Xenon Pharmaceuticals Inc. (XENE)
Xenon Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company dedicated to discovering and advancing innovative treatments for individuals living with neurological disorders. The company operates primarily from its headquarters in Burnaby, Canada. Its robust clinical pipeline showcases several promising candidates: XEN496, an activator of Kv7 potassium channels, is currently in Phase III clinical trials for KCNQ2 developmental and epileptic encephalopathy. Another Kv7 potassium channel activator, XEN1101, is progressing through Phase II trials, targeting epilepsy and a range of other neurological conditions. The portfolio also includes NBI-921352, a selective inhibitor of the Nav1.6 sodium channel, which is undergoing Phase II clinical evaluation for SCN8A developmental and epileptic encephalopathy, alongside investigations for adult focal epilepsy and other potential indications. Furthermore, XEN007, a central nervous system-acting calcium channel modulator, is also in Phase II development. Beyond its internal development, Xenon Pharmaceuticals has established strategic collaborations. This includes a licensing and development agreement with Neurocrine Biosciences, Inc. focused on epilepsy treatments, and a partnership with Flexion Therapeutics, Inc. to advance PCRX301 (also known as XEN402), a Nav1.7 inhibitor, for post-operative pain management. Established in 1996, the company continues its mission to address significant unmet medical needs in neurology.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Xenon Pharmaceuticals Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Terminated
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
XEN496, Placebo
Epilepsy, Epilepsy in Children +6
NCT04639310Enrollment8StartMar 2021Primary CompletionMay 2023CompletionMay 2023 - Phase 3Terminated
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
XEN496
Epilepsy, Epilepsy in Children +6
NCT04912856Enrollment8StartAug 2021Primary CompletionNov 2023CompletionNov 2023 - Phase 3Completed
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
XEN1101, Placebo
Focal Onset Seizures
NCT05614063Enrollment380StartNov 2022Primary CompletionJan 2026CompletionFeb 2026 - Phase 3Recruiting
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
XEN1101, Placebo
Primary Generalized Tonic-Clonic Seizures
NCT05667142Enrollment160StartFeb 2023Primary CompletionApr 2027est.CompletionJun 2027est. - Phase 3Recruiting
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
XEN1101, Placebo
Focal Onset Seizures
NCT05716100Enrollment360StartMay 2023Primary CompletionJan 2028est.CompletionMar 2028est. - Phase 3Enrolling by invitation
An Open-label Study of XEN1101 in Epilepsy
XEN1101
Focal Epilepsy, Tonic-Clonic Seizures
NCT05718817Enrollment880StartApr 2023Primary CompletionApr 2033est.CompletionJun 2033est. - Phase 3Active, not recruiting
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Azetukalner, Placebo
Major Depressive Disorder
NCT06775379Enrollment450StartDec 2024Primary CompletionOct 2026est.CompletionDec 2026est. - Phase 3Active, not recruiting
An Open-Label Study of Azetukalner in Major Depressive Disorder
Azetukalner
Major Depressive Disorder
NCT06922110Enrollment460StartMar 2025Primary CompletionJan 2027est.CompletionMar 2027est. - Phase 3Active, not recruiting
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Azetukalner, Placebo
Major Depressive Disorder
NCT07076407Enrollment450StartJul 2025Primary CompletionMay 2027est.CompletionJul 2027est. - Phase 3Active, not recruiting
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Azetukalner, Placebo
Bipolar Disorder, Bipolar Depression +2
NCT07172516Enrollment400StartAug 2025Primary CompletionJun 2028est.CompletionAug 2028est. - Phase 3Active, not recruiting
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Azetukalner
Bipolar Depression, Bipolar I Disorder +2
