Drug Profile

Clesrovimab - Merck Sharp & Dohme

Alternative Names: Anti RSV F antibody - Merck Sharp & Dohme; clesrovimab-cfor - Merck Sharp & Dohme; ENFLONSIA; Enflonsia; MK-1654; Nfroncia

Latest Information Update: 12 Aug 2026

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At a glance

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

06 Aug 2026 Registered for Respiratory syncytial virus infections (Prevention, In infants, In neonates) in China (IM), prior to August 2026
06 Aug 2026 US FDA accepts sBLA for clesrovimab to update its Respiratory syncytial virus infections to include children under two years
31 Jul 2026 EMA accepts the application to expand marketing authorization for clesrovimab to update its Respiratory syncytial virus infections to include children under two years

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