for developmental and epileptic encephalopathies caused by SCN2A and SCN8A variants
Originally SEP 27 2026; extended to DEC 27 2026 (FDA classified Praxis's submission of additional sensitivity analyses of existing clinical data as a 'major amendment' and extended review by 3 months. FDA cited no new safety or manufacturing concerns and requested no new clinical studies., announced JUN 29 2026).
Developmental and epileptic encephalopathies are severe seizure disorders that begin in infancy or early childhood and cause frequent, difficult-to-control seizures alongside developmental delays. Relutrigine is a selective sodium channel blocker that calms overactive nerve cells by targeting specific sodium channels in the brain. By stabilizing these channels, which are often faulty in these conditions, relutrigine may reduce seizure frequency and potentially improve developmental outcomes.
A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension
Source: ClinicalTrials.gov