Drugs / Elsunersen
last change Jun 2026 re-read 3 minutes ago

Elsunersen

Developed for
genetic developmental and epileptic encephalopathy
Investigated by
Praxis Precision Medicines

Trials 1

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT07019922 Aug 2025 → Jun 2026 overdue genetic developmental and epileptic encephalopathy Praxis Precision Medicines Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-06-22 Praxis Precision Medicines Regulatory Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants praxismedicines.com ↗
The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen
2026-04-06 Praxis Precision Medicines Results Praxis Precision Medicines Announces Positive Results from the EMBRAVE Part A Trial of Elsunersen in Patients with SCN2A Early-Onset Developmental and Epileptic Encephalopathy praxismedicines.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Elsunersen ClinicalTrials.gov intervention name — accepted as the source's own label NCT07019922 ↗
Route Intrathecal “intrathecally” NCT07019922 ↗