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A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

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Trial Profile

A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2024

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At a glance

  • Drugs Delandistrogene moxeparvovec (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARK
  • Sponsors Sarepta Therapeutics

    • Most Recent Events

    • 07 Aug 2024 According to a Sarepta Therapeutics media release, data from this trial will be presented at the 29th Annual Congress of the World Muscle Society (WMS 2024)
    • 20 Jun 2024 According to a Sarepta Therapeutics media release, company will host an investor conference call on June 21, 2024, at 8:30 a.m. ET to discuss this update.
    • 20 Jun 2024 According to a Sarepta Therapeutics media release, company announced U.S. Food and Drug Administration (FDA) approval of an expansion to the labeled indication for ELEVIDYS to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. The FDA granted traditional approval for ambulatory patients and the FDA granted accelerated approval for non-ambulatory patients.

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