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Xenon (XENE)
NASDAQ:XENE
Azetukalner
Bipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar Ii Disorder
Phase III
Enrolling By Invitation
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Oct 14, 2025
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Azetukalner
Bipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar Ii Disorder
Phase III
Recruiting
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Sep 08, 2025
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Azetukalner
Major Depressive Disorder
Phase III
Recruiting
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Jul 14, 2025
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Azetukalner
Major Depressive Disorder
Phase III
Enrolling By Invitation
An Open-Label Study of Azetukalner in Major Depressive Disorder
Mar 20, 2025
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Azetukalner
Major Depressive Disorder
Phase III
Recruiting
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Jan 09, 2025
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Xen1101
Focal Onset Seizures
Phase III
Recruiting
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Jan 26, 2023
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Xen1101
Focal Epilepsy, Tonic-Clonic Seizures
Phase III
Enrolling By Invitation
An Open-label Study of XEN1101 in Epilepsy
Jan 13, 2023
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Xen1101
Primary Generalized Tonic-Clonic Seizures
Phase III
Recruiting
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Dec 19, 2022
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Xen1101
Focal Onset Seizures
Phase III
Active Not Recruiting
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Nov 06, 2022
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Xen496
Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epilepsy In Children, Epilepsy; Seizure, Disease, Epileptic Syndromes
Phase III
Terminated
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
May 03, 2021
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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
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 (XENE) have in its pipeline
XENE is currently developing the following drugs: Azetukalner, Azetukalner, Azetukalner. These drug candidates are in various stages of clinical development as the company works toward FDA approval.