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Azetukalner (XEN1101)

Focal onset seizures

Regulatory submission
NDA submitted September 2026
Launch
Not announced
Last updated
163 sources

Product information and disease descriptionProduct descriptionProduct information

Indication

3 evidence topics · 3 sources

Indication sought in the United States New Drug Application

“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)

Indication described at the Phase 3 readout

“Xenon plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of focal onset seizures in the third quarter of 2026.” (opens the source at this quote in a new tab)

Adjunctive use in adults, as studied in the registration trial

“A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures” (opens the source at this quote in a new tab)