Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension

Next Previous
Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Aug 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Azetukalner (Primary) ; Antiepileptic drugs
  • Indications Partial epilepsies; Seizures
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms X-TOLE
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 06 Aug 2026 According to a Xenon Pharmaceuticals media release, company remains on track to submit its 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).
  • 20 Apr 2026 According to a Xenon Pharmaceuticals media release, company presented positive data from the Phase 3 X-TOLE study highlighting the efficacy and safety of azetukalner in focal onset seizures (FOS) at the American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026 in Chicago, Illinois.
  • 20 Apr 2026 Results presented in the Xenon Pharmaceuticals media release.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top