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SEP 30 2026
UPCOMING · 119 DAYS TO PDUFA

Praxis Precision Medicines relutrigine $PRAX

for developmental and epileptic encephalopathies caused by SCN2A and SCN8A variants

NDA · Priority Review · Orphan

Accepted MAR 30 2026.

About

Developmental and epileptic encephalopathies are severe seizure disorders that begin in infancy or childhood, often causing developmental delays, cognitive impairment, and frequent, hard-to-control seizures. Relutrigine is a selective sodium channel blocker that targets overactive SCN2A and SCN8A proteins, which can trigger excessive electrical activity in the brain. By calming these hyperactive channels, relutrigine may reduce seizure frequency and potentially improve developmental outcomes for affected children.

Pivotal trial

EMERALD Phase 3 recruiting NCT07010471

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