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# Praxis Relutrigine NDA Accepted for Rare Pediatric Epilepsies
- URL: https://www.fdaweb.com/praxis-relutrigine-nda-accepted-for-rare-pediatric-epilepsies/
- Published: 2026-03-30T12:00:00.000Z
- Updated: 2026-09-14T13:36:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160900

FDA has accepted for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare genetic epilepsies. The agency set a user fee review action target date of 9/27.

Relutrigine is being developed to treat developmental and epileptic encephalopathies (DEEs) caused by mutations in the SCN2A and SCN8A genes — severe neurological disorders that begin in infancy or early childhood and are associated with frequent, difficult-to-control seizures and high mortality, according to the company. There are currently no approved targeted therapies for these conditions.

The NDA is supported by data from the Phase 2 EMBOLD study, which was halted early after an interim analysis indicated efficacy, following a recommendation from an independent data monitoring committee.

According to Praxis, relutrigine demonstrated improvements in motor seizure control in a heavily pretreated patient population, with some patients achieving sustained seizure freedom. The therapy has also been generally well-tolerated across clinical studies to date.

Relutrigine is designed as a first-in-class small molecule that selectively inhibits persistent sodium current, a mechanism believed to drive neuronal hyperexcitability and seizures in severe epileptic disorders, Praxis says. Preclinical studies have shown dose-dependent seizure control, including complete suppression in animal models of SCN2A- and SCN8A-related disease.