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DYNE 251

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Drug Profile

DYNE 251

Alternative Names: DYNE-251

Latest Information Update: 12 Aug 2025

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At a glance

  • Originator Dyne Therapeutics
  • Class Antibodies; Antisense oligonucleotides; Drug conjugates; Immunoconjugates
  • Mechanism of Action Dystrophin expression stimulants; Gene silencing
  • 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 Yes

Highest Development Phases

  • Phase I/II Duchenne muscular dystrophy

Most Recent Events

  • 04 Aug 2025 DYNE 251 receives Breakthrough Therapy status for Duchenne muscular dystrophy in USA
  • 04 Aug 2025 Dyne Therapeutics continues to pursue approval pathways outside of the USA for DYNE 251 in patients with Duchenne muscular dystrophy with a confirmed mutation amenable to exon 51 skipping
  • 28 Jul 2025 Dyne Therapeutics completes enrolment in its phase I/II DELIVER trials in Duchenne muscular dystrophy (In children, In adolescents) in USA, Australia, South Korea, Ireland, Belgium, Canada, Spain, and United Kingdom (IV) (NCT05524883) (EudraCT2021-005478-24)

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