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

Product information and disease description Product description Product information Dosing and administration

Dosage

3 evidence topics · 3 sources

Doses 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)

No titration at initiation or tapering at discontinuation

“Patients were randomized 2:1:1:2 to receive XEN1101, 25, 20, or 10 mg, or placebo with food once daily for 8 weeks. Dosage titration was not used.” (opens the source at this quote in a new tab)
“which enables gradual self-titration associated with a rapid onset of effect, with nearly the maximum seizure reduction achieved in each arm by the first week of treatment, which was sustained throughout the 8-week DBP in the 20- and 25-mg groups.” (opens the source at this quote in a new tab)

Dose used in long-term open-label treatment

“Participants who completed the DBP with a minimum of 80% study medication compliance and no important protocol deviations were eligible to enter the OLE phase, during which participants from all DBP arms began treatment with azetukalner 20 mg taken once daily with food (Figure 1 ). Azetukalner dose adjustments and changes in concomitant ASMs were allowed during the OLE.” (opens the source at this quote in a new tab)