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Drugs

Clesrovimab: First Approval

Published in:
Author
Yahiya Y. Syed
Published in
Drugs | Issue 11/2025

Abstract

Clesrovimab (ENFLONSIA™; clesrovimab-cfor) is a long-acting monoclonal antibody developed by Merck & Co., Inc. to prevent respiratory syncytial virus (RSV) disease in infants. It binds a highly conserved epitope at antigenic site IV of the RSV fusion protein, blocking viral entry into host cells and conferring passive immunity. Incorporation of a YTE triple amino acid substitution in the Fc region enhances binding to the neonatal Fc receptor, extending serum half-life and allowing a single, body weight-independent dose. Clesrovimab received its first US approval on 9 June 2025 for preventing RSV lower respiratory tract disease in neonates and infants born during, or entering, their first RSV season. This article summarises the milestones leading to this first approval.
Title
Clesrovimab: First Approval
Author
Yahiya Y. Syed
Publication date
04-09-2025
Publisher
Springer International Publishing
Published in
Drugs / Issue 11/2025
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-025-02224-7
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Keynote webinar | Spotlight on dry eye disease

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