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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

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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: 06 Mar 2026

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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

  • 26 Feb 2026 According to a Sarepta Therapeutics media release, the company will present topline results at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place March 8 - 11, 2026, in Orlando, Florida.
  • 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.

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