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Clesrovimab - Merck Sharp & Dohme

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Drug Profile

Clesrovimab - Merck Sharp & Dohme

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

Latest Information Update: 23 Sep 2025

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At a glance

  • Originator Merck Sharp & Dohme
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action Viral fusion protein inhibitors
  • 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

Highest Development Phases

  • Registered Respiratory syncytial virus infections

Most Recent Events

  • 19 Sep 2025 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends marketing authorization approval of clesrovimab for respiratory syncytial virus (RSV) (In infants, In neonates, Prevention) in European Union (EU), Iceland, Liechtenstein and Norway
  • 01 Aug 2025 Merck Sharp & Dohme completes a phase-III trial in Respiratory syncytial virus infections (In infants, In neonates, Prevention) in Finland, France, Hungary, Spain, Germany, Norway, Greece, Thailand, Turkey, United Kingdom, Peru, South Africa, Mexico, Malaysia, Japan, Italy, Colombia, Chile, Canada, Taiwan, Singapore, Puerto Rico, New Zealand, Hong Kong, Czech Republic, Australia and the US (IM) (NCT04938830) (EudraCT 2020-005996-11)
  • 01 Aug 2025 Preregistration for Respiratory syncytial virus infections (In infants, In neonates, Prevention) in Japan (IM)

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