NDAORALPELLETSPriority Review
Approved
Aug 2024
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
PREVYMIS (letermovir) by Merck & Co. is dna terminase complex inhibitors [moa]. Approved for cytomegalovirus dna terminase complex inhibitor [epc]. First approved in 2024.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREVYMIS (letermovir) is an oral small-molecule DNA terminase complex inhibitor developed by Merck & Co. for cytomegalovirus (CMV) prophylaxis, primarily in immunocompromised populations such as hematopoietic stem cell transplant recipients. It functions by blocking CMV viral DNA processing and packaging, reducing the risk of CMV disease in at-risk patients.
$0.074BPart D
LOE Approaching2.6 years to LOEProduct approaching loss of exclusivity with moderate Part D claims volume; commercial teams should prioritize retention and lifecycle extension strategies.
Mechanism of Action
DNA Terminase Complex Inhibitors
Pharmacologic Class:
Cytomegalovirus DNA Terminase Complex Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Started Mar 2026
40 enrolled
Cytomegalovirus Prophylaxis
Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
Started Oct 2025
120 enrolled
Cytomegalovirus InfectionsCytomegalovirus DiseaseHematopoietic Stem Cell Transplantation+1 more
Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis
Started Sep 2025
20 enrolled
End-Stage Kidney Disease (ESKD)
A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus
Started Feb 2025
12 enrolled
Congenital Cytomegalovirus Infection
Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
Started Aug 2024
90 enrolled
Cytomegalovirus InfectionsKidney Transplant InfectionPancreas Transplant
Worked on PREVYMIS at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.