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Xenon (XENE) Drug Pipeline

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Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
AzetukalnerBipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar Ii DisorderPhase IIIEnrolling By InvitationAn Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)Oct 14, 2025―
AzetukalnerBipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar Ii DisorderPhase IIIRecruitingA Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)Sep 08, 2025―
AzetukalnerMajor Depressive DisorderPhase IIIRecruitingA Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)Jul 14, 2025―
AzetukalnerMajor Depressive DisorderPhase IIIEnrolling By InvitationAn Open-Label Study of Azetukalner in Major Depressive DisorderMar 20, 2025―
AzetukalnerMajor Depressive DisorderPhase IIIRecruitingA Randomized Study of Azetukalner Versus Placebo in Major Depressive DisorderJan 09, 2025―
Xen1101Focal Onset SeizuresPhase IIIRecruitingA Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)Jan 26, 2023―
Xen1101Focal Epilepsy, Tonic-Clonic SeizuresPhase IIIEnrolling By InvitationAn Open-label Study of XEN1101 in EpilepsyJan 13, 2023―
Xen1101Primary Generalized Tonic-Clonic SeizuresPhase IIIRecruitingA Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic SeizuresDec 19, 2022―
Xen1101Focal Onset SeizuresPhase IIIActive Not RecruitingA Randomized Study of XEN1101 Versus Placebo in Focal-Onset SeizuresNov 06, 2022―
Xen496Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epilepsy In Children, Epilepsy; Seizure, Disease, Epileptic SyndromesPhase IIITerminatedAn Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEEMay 03, 2021―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Xenon Pharmaceuticals (XENE) have in its pipeline
Xenon XENE is currently developing the following drugs: Azetukalner, Xen1101, Xen496. These drug candidates are in various stages of clinical development as the company works toward FDA approval.