Xenon Submits Azetukalner NDA for Focal Seizures and Pauses New Enrollment in Its Depression Studies After Neuropsychiatric Adverse Events
Xenon Pharmaceuticals announced on Thursday, September 17, 2026 that it submitted a New Drug Application to the FDA for azetukalner, a Kv7 potassium channel opener, in focal seizures, supported by the Phase 2b X-TOLE and Phase 3 X-TOLE2 studies. The company also paused enrollment of new patients in its major depressive disorder and bipolar depression studies after an analysis of neuropsychiatric adverse events; the pause was put in place with its Data Safety Monitoring Board, is expected to be temporary, and does not affect enrolled participants. Xenon said the events were consistent with azetukalner's known safety and tolerability profile. X-NOVA2, its depression study, had enrolled about 80% of its initial 450-patient target, and topline data are now expected in the first quarter of 2027.