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.
Also known as: Xenon Pharmaceuticals
Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. Its pipeline includes azetukalner and other ion-channel programs for epilepsy, mood disorders, and pain.
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.
The FDA has authorized the first human trial of an allogeneic stem cell therapy for epilepsy, developed by Shanghai-based Unixell Biotechnology. The therapy uses donor-derived stem cells to produce GABA and suppress seizures in drug-resistant patients.
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
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.
| 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 |
| NCT05718817 |
An Open-label Study of XEN1101 in Epilepsy |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT05716100 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) |
RECRUITING | PHASE3 |
| NCT05667142 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures |
RECRUITING | PHASE3 |
| NCT05614063 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures |
COMPLETED | PHASE3 |
| NCT05376150 |
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder |
COMPLETED | PHASE2 |