Core Insights - Xenon Pharmaceuticals Inc. is advancing its Phase 3 portfolio, particularly focusing on azetukalner for epilepsy and neuropsychiatry, with significant milestones expected in the near future [1][2] Phase 3 Azetukalner Program in Epilepsy & Depression - The topline data for the X-TOLE2 Phase 3 study of azetukalner in focal onset seizures (FOS) is anticipated in March 2026, followed by a New Drug Application (NDA) submission in the second half of 2026 [4] - Five additional Phase 3 studies of azetukalner are ongoing, targeting various indications in epilepsy and neuropsychiatry, with topline data from the X-NOVA2 study in major depressive disorder (MDD) expected in the first half of 2027 [4][5] - The X-TOLE2 study has completed enrollment with 380 patients, and the data collected will support the upcoming topline readout [5] Broader Pipeline Opportunity - Azetukalner is a novel KV7 potassium channel opener, currently in late-stage clinical trials for epilepsy, MDD, and bipolar depression (BPD), representing a significant advancement in treatment options [7][10] - The company is also developing early-stage candidates targeting NaV1.7 and KV7 for pain management, with preliminary Phase 1 data expected in 2026 to support Phase 2 studies [11][12] About Epilepsy and Focal Onset Seizures - Epilepsy affects approximately 3 million adults in the U.S., with focal onset seizures being a common form that presents a substantial unmet medical need due to the inadequacy of existing treatments for many patients [9]
Xenon Outlines Key Upcoming Milestones at the 2026 J.P. Morgan Healthcare Conference