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# Clinical Hold Removed on Dravet Syndrome Drug
- URL: https://www.fdaweb.com/clinical-hold-removed-on-dravet-syndrome-drug/
- Published: 2024-08-13T12:00:00.000Z
- Updated: 2026-09-14T14:38:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157566

FDA has removed a partial clinical hold on Stoke Therapeutics’ zorevunersen (STK-001) and its use in children and adolescents with Dravet syndrome. The therapy was under a modified partial hold since 3/2023 that allowed the administration of a single dose of STK-001 (70 mg) in its ongoing Phase 1-2 MONARCH study. Now that the hold is removed, the company says it will advance zorevunersen’s clinical program into a Phase 3 registrational study by year-end.

STK-001 is described as a proprietary antisense oligonucleotide, and the first potential new medicine to address the genetic cause of Dravet syndrome, which is a genetic form of epilepsy characterized by frequent, prolonged and refractory seizures that begin during the first year of life. Current anti-seizure medicines do not adequately control the seizures, the company says.