NCT07217860Enrollment400StartOct 2025Primary CompletionJun 2029est.CompletionAug 2029est. - Phase 2Completed
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
XPF-001, placebo
Dental Pain
NCT00954356Enrollment61StartSep 2009Primary CompletionNov 2009CompletionDec 2009 - Phase 2Completed
A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
XPF-002, Placebo
Postherpetic Neuralgia
NCT01195636Enrollment70StartAug 2010Primary CompletionMar 2011CompletionMar 2011 - Phase 2Active, not recruiting
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
XEN1101
Focal Epilepsy
NCT03796962Enrollment325StartJan 2019Primary CompletionSep 2021CompletionOct 2028est. - Phase 2Completed
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
XEN1101 10 mg, XEN1101 20 mg
Major Depressive Disorder
NCT05376150Enrollment168StartMay 2022Primary CompletionSep 2023CompletionOct 2023 - Phase 1/2Completed
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
XPF-001, Placebo
Primary Erythromelalgia, Inherited Erythromelalgia
NCT01090622Enrollment4StartApr 2010Primary CompletionAug 2010CompletionSep 2010 - Phase 1/2Completed
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
XPF-002, Placebo
Primary Erythromelalgia, Inherited Erythromelalgia
NCT01486446Enrollment8StartDec 2011Primary CompletionApr 2012CompletionMay 2012 - Phase 1/2Completed
A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
XPF-005, Placebo
Acne Vulgaris
NCT02656043Enrollment213StartSep 2015Primary CompletionFeb 2017CompletionMar 2017 - Phase 1Completed
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
XPF-001
Healthy Human Volunteers
NCT00813670Enrollment64StartNov 2008Primary CompletionMay 2009CompletionJul 2009 - Phase 1Completed
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.
XPF-008, Microcrystalline Cellulose
Healthy Volunteers
NCT03340220Enrollment130StartNov 2017Primary CompletionNov 2021CompletionNov 2021 - Phase 1Completed
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
XEN901, Inert Ingredients Oral Product
Healthy Volunteers
NCT03467100Enrollment70StartFeb 2018Primary CompletionDec 2018CompletionDec 2018 - Phase 1Completed
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
XPF-008, Microcrystalline Cellulose
Healthy Male Volunteers
NCT03468725Enrollment20StartFeb 2018Primary CompletionJul 2018CompletionJul 2018 - Phase 1Completed
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
14C-XEN1101
Healthy Volunteers
NCT04952467Enrollment6StartJul 2021Primary CompletionOct 2021CompletionOct 2021
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Terminated | XEN496, Placebo | NCT04639310 |
| Phase 3 | Terminated | XEN496 | NCT04912856 |
| Phase 3 | Completed | XEN1101, Placebo | NCT05614063 |
| Phase 3 | Recruiting | XEN1101, Placebo | NCT05667142 |
| Phase 3 | Recruiting | XEN1101, Placebo | NCT05716100 |
| Phase 3 | Enrolling by invitation | XEN1101 | NCT05718817 |
| Phase 3 | Active, not recruiting | Azetukalner, Placebo | NCT06775379 |
| Phase 3 | Active, not recruiting | Azetukalner | NCT06922110 |
| Phase 3 | Active, not recruiting | Azetukalner, Placebo | NCT07076407 |
| Phase 3 | Active, not recruiting | Azetukalner, Placebo | NCT07172516 |
| Phase 3 | Active, not recruiting | Azetukalner | NCT07217860 |
| Phase 2 | Completed | XPF-001, placebo | NCT00954356 |
| Phase 2 | Completed | XPF-002, Placebo | NCT01195636 |
| Phase 2 | Active, not recruiting | XEN1101 | NCT03796962 |
| Phase 2 | Completed | XEN1101 10 mg, XEN1101 20 mg | NCT05376150 |
| Phase 1/2 | Completed | XPF-001, Placebo | NCT01090622 |
| Phase 1/2 | Completed | XPF-002, Placebo | NCT01486446 |
| Phase 1/2 | Completed | XPF-005, Placebo | NCT02656043 |
| Phase 1 | Completed | XPF-001 | NCT00813670 |
| Phase 1 | Completed | XPF-008, Microcrystalline Cellulose | NCT03340220 |
| Phase 1 | Completed | XEN901, Inert Ingredients Oral Product | NCT03467100 |
| Phase 1 | Completed | XPF-008, Microcrystalline Cellulose | NCT03468725 |
| Phase 1 | Completed | 14C-XEN1101 | NCT04952467 |