Evicenter
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Azetukalner (XEN1101)

Focal onset seizures

Regulatory submission
NDA submitted September 2026
Launch
Not announced
Last updated
163 sources

Product information and disease descriptionProduct descriptionProduct informationDosing and administration

Administration

3 evidence topics · 3 sources

Oral once-daily administration with food

“The X-TOLE2 clinical trial (NCT05614063) was a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the efficacy, safety, and tolerability of azetukalner, administered as an oral, adjunctive therapy once-daily with food in adult patients with FOS.” (opens the source at this quote in a new tab)

Rationale for administration with food and timing of the dose

“XEN1101 was administered as a once-daily adjunctive treatment in capsule formulation by mouth. Because the oral bioavailability of XEN1101 is enhanced by coadministration with food, patients were instructed to take the study medication with the evening meal.” (opens the source at this quote in a new tab)

Administration in the Phase 3 studies

“During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.” (opens the source at this quote in a new tab)