Evicenter
P&T meetings

Azetukalner (XEN1101)

Focal onset seizures

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

Product information and disease descriptionProduct descriptionProduct information

Special populations

3 evidence topics · 2 sources

Adolescents in the generalized tonic-clonic seizure and open-label studies

“A similar trial ( NCT05667142 ) is being conducted in patients with generalized tonic-clonic seizures, assessing doses of 25 mg q.d. (participants aged ≥ 18 years) and 15 mg or 25 mg q.d (participants aged from 12 to < 18 years).” (opens the source at this quote in a new tab)

Age eligibility in the Phase 3 open-label extension

“This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.” (opens the source at this quote in a new tab)

Negligible renal elimination

“After 10 days of dosing at 25 mg q.d., only 0.01% of the administered dose is excreted in urine as unchanged drug over a 24 h collection period, indicating that azetukalner renal clearance is negligible” (opens the source at this quote in a new tab)

Hepatic impairment, renal impairment, pregnancy, and lactation

No evidence found.