Developer · XENE · Canada
Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Burnaby, British Columbia, focused on developing small-molecule ion-channel therapeutics for neurological disorders such as epilepsy and major depressive disorder. Its lead candidate is the Kv7 potassium channel opener azetukalner (XEN1101).
Pipeline (1)
- EpilepsyPhase 3Active
- Major depressive disorderPhase 3Recruiting
- Bipolar depressionPhase 3Recruiting
Deals & partnerships
- Azetukalner (XEN1101)Licensor 1st Order Pharmaceuticals, Inc.Licensor Bausch Health Companies Inc.
- Sep 10, 2018Option exerciseXenon buys out XEN1101 milestones and royalties from Valeant/Bausch Health subsidiariesOn September 10, 2018, Xenon agreed to pay a one-time $6.0 million lump sum to Valeant Pharmaceuticals Luxembourg S.a.r.l. and Valeant Pharmaceuticals Ireland Limited (indirect subsidiaries of Bausch Health Companies Inc.) to terminate up to $39.6 million in potential clinical, regulatory and sales-based milestones and a mid-to-high single-digit royalty on commercial sales of XEN1101, the inherited obligations tied to the prior Valeant ownership of the compound.
- Apr 25, 2017Licensing dealXenon acquires worldwide rights to XEN1101 from 1st Order PharmaceuticalsUnder an asset purchase agreement dated April 25, 2017 (announced April 26, 2017), Xenon acquired worldwide development and commercialization rights to XEN1101 (azetukalner), a next-generation Kv7 potassium channel opener, from 1st Order Pharmaceuticals, Inc. 1st Order had previously acquired the asset (then 1OP2198) from an affiliate of Valeant Pharmaceuticals. Terms included an upfront fee plus contingent clinical, regulatory and sales-based milestones (up to roughly $8M to 1st Order) and royalties on commercial sales.
Catalysts · 3 upcoming · 1 reported
- Q3 2026Anticipated
Azetukalner (XEN1101)forEpilepsyRegulatory
FDA NDA submission for azetukalner in focal onset seizures planned for Q3 2026.
- 2H 2026Anticipated
Azetukalner (XEN1101)forEpilepsyTopline data
X-TOLE3 Phase 3 topline (second pivotal focal-onset-seizure trial) anticipated; primary completion ~Oct 2026.
- 2028Anticipated
Azetukalner (XEN1101)forBipolar depressionTopline data
X-CEED Phase 3 topline in bipolar I/II depression (MADRS at Week 6) anticipated
Recently reported
- 2026-03-09met
Azetukalner (XEN1101)forEpilepsyTopline data
X-TOLE2 Phase 3 POSITIVE: azetukalner cut monthly focal-onset seizure frequency -53.2% at 25 mg (placebo-adjusted -42.7%, p=6e-12) vs -10.4% placebo; supports Q3 2026 NDA.
Recent activity
- Mar 9, 2026ReadoutAzetukalner (XEN1101)·EpilepsymetX-TOLE2 Phase 3 POSITIVE: azetukalner cut monthly focal-onset seizure frequency -53.2% at 25 mg (placebo-adjusted -42.7%, p=6e-12) vs -10.4% placebo; supports Q3 2026 NDA.source ↗
- Aug 8, 2025Phase changeAzetukalner (XEN1101)·Bipolar depressionPhase 3Phase 3 bipolar depression program initiated; X-CEED (NCT07172516) began enrolling (actual study start 2025-08-08). X-CEED is the first of two planned Phase 3 BPD efficacy trials.source ↗
- Dec 20, 2024Phase changeAzetukalner (XEN1101)·Major depressive disorderPhase 3Phase 3 MDD program initiated (X-NOVA2, then X-NOVA3).source ↗
- Sep 18, 2023Phase changeAzetukalner (XEN1101)·Major depressive disorderPhase 2Phase 2 X-NOVA completed; MADRS 20 mg vs placebo difference 3.04 (p=0.135), significant week-1 separation + anhedonia benefit.source ↗
- Nov 18, 2022Phase changeAzetukalner (XEN1101)·EpilepsyPhase 3Pivotal Phase 3 focal-epilepsy program initiated: X-TOLE2 (NCT05614063) first-patient-in 2022-11-18, followed by X-TOLE3 (NCT05716100, start 2023-05-09).source ↗
- Oct 4, 2021Phase changeAzetukalner (XEN1101)·EpilepsyPhase 2Phase 2b X-TOLE (NCT03796962) positive topline: met primary endpoint with statistically significant, dose-dependent reduction in monthly focal seizure frequency (52.8% at 25 mg, p<0.001) vs placebo. Primary completion 2021-09-02.source ↗
Trials recruiting · 4 recruiting of 8 sponsored
- Phase 3Azetukalner (XEN1101)
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)
- Phase 3Azetukalner (XEN1101)
Phase 3 Study of Azetukalner in Moderate-to-Severe Major Depressive Disorder (X-NOVA3)
- Phase 3Azetukalner (XEN1101)
Phase 3 Study of Azetukalner in Moderate-to-Severe Major Depressive Disorder (X-NOVA2)
- Phase 3Azetukalner (XEN1101)
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Competitive landscape
Other companies developing against Xenon Pharmaceuticals Inc.'s targets or indications.
- Biohaven Ltd.1 compoundKv7.2EpilepsyMajor depressive disorder
- Alto Neuroscience, Inc.3 compoundsMajor depressive disorderBipolar depression
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorderBipolar depression
- Cerevel Therapeutics Holdings, Inc.2 compoundsEpilepsyMajor depressive disorder
- Intra-Cellular Therapies, Inc.1 compoundMajor depressive disorderBipolar depression
- LB Pharmaceuticals Inc.1 compoundMajor depressive disorderBipolar depression
- Axsome Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
- Boehringer Ingelheim International GmbH2 compoundsMajor depressive disorder
- COMPASS Pathways plc1 compoundMajor depressive disorder
- CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.1 compoundMajor depressive disorder
- Definium Therapeutics, Inc.1 compoundMajor depressive disorder
