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Clesrovimab FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 21, 2025.

FDA Approved: No
Generic name: clesrovimab
Company: Merck
Treatment for: RSV

Clesrovimab is an extended half-life monoclonal antibody in development as a passive immunization for the prevention of respiratory syncytial virus (RSV) disease in infants.

Development timeline for clesrovimab

DateArticle
Dec 17, 2024Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season
Oct 17, 2024Merck’s Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus (RSV) Preventative Monoclonal Antibody, Significantly Reduced Incidence of RSV Disease and Hospitalization in Healthy Preterm and Full-term Infants
Jul 23, 2024Merck Announces Topline Results from Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants

Further information

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