A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Summary

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Timeline

Start

2022-11-18

Primary completion

2026-01-12

Completion

2026-02-03

Outcome

Met primary endpoint

release “X-TOLE2 met primary endpoint in both dose groups” xenon-pharma.com ↗

release “Xenon announced positive topline data from the Phase 3 X-TOLE2 study in March 2026. The study met its primary endpoint” xenon-pharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azetukalner	Small molecule	15 mg	Oral
Subject	Azetukalner	Small molecule	25 mg	Oral

Indications