Xenon submits azetukalner NDA for focal seizures to FDA
Xenon Pharmaceuticals submitted a New Drug Application to the U.S. Food and Drug Administration for azetukalner to treat focal seizures, based on positive results from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials showing statistically significant reductions in monthly seizure frequency and a consistent safety profile across doses. The company reports over 1,500 patient-years of safety data and continues enrollment in Phase 3 X-TOLE3 and X-ACKT epilepsy studies. Separately, Xenon has temporarily paused new patient enrollment in its Phase 3 psychiatry trials after analysis of neuropsychiatric adverse events, while maintaining enrolled patients and planning topline MDD data in Q1 2027.
Company filed an FDA NDA for azetukalner in focal seizures.
Context
The company ran positive focal seizure trials and filed an NDA with the FDA. It then paused new psychiatry enrollment after reviewing neuropsychiatric adverse events and will evaluate dose changes. The FDA review and X-NOVA2 topline data…
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