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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2026

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At a glance

  • Drugs Azetukalner (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms X-TOLE2
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 17 Sep 2026 According to a Xenon Pharmaceuticals media release, based on the data from X-TOLE and X-TOLE2 studies, the company has submitted a New Drug Application (NDA) for azetukalner in focal seizures (FS) to the U.S. Food and Drug Administration (FDA).
  • 27 Aug 2026 According to a Xenon Pharmaceuticals media release, the company to present data form this trial at the upcoming 16th European Epilepsy Congress (EEC), taking place September 5-9, 2026, in Athens, Greece.
  • 06 Aug 2026 According to a Xenon Pharmaceuticals media release, company presented topline efficacy and safety results from the Phase 3 X-TOLE2 study at the Epilepsy Foundation Pipeline Conference in Leesburg, Virginia from June 18-19.

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