XEN1101
Xenon Pharmaceuticals Inc. XENE · Focal Onset Seizures; Focal Epilepsy; Primary Generalized Tonic-Clonic Seizures; Tonic-Clonic Seizures
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Xenon Pharmaceuticals Inc. XENE Source: Company record for Xenon Pharmaceuticals Inc. (opens in a new tab)
- Indications
- Focal Onset Seizures; Focal Epilepsy; Primary Generalized Tonic-Clonic Seizures; Tonic-Clonic Seizures Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 18 Nov 20224 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for XEN1101. Editors add each one with its source.
Filed application
No filed application is on record for XEN1101. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for XEN1101.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05716100ClinicalTrials.gov record for NCT05716100 (opens in a new tab) | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) | Phase 3 | Recruiting | 360 (estimated) | Jan 2028 (estimated) | No |
| NCT05718817ClinicalTrials.gov record for NCT05718817 (opens in a new tab)X-TOLE4 | An Open-label Study of XEN1101 in Epilepsy | Phase 3 | Enrolling by invitation | 880 (estimated) | Apr 2033 (estimated) | No |
| NCT05667142ClinicalTrials.gov record for NCT05667142 (opens in a new tab)X-ACKT | A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures | Phase 3 | Recruiting | 160 (estimated) | Apr 2027 (estimated) | No |
| NCT05614063ClinicalTrials.gov record for NCT05614063 (opens in a new tab)X-TOLE2 | A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures | Phase 3 | Completed | 380 (actual) | 12 Jan 2026 (actual) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as XEN1101.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT05718817 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05716100 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05667142 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05614063 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.