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Delpacibart zotadirsen - Avidity Biosciences

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Drug Profile

Delpacibart zotadirsen - Avidity Biosciences

Alternative Names: AOC-1044; del-zota

Latest Information Update: 01 Dec 2025

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At a glance

  • Originator Avidity Biosciences
  • Class Drug conjugates; Immunoconjugates; Monoclonal antibodies; Oligonucleotides; Small interfering RNA
  • Mechanism of Action Dystrophin expression stimulants; RNA interference
  • 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 II Duchenne muscular dystrophy

Most Recent Events

  • 26 Nov 2025 Avidity Biosciences initiates an expanded access programme in Duchenne muscular dystrophy (In children, In adolescents, In adults) (IV-infusion) in USA (NCT07250737)
  • 13 Oct 2025 Avidity Biosciences plans to file BLA with the US FDA for Delpacibart zotadirsen in Duchenne muscular dystrophy in the first quarter of 2026 for accelerated approval
  • 13 Oct 2025 Avidity Biosciences completes pre-BLA meeting with the US FDA for Delpacibart zotadirsen in Duchenne muscular dystrophy

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