MedPath

Letermovir

Generic Name
Letermovir
Brand Names
Prevymis
Drug Type
Small Molecule
Chemical Formula
C29H28F4N4O4
CAS Number
917389-32-3
Unique Ingredient Identifier
1H09Y5WO1F
Background

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
Related News

A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus

Phase 1
Recruiting
Conditions
Congenital Cytomegalovirus Infection
Interventions
First Posted Date
2023-11-07
Last Posted Date
2025-05-16
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
12
Registration Number
NCT06118515
Locations
🇺🇸

Nationwide Children's Hospital-Neonatology-Center for Perinatal Research, Columbus, Ohio, United States

🇺🇸

Children's of Alabama Child Health Research Unit (CHRU), Birmingham, Alabama, United States

🇺🇸

Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease, Washington, District of Columbia, United States

and more 7 locations

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Phase 2
Recruiting
Conditions
Cytomegalovirus Infections
Transplant-Related Disorder
Interventions
First Posted Date
2023-10-04
Last Posted Date
2025-05-21
Lead Sponsor
University of Pennsylvania
Target Recruit Count
80
Registration Number
NCT06066957
Locations
🇺🇸

Penn Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

Phase 2
Not yet recruiting
Conditions
Infections, Cytomegalovirus
Interventions
First Posted Date
2023-09-28
Last Posted Date
2023-09-28
Lead Sponsor
Maimónides Biomedical Research Institute of Córdoba
Target Recruit Count
90
Registration Number
NCT06057194
Locations
🇪🇸

Hospital Universitario Reina Sofia, Cordoba, Córdoba, Spain

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

Phase 2
Recruiting
Conditions
CMV Infection
Hematopoietic Stem Cell Transplantation
Interventions
First Posted Date
2023-09-01
Last Posted Date
2023-09-01
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
80
Registration Number
NCT06021210
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

Phase 3
Recruiting
Conditions
Kidney Transplant; Complications
CMV
Interventions
Other: Historical/Control
First Posted Date
2023-08-21
Last Posted Date
2025-05-15
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
60
Registration Number
NCT06001320
Locations
🇺🇸

VCU Medical Center, Richmond, Virginia, United States

Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease

Phase 2
Not yet recruiting
Conditions
Graft-versus-host-disease
CMV
Interventions
First Posted Date
2023-08-01
Last Posted Date
2023-08-01
Lead Sponsor
Rabin Medical Center
Target Recruit Count
42
Registration Number
NCT05969743

Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT

Phase 4
Not yet recruiting
Conditions
The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation
Interventions
First Posted Date
2023-06-22
Last Posted Date
2023-06-22
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
21
Registration Number
NCT05914675

Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

Phase 4
Not yet recruiting
Conditions
To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation
Interventions
First Posted Date
2023-06-22
Last Posted Date
2023-06-22
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
31
Registration Number
NCT05914701

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

Completed
Conditions
Hematopoietic Stem Cell Transplantation
CMV Infection
Interventions
First Posted Date
2023-03-29
Last Posted Date
2025-02-19
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
200
Registration Number
NCT05789615
Locations
🇨🇳

The First Affiliated Hospital of Soochow university, Suzhou, Jiangsu, China

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)

Phase 3
Completed
Conditions
Cytomegalovirus Infection
Interventions
First Posted Date
2023-03-10
Last Posted Date
2025-03-25
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
120
Registration Number
NCT05763823
Locations
🇨🇳

Institute of hematology&blood disease hospital-Hematology ( Site 0030), Tianjin, Tianjin, China

🇨🇳

Shenzhen Second People's Hospital-Hematology Department ( Site 0006), Shenzhen, Guangdong, China

🇨🇳

The First Affiliated Hospital of Soochow University-hematology department ( Site 0029), Suzhou, Jiangsu, China

and more 18 locations
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