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Delandistrogene moxeparvovec - Roche/Sarepta Therapeutics

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Drug Profile

Delandistrogene moxeparvovec - Roche/Sarepta Therapeutics

Alternative Names: Delandistrogene moxeparvovec-rokl; Delandistrogenum moxeparvovecum - Roche/Sarepta Therapeutics; ELEVIDYS; rAAVrh74.MHCK7.micro-dystrophin; RG 6356; RO-7494222; SRP-9001

Latest Information Update: 14 Oct 2025

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At a glance

  • Originator Nationwide Children's Hospital
  • Developer Nationwide Children's Hospital; Roche; Sarepta Therapeutics
  • Class Gene therapies; Morpholines
  • Mechanism of Action Dystrophin replacements; Gene transference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Duchenne muscular dystrophy

Most Recent Events

  • 04 Sep 2025 Sarepta Therapeutics terminates the phase I HORIZON trial for Duchenne muscular dystrophy (In children) in USA (IV, Infusion) due to business decesion (NCT06597656)
  • 28 Jul 2025 US FDA recommends the removal of the voluntary hold for ambulatory patients for delandistrogene moxeparvovec for Duchenne Muscular Dystrophy
  • 25 Jul 2025 CHMP adopts negative opinion for approval of Delandistrogene moxeparvovec for Duchenne muscular dystrophy (In children) in European Union

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