Name: Azetukalner (XEN1101) in Focal onset seizures: Phase of product development
Published: 2026-09-21T21:41:53-04:00

Regulatory submission: NDA submitted September 2026

“VANCOUVER, BC and BOSTON, MA, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need, today announced it has submitted a New Drug Application (NDA) for azetukalner in focal seizures (FS) to the U.S. Food and Drug Administration (FDA).” (opens the source at this quote in a new tab)
“We are very pleased to announce completion of the NDA submission for azetukalner in focal seizures in epilepsy.” (opens the source at this quote in a new tab)

Launch

No evidence found.

Investigational status: no approved product

“The Company has no products approved for sale and has not generated any revenue from product sales.” (opens the source at this quote in a new tab)

Pre-NDA meeting and planned submission quarter

“We remain on track to submit our New Drug Application (NDA) for azetukalner in FOS in the third quarter of 2026, having completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA).” (opens the source at this quote in a new tab)

Clinical basis of the New Drug Application

“The NDA submission is based on positive clinical data from two global, randomized, double-blind, placebo-controlled trials for azetukalner in focal seizures, including the Phase 2b X-TOLE study and Phase 3 X-TOLE2 study. Across the two studies, treatment with all four doses of azetukalner demonstrated a statistically significant reduction from baseline in monthly seizure frequency compared with placebo, and azetukalner was generally well-tolerated with a consistent safety profile observed in both studies. These safety results are comparable with the long-term safety observed in the X-TOLE open label extension (OLE) study, with the entire epilepsy program generating more than 1,500 patient-years of safety and exposure data.” (opens the source at this quote in a new tab)

Studies supporting submissions outside the United States and in a second seizure type

“The ongoing Phase 3 X-TOLE3 and X-ACKT studies of azetukalner in focal seizures and primary generalized tonic-clonic seizures (PGTCS), respectively, continue to enroll patients to support expansion of use across seizure types and global regions.” (opens the source at this quote in a new tab)

Japanese regulatory interaction

“In support of a potential regulatory submission in Japan, Xenon has completed an ethnobridging study and shared the results in a recent meeting with Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Xenon has aligned with PMDA to enroll approximately 60 of the planned 360 X-TOLE3 participants in Japan.” (opens the source at this quote in a new tab)

First-in-class positioning if approved

“If approved, azetukalner would be the only KV7 potassium channel opener available for the treatment of epilepsy.” (opens the source at this quote in a new tab)

Commercial readiness activities

“With a strong body of clinical evidence from two large placebo-controlled trials and more than 800 patient-years of exposure data, we are focusing next on submitting our new drug application to the FDA later this year, as well as advancing our commercial-readiness activities in anticipation of our first commercial launch.” (opens the source at this quote in a new tab)

FDA expedited program designations, filing acceptance, and action date

No evidence found.