NDAORALTABLETPriority Review
Approved
Nov 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
PREVYMIS (letermovir) by Merck & Co. is dna terminase complex inhibitors [moa]. Approved for cytomegalovirus dna terminase complex inhibitor [epc]. First approved in 2017.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREVYMIS (letermovir) is an oral cytomegalovirus (CMV) DNA terminase complex inhibitor approved for CMV infection prophylaxis and treatment in immunocompromised patients, particularly hematopoietic stem cell transplant recipients. It works by inhibiting viral DNA packaging and replication, offering a novel mechanism distinct from traditional nucleoside analogues. The drug addresses a significant unmet need in preventing CMV disease, a serious complication in transplant populations.
LOE Approaching2.7 years to LOE
Product approaching loss of exclusivity (LOE) in 2.8 years with a $74M annual spending base; commercial teams should anticipate transition planning and potential downsizing.
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
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
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Started Apr 2024
80 enrolled
Cytomegalovirus InfectionsTransplant-Related Disorder
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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.