Enflonsia clesrovimab APPROVED
Drug Profile
ModalityMonoclonal antibody
RouteIM
Therapy AreaInfectious Disease
Launch2025-06-01
Peak Sales Est$3000M
Formulations[{"id":"enfl-im","doses":"Fixed dose (not weight-based)","route":"IM","device":"Pre-filled syringe (
Companies
MRK (ORIGINATOR)100%
Mechanism: Anti-RSV F protein monoclonal antibody
Expert: Monoclonal antibody targeting the prefusion conformation of the RSV F (fusion) glycoprotein. Prevents viral attachment and membrane fusion with respiratory epithelial cells. Extended half-life achieved through Fc modifications (YTE mutations in nirsevimab; similar approach in clesrovimab) enabling single-dose seasonal protection.
Everyday: RSV (respiratory syncytial virus) uses a protein on its surface called F protein to fuse with and enter human lung cells. These antibodies stick to the F protein like a cap, blocking the virus from getting inside cells. A single injection provides protection for an entire RSV season.
Targets: []
Programs (1)
IndicationStageKey StudyRegional Status
RSV prevention (infants)APPROVEDPivotal Phase 3[{"stage":"APPROVED","region":"US","approval_date":"2025-06-01"}]
Notes
Merck anti-RSV mAb. FDA approved June 2025. First direct competitor to Beyfortus. Key advantage: single fixed-dose prefilled syringe (vs Beyfortus weight-based dosing). 84% reduction in RSV hospitalization. Key threat to Beyfortus market share. Simpler dosing could drive formulary preference.
Data from Supabase · Updated 2026-03-24