Trial Profile

A Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 21 Nov 2025

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At a glance

Drugs Casimersen (Primary) ; Golodirsen (Primary)
Indications Duchenne muscular dystrophy
Focus Registrational; Therapeutic Use
Acronyms ESSENCE
Sponsors Sarepta Therapeutics

Most Recent Events

18 Nov 2025 Status changed from active, no longer recruiting to completed.
03 Nov 2025 According to Sarepta Therapeutics media release, the company intends to schedule a meeting with FDA to discuss path to a traditional approval based on the positive risk-benefits of the therapies from the results of the trial.
03 Nov 2025 Primary endpoint has not been met. (Change From Baseline in the 4-Step Ascend Velocity at Week 96)

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