New Drug Application Submitted for Azetukalner in Focal Seizures
November 9, 2026 - 21:06
In September 2026, a New Drug Application for azetukalner, a treatment for focal seizures, was submitted to the U.S. Food and Drug Administration. This marks a significant step forward in expanding the options available for epilepsy patients. The company is currently conducting two ongoing Phase 3 studies, X-TOLE3 and X-ACKT, which aim to further assess the drug's efficacy and safety.
a Phase 3b/4 study, named X-FIRST, is set to begin in the first quarter of 2027. This study will evaluate azetukalner as a first add-on antiseizure medication, potentially enhancing treatment strategies for those who do not achieve control with monotherapy.
Enrollment for the Phase 3 X-NOVA2 study, which focuses on azetukalner's application in major depressive disorder, has been completed. Topline data from this study is anticipated in December 2026, offering insights into the drug's broader therapeutic potential.
Positive Phase 1 data has also been reported for XEN170, a novel non-opioid pain program, indicating promising developments in pain management options.
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