azetukalner
azetukalner: developed by 1 company · 9 clinical trials tracked.
azetukalner evidence translation
What we can confirm
9 tracked trials
What it means
What to watch
Prepared research question
How could azetukalner → XENE affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (2)
| Company | Phase |
|---|---|
| Xenon Pharmaceuticals Inc. (XENE) Major Depressive Disorder; Bipolar Depression; Bipolar Disor… | Phase 3 |
| Xenon Pharmaceuticals Inc. (XENE) Focal Epilepsy; Focal Onset Seizures; Primary Generalized To… | Phase 3 |
Clinical Trials (9)
A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression
Primary endpoint: Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
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)
Primary endpoint: Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Primary endpoint: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
Primary endpoint: Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Primary endpoint: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Primary endpoint: Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Primary endpoint: The adverse events
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary endpoint: Median percent change (MPC) in monthly (28 days) PGTCS frequency
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Primary endpoint: Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Frequently asked questions
Who is developing azetukalner?
azetukalner is being developed by Xenon Pharmaceuticals Inc..
How many clinical trials involve azetukalner?
BioSniper tracks 9 clinical trials involving azetukalner.