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Drugs

Donidalorsen: First Approval

Published in:
Author
Yahiya Y. Syed
Published in
Drugs | Issue 2/2026

Abstract

Donidalorsen (DAWNZERA™) is a first-in-class, RNA-targeted antisense oligonucleotide (ASO), developed by Ionis Pharmaceuticals for the prevention of hereditary angioedema (HAE) attacks. It received its first approval on 21 August 2025 in the USA for the prophylaxis of HAE attacks in adult and paediatric patients aged 12 years and older. Donidalorsen is currently under regulatory review in the EU and in phase III development in several other countries. This article summarizes the key milestones in the development of donidalorsen leading to its first approval for HAE.
Title
Donidalorsen: First Approval
Author
Yahiya Y. Syed
Publication date
12-11-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 2/2026
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02257-y
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