NDAORALPELLETSPriority Review
Approved
Aug 2024
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
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 17h 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 approved by the FDA on August 30, 2024, for the treatment of cytomegalovirus (CMV) infection. It works by blocking CMV DNA replication at the terminase complex, preventing viral DNA packaging and spread. This mechanism offers a novel approach to CMV prophylaxis and treatment in immunocompromised patients.
$74MPart D
LOE Approaching2.3 years to LOEProduct is in late-stage commercial maturity with patent expiration approaching in 2029, signaling a need for brand defense strategies and potential team restructuring.
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)
Letermovir for R+ Study
Started Sep 2026
146 enrolled
Kidney TransplantLiver Transplant
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
3 enrolled
Congenital Cytomegalovirus Infection
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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.