner in Major Depressive Disorder |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT06775379 |
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder |
RECRUITING | PHASE3 |