Product information and disease descriptionPlace of product in therapyApproaches to treatment
Place in treatment, anticipated use, and care setting
1 evidence topic · 5 sources
Summary
SL1009 is an investigational oral treatment with genotype-directed dosing. In the phase 3 study, participants continued ketogenic diets and other supplements; the available evidence therefore concerns use with background treatment rather than replacement of that care. The application remains under FDA review, with a target action date of December 30, 2026. Expanded access is physician-directed, and the published policy requires that the patient be ineligible for a clinical trial and that a licensed treating physician submit the request.