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.
Focal Onset Seizures
DiseaseRelated News
FDA Clears First-in-Human Trial of Allogeneic Cell Therapy for Drug-Resistant Epilepsy
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.
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.
Praxis Submits Two NDAs to FDA, Reports $926M Cash Position and $303M Net Loss
Praxis Precision Medicines submitted NDAs for ulixacaltamide and relutrigine to the FDA, reported cash and investments of $926 million as of December 31, 2025, and disclosed a net loss of $303.3 million for full-year 2025.
Praxis Precision Medicines Submits Two NDAs, Reports $926M Cash Position
Praxis Precision Medicines has submitted new drug applications for ulixacaltamide in essential tremor and relutrigine in rare epilepsies, both granted Breakthrough Therapy Designation. The company reported $926 million in cash as of December 31, 2025.
Related Clinical Trials
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07141329 |
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures |
RECRUITING | PHASE2 |
| NCT06798896 |
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures |
RECRUITING | PHASE2 |
| NCT06377930 |
Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy |
COMPLETED | PHASE2 |
| NCT05716100 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) |
RECRUITING | PHASE3 |
| NCT05614063 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures |
COMPLETED | PHASE3 |
| NCT05473442 |
Study of EQU-001 for Uncontrolled Focal Onset Seizures |
TERMINATED | PHASE2 |
| NCT04836559 |
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy |
COMPLETED | PHASE2 |