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 Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

Phase 3
Active, not recruiting
Conditions
Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Interventions
Procedure: Biospecimen Collection
First Posted Date
2023-02-03
Last Posted Date
2025-03-19
Lead Sponsor
Children's Oncology Group
Target Recruit Count
143
Registration Number
NCT05711667
Locations
🇺🇸

UCSF Medical Center-Mission Bay, San Francisco, California, United States

🇺🇸

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 16 locations

Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies

Conditions
Hematopoietic Stem Cell Transplantation
CMV Infection
Interventions
First Posted Date
2022-12-19
Last Posted Date
2024-01-03
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
120
Registration Number
NCT05656599
Locations
🇨🇳

Department of Hematology, Peking University People's Hospital, Beijing, Beijing, China

🇨🇳

People's Hospital of Peking University, Beijing, China

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

Phase 4
Recruiting
Conditions
Antiviral Toxicity
Infection in Solid Organ Transplant Recipients
Cytomegalovirus Infections
Neutropenia
Interventions
First Posted Date
2022-11-23
Last Posted Date
2025-04-10
Lead Sponsor
Tufts Medical Center
Target Recruit Count
25
Registration Number
NCT05626530
Locations
🇺🇸

Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases, Boston, Massachusetts, United States

Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients

Phase 2
Recruiting
Conditions
CMV Viremia
Interventions
First Posted Date
2022-06-27
Last Posted Date
2023-11-09
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
90
Registration Number
NCT05432778
Locations
🇸🇮

University Medical Center Ljubljana, Ljubljana, Slovenia

Letermovir in ART-treated HIV-infected Persons

Not Applicable
Active, not recruiting
Conditions
People Living with HIV
Interventions
First Posted Date
2022-05-05
Last Posted Date
2024-11-20
Lead Sponsor
Jean-Pierre Routy
Target Recruit Count
60
Registration Number
NCT05362916
Locations
🇨🇦

Mcgill University Health Center, Montreal, Quebec, Canada

Letermovir for CMV Prevention After Lung Transplantation

Phase 2
Active, not recruiting
Conditions
Lung Transplant
CMV
Interventions
First Posted Date
2021-09-13
Last Posted Date
2025-03-25
Lead Sponsor
Fernanda P Silveira, MD, MS
Target Recruit Count
16
Registration Number
NCT05041426
Locations
🇺🇸

UPMC, Pittsburgh, Pennsylvania, United States

Letermovir Use in Heart Transplant Recipients

Phase 4
Completed
Conditions
Cytomegalovirus Disease
Cytomegalovirus Infections
Antiviral Toxicity
Neutropenia
Heart Transplant Infection
Interventions
First Posted Date
2021-05-27
Last Posted Date
2025-04-25
Lead Sponsor
Tufts Medical Center
Target Recruit Count
31
Registration Number
NCT04904614
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - STEP 1 (CYMEVAL3-STEP1)

Not Applicable
Completed
Conditions
TOP - Failed Attempted Termination of Pregnancy
Pregnant Women Undergoing TOP
Interventions
First Posted Date
2021-02-01
Last Posted Date
2022-03-15
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
7
Registration Number
NCT04732260
Locations
🇫🇷

Hôpital Necker - Enfants malades, Paris, France

Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab

Phase 2
Completed
Conditions
Chronic Lymphocytic Leukemia
Peripheral T-Cell Lymphoma
Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
T-Cell Prolymphocytic Leukemia
Sezary Syndrome
B-Cell Prolymphocytic Leukemia
Interventions
First Posted Date
2020-03-18
Last Posted Date
2025-02-28
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
6
Registration Number
NCT04312841
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

Phase 3
Completed
Conditions
Cytomegalovirus Infection
Cytomegalovirus Disease
Interventions
First Posted Date
2019-10-16
Last Posted Date
2024-08-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
22
Registration Number
NCT04129398
Locations
🇯🇵

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital ( Site 0002), Nagoya, Aichi, Japan

🇯🇵

Sapporo City General Hospital ( Site 0004), Sapporo, Hokkaido, Japan

🇯🇵

Osaka University Hospital ( Site 0003), Suita, Osaka, Japan

and more 1 locations
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