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Prevymis (LETERMOVIR)
Prevymis works by inhibiting the DNA terminase complex of the cytomegalovirus, preventing the virus from replicating.
At a glance
| Generic name | LETERMOVIR |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Cytomegalovirus DNA Terminase Complex Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 978 |
Mechanism of action
PREVYMIS is an antiviral drug against CMV [see Microbiology (12.4)].
Approved indications
- Cytomegalovirus infection
Common side effects
- nausea
- diarrhea
- vomiting
- peripheral edema
- cough
- headache
- fatigue
- abdominal pain
- tachycardia
- atrial fibrillation
- hypersensitivity reaction
- dyspnea
Key clinical trials
- A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus (PHASE1)
- A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant (PHASE1)
- Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis (NA)
- A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077) (PHASE1)
- Reducing Post-Letermovir CMV Infection: Efficacy of an Immune-Reconstitution-Based Scoring System to Guide Prophylaxis Duration
- A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients (PHASE3)
- Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients (PHASE4)
- Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10603384 | 2033-02-28 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prevymis CI brief — competitive landscape report
- Prevymis updates RSS · CI watch RSS
- Merck & Co. portfolio CI