Azetukalner in Adults With Focal Seizures: The X-TOLE2 Phase 3 Randomized Clinical Trial.

Azetukalner in adults with focal epilepsy reduced median monthly focal seizure frequency by -34.5% with 15 mg and -53.2% with 25 mg versus placebo over 12 weeks.

• Why it matters: Many adults with focal epilepsy continue having seizures despite 30+ approved antiseizure medications, leaving an unmet need for effective, well-tolerated new treatments.
• What they did: In a phase 3, 12-week double-blind randomized placebo-controlled trial at 138 sites, adults with 4+ focal seizures per month on 1–3 stable antiseizure medications received placebo or azetukalner 15 mg or 25 mg once daily without titration.
• The result: Median change from baseline in monthly seizure frequency was -10.4% for placebo, -34.5% for 15 mg (P<.001 vs placebo), and -53.2% for 25 mg (P<.001 vs placebo), with generally comparable treatment-emergent adverse events to phase 2b.

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