Delpacibart zotadirsen - Avidity Biosciences
Alternative Names: AOC-1044; del-zotaLatest Information Update: 16 Oct 2025
At a glance
- Originator Avidity Biosciences
- Class Drug conjugates; Immunoconjugates; Monoclonal antibodies; Oligonucleotides; Small interfering RNA
- Mechanism of Action Dystrophin expression stimulants; RNA interference
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Orphan Drug Status
Yes - Duchenne muscular dystrophy
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Duchenne muscular dystrophy
Most Recent Events
- 13 Oct 2025 Avidity Biosciences completes pre-BLA meeting with the US FDA for Delpacibart zotadirsen in Duchenne muscular dystrophy
- 13 Oct 2025 Avidity Biosciences plans to file BLA for Delpacibart zotadirsen in Duchenne muscular dystrophy in the first quarter of 2026
- 10 Sep 2025 Pooled efficacy and safety data from the phase I/II EXPLORE44® and EXPLORE44-OLE™ trials in Duchenne muscular dystrophy released by Avidity Biosciences