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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

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Trial Profile

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2026

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At a glance

  • Drugs Clesrovimab (Primary) ; Palivizumab
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Registrational
  • Acronyms SMART
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.; MSD KK

Most Recent Events

  • 06 Aug 2026 According to a Merck and Co media release,Based on data from this trial , In July 2026, the European Medicines Agency (EMA) accepted the application to expand marketing authorization for ENFLONSIA in the European Union (EU) for the same population.
  • 06 Aug 2026 According to a Merck and Co media release, Based on data from this trial ,the U.S. Food and Drug Administration has accepted a supplemental Biologics License Application for ENFLONSIA to expand its indication to prevention of respiratory syncytial virus lower respiratory tract disease (LRTD) in children under two years of age at increased risk for severe RSV disease through their second RSV season.The FDA has set a Prescription Drug User Fee Act (PDUFA) target action, date of March 22, 2027.
  • 04 Aug 2026 According to a Merck and Co media release, the company received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.

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