Letermovir

Overview

Letermovir recieved approval from the FDA on November 8th, 2017 for use in prophylaxis of cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients. It is the first of a new class of CMV anti-infectives called DNA terminase complex inhibitors. Letermovir has recieved both priority and orphan drug status from the FDA. It is currently marketed under the brand name Prevymis.

Indication

Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).

Associated Conditions

Cytomegalovirus (CMV) Infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis	2025/08/03	NCT07101055	Not Applicable	Not yet recruiting	Jason A Roberts
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant	2025/07/23	NCT07079735	Not Applicable	Recruiting	Columbia University
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	2025/06/13	NCT07020533	Phase 1	Not yet recruiting	City of Hope Medical Center
Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy	2025/04/09	NCT06920251	Phase 2	Not yet recruiting	Seoul National University Hospital
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients	2024/10/15	NCT06639854	Not Applicable	Recruiting	M.D. Anderson Cancer Center
Clinical Trial to Evaluate the Effects of Letermovir Prophylaxis on T-cell Immune Activation in Participants With Treated HIV-1 Infection	2024/10/04	NCT06626555	Phase 2	Not yet recruiting	University College, London
Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell	2024/08/28	NCT06575374	Phase 2	Recruiting	M.D. Anderson Cancer Center
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT	2024/06/11	NCT06453460	Phase 2	Recruiting	University of California, Irvine
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT	2024/06/10	NCT06449586	Not Applicable	Recruiting	Ruijin Hospital
Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT	2024/06/04	NCT06441669	N/A	Recruiting	Anhui Provincial Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PREVYMIS	Merck Sharp & Dohme LLC	0006-3075	ORAL	240 mg in 1 1	8/2/2023
PREVYMIS	Merck Sharp & Dohme LLC	0006-5004	INTRAVENOUS	20 mg in 1 mL	8/2/2023
PREVYMIS	Merck Sharp & Dohme LLC	0006-5003	INTRAVENOUS	20 mg in 1 mL	8/2/2023
PREVYMIS	Merck Sharp & Dohme LLC	0006-3076	ORAL	480 mg in 1 1	8/2/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Prevymis	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	1/8/2018
Prevymis	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	1/8/2018

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML	MSD International GmbH T/A MSD Ireland (Carlow)	SIN15759P	INFUSION, SOLUTION CONCENTRATE	20mg/ml	7/30/2019
PREVYMIS FILM COATED TABLET 480MG	MSD International GmbH T/A MSD Ireland (Ballydine), Organon Heist bv (Primary Packager and Secondary packager)	SIN15758P	TABLET, FILM COATED	480.0mg	7/30/2019
PREVYMIS FILM COATED TABLET 240MG	MSD International GmbH T/A MSD Ireland (Ballydine), Organon Heist bv (Primary Packager and Secondary packager)	SIN15757P	TABLET, FILM COATED	240.0mg	7/30/2019

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/12ML	N/A	MERCK SHARP & DOHME (ASIA) LIMITED	N/A	N/A	2/27/2019

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PREVYMIS letermovir 480 mg film-coated tablet blister pack	289797	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	6/22/2018
PREVYMIS letermovir 480 mg/24 mL concentrated injection for infusion vial	289796	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	6/22/2018
PREVYMIS letermovir 240 mg film-coated tablet blister pack	289795	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	6/22/2018
PREVYMIS letermovir 240 mg/12 mL concentrated injection for infusion vial	289794	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	6/22/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PREVYMIS	Merck Canada Inc	02469367	Solution - Intravenous	20 MG / ML	12/20/2017
PREVYMIS	Merck Canada Inc	02469383	Tablet - Oral	480 MG	12/20/2017
PREVYMIS	Merck Canada Inc	02469375	Tablet - Oral	240 MG	12/20/2017
PREVYMIS	Merck Canada Inc	02469405	Solution - Intravenous	20 MG / ML	12/20/2017

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PREVYMIS 240 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Merck Sharp & Dohme B.V.	1171245001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
PREVYMIS 480 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Merck Sharp & Dohme B.V.	1171245002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
PREVYMIS 480 MG CONCENTRADO PARA SOLUCION PARA PERFUSION	Merck Sharp & Dohme B.V.	1171245004	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
PREVYMIS 240 MG CONCENTRADO PARA SOLUCION PARA PERFUSION	Merck Sharp & Dohme B.V.	1171245003	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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