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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-251 Administered to Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-251 Administered to Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Oct 2025

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At a glance

  • Drugs DYNE-251 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DELIVER
  • Sponsors Dyne Therapeutics

Most Recent Events

  • 04 Aug 2025 According to a Dyne Therapeutics media release, the company announced that the FDA has granted Breakthrough Therapy Designation to DYNE-251 for the treatment of patients with Duchenne muscular dystrophy. The designation is based on data from this study and this designation offers Rolling and Priority Review eligibility, potentially reducing the Biologics License Application (BLA) review timeline from 12 to 8 months.
  • 04 Aug 2025 According to a Dyne Therapeutics media release, data from the DELIVER registrational expansion cohort is expected in late 2025, with a potential BLA submission for U.S. accelerated approval anticipated in early 2026.
  • 28 May 2025 Status changed from recruiting to active, no longer recruiting.

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