Name: Azetukalner (XEN1101) in Focal onset seizures: Dosage forms and strengths
Published: 2026-09-21T21:41:53-04:00

Product information and disease description Product description Product information

Dosage forms and strengths

4 evidence topics · 4 sources

Oral capsule formulation used in the Phase 2b study

“This was a multicenter, randomized, double-blind, parallel-group, dose-ranging, placebo-controlled adjunctive-therapy clinical trial in which XEN1101 was administered once daily with food as a 10-, 20-, or 25-mg oral capsule.” (opens the source at this quote in a new tab)

Immediate-release capsules used in Phase 1

“After single doses ranging from 5 to 30 mg (immediate-release capsules) administered in the fasting state, peak plasma azetukalner concentrations are achieved at 3.2–4.5 h on average.” (opens the source at this quote in a new tab)

Strengths evaluated in the Phase 3 focal seizure studies

“The completed X-TOLE2 study and the ongoing X-TOLE3 study were both designed as multicenter, randomized, double-blind, placebo-controlled studies to evaluate the clinical efficacy, safety, and tolerability of 15 mg or 25 mg of azetukalner administered orally with food as adjunctive treatment in approximately 360 patients per study with FOS.” (opens the source at this quote in a new tab)

Registry record of the dosage form

“XEN1101 Capsules” (opens the source at this quote in a new tab)