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 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREVYMIS (letermovir) is an oral small-molecule cytomegalovirus (CMV) DNA terminase complex inhibitor developed by Merck & Co. and approved on August 30, 2024. It is indicated for CMV prophylaxis in high-risk transplant recipients. The drug works by inhibiting the CMV DNA terminase complex, a mechanism distinct from existing antivirals, offering a novel approach to preventing CMV infection in immunocompromised populations.
$0.1BPart D
2.7 years to LOEMechanism 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.