PREVYMIS (letermovir)
Prevymis (letermovir) is an antiviral indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) in adults and pediatric patients 6 months of age and older weighing at least 6 kg. It is also indicated for the prophylaxis of CMV disease in kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) in adults and pediatric patients 12 years of age and older weighing at least 40 kg.
How PREVYMIS Works
Letermovir is a CMV DNA terminase complex inhibitor. It functions by targeting the CMV DNA terminase complex (specifically subunits pUL51, pUL56, and pUL89), which is required for viral DNA processing and packaging. By inhibiting this complex, the drug prevents the cleavage of long-chain DNA concatemers into individual mature genomes, thereby blocking the production of infectious mature virions. Unlike many other CMV antivirals, its mechanism does not involve the inhibition of viral DNA polymerase.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-11-08
- Patent Cliff
- 2033
- Revenue
- $215M (Q4-2024)
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- SOLUTION, TABLET, PELLETS
PREVYMIS Approval History
What PREVYMIS Treats
2 indicationsPREVYMIS is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Infection
- Cytomegalovirus Disease
PREVYMIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PREVYMIS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07199465 | 8228-077 MK-8228-077 | Ph 1 | recruiting | A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077) |
| NCT07571135 | STUDY00000831 | Ph 4 | not yet recruiting | Letermovir vs Valganciclovir in CMV R+ Kidney Transplant |
| NCT06118515 | 21-0027 5U54AI150225-05 | Ph 1 | recruiting | A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus |
| NCT05711667 | ACCL1932 NCI-2022-10769, ACCL1932 | Ph 3 | recruiting | A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients |
| NCT05041426 results posted | STUDY21040074 | Ph 2 | completed | Letermovir for CMV Prevention After Lung Transplantation |
| NCT05446571 CYMEVAL3-step2 | APHP180592_step2 2020-002924-35 | Ph 3 | recruiting | Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir |
| NCT07020533 | 24168 NCI-2025-03633, 24168 | Ph 1 | recruiting | 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 |
| NCT07235683 CLEAR-CMV | 25-5760 | Ph 4 | recruiting | Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients |
| NCT06575374 | 2023-0828 NCI-2024-07402 | Ph 2 | recruiting | Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell |
| NCT06334497 LUCY-1 | APHP220791 2023-506216-40-00 | Ph 3 | recruiting | Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections |
| NCT06449586 | RJBMT-2024-02 | Ph 3 | active not recruiting | CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT |
| NCT07266467 CAPS01 | XJTUAF2025-CAPS01 | Ph 4 | recruiting | Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients |
| NCT06920251 OPTIMUS-EL | H-2503-044-1261 | Ph 2 | recruiting | Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy |
| NCT04060277 results posted | 19065 NCI-2019-04888, 19065 | Ph 2 | active not recruiting | Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation |
| NCT06407232 | 2024-0174 A561000, Protocol Version 8/22/25 | Ph 3 | recruiting | Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients |
| NCT07079735 VALET-CMV | AAAV8422 | Ph 2, Ph 3 | recruiting | Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant |
| NCT04904614 results posted | 00001538 | Ph 4 | completed | Letermovir Use in Heart Transplant Recipients |
| NCT06453460 | 4005 UCI 22-188 | Ph 2 | recruiting | CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT |
| NCT05626530 | 00003219 | Ph 4 | recruiting | Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients |
| NCT05763823 results posted | 8228-045 MK-8228-045 | Ph 3 | completed | A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045) |
| NCT04312841 results posted | OSU-19289 NCI-2020-00169 | Ph 2 | completed | Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab |
| NCT06626555 PROACTIV | 125096 2020-000288-22 | Ph 2 | not yet recruiting | Clinical Trial to Evaluate the Effects of Letermovir Prophylaxis on T-cell Immune Activation in Participants With Treated HIV-1 Infection |
| NCT03930615 results posted | 8228-040 MK-8228-040, 194797 | Ph 3 | completed | Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) |
| NCT03443869 results posted | 8228-002 MK-8228-002, 2017-001055-30 | Ph 3 | completed | Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) |
| NCT03728426 results posted | 18-348 | Ph 2 | completed | Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection |
| NCT02137772 results posted | 8228-001 2013-003831-31, 152923 | Ph 3 | completed | Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PREVYMIS FDA Label Details
Indications & Usage
FDA Label (PDF)PREVYMIS is indicated for the treatment of Cytomegalovirus Infection; Cytomegalovirus Disease.
PREVYMIS Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for PREVYMIS
Revenue Insights
- • Q4-2024: $215M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 16 active patents
Trial Analysis
- • 25 total trials
- • Stage: Expansion
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment