Drug

Letermovir

Approved · EMA

Emerging researchLate-stage development

Also known as Prevymis.

RxNorm1988648 ChEMBLCHEMBL1241951UNII1H09Y5WO1F

Research papers

Active clinical trials

Regulatory events

Latest activity

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Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase I Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Disease

Clinical trial2026-08-03Status changed to Completed · ClinicalTrials.gov

Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant

Clinical trial2026-07-08Results expected Q2 2028 · ClinicalTrials.gov

The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients

Clinical trial2026-06-15Results expected Q3 2027 · ClinicalTrials.gov

A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Clinical trial2026-06-12Results expected Q2 2028 · ClinicalTrials.gov

An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients

Clinical trial2026-06-11Results expected Q3 2027 · ClinicalTrials.gov

Open Label Trial of Tolerability and Efficacy of Oral Letermovir for CMV Prophylaxis Among Heart and Lung Transplant Recipients

Clinical trial2026-06-03Results expected Q3 2026 · ClinicalTrials.gov

Letermovir safety and efficacy for cytomegalovirus prophylaxis in adult Japanese kidney transplant recipients: a multicenter, open-label, noncomparative Phase 3 study.

Research2024-04-13Clinical and experimental nephrology

Pharmacokinetics, Safety, and Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Adolescent Hematopoietic Cell Transplantation Recipients.

Research2024-01-19The Pediatric infectious disease journal

Efficacy and safety of extended duration letermovir prophylaxis in recipients of haematopoietic stem-cell transplantation at risk of cytomegalovirus infection: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Research2023-12-21The Lancet. Haematology

Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial.

Research2023-07-01JAMA

Approval: Prevymis (EMA)

Regulatory2018-01-08EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Letermovir

Aliases & brands

Prevymis

RxNorm CUI

1988648

ChEMBL ID

CHEMBL1241951

UNII

1H09Y5WO1F

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-01-08

Latest approval

2018-01-08

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-01-08Approval

Approval: Prevymis (EMA)

Indication: Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients… Show full indication

Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents. 

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.