Letermovir

Generic Name: Letermovir

Brand Names: Prevymis

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₈F_₄N_₄O_₄

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

Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation

Phase 2

Active, not recruiting

Conditions: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Lymphoblastic Lymphoma
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Hematopoietic and Lymphoid Cell Neoplasm
Hodgkin Lymphoma
Myelofibrosis

Interventions: Drug: Letermovir
Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Other: Placebo Administration

First Posted Date: 2019-08-19

Last Posted Date: 2024-10-30

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 7

Registration Number: NCT04060277

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

Phase 2

Active, not recruiting

Conditions: CMV
CMV Infection
Hematopoietic Cell Transplant

Interventions: Drug: Letermovir Pill
Other: blood draw

First Posted Date: 2019-07-12

Last Posted Date: 2024-08-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 102

Registration Number: NCT04017962

Locations: 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

Phase 2

Completed

Conditions: Cytomegalovirus (CMV) Infection

Interventions: Drug: Letermovir oral granules
Drug: Letermovir tablet
Drug: Letermovir intravenous

First Posted Date: 2019-05-07

Last Posted Date: 2024-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 65

Registration Number: NCT03940586

Locations: 🇺🇸
Seattle Childrens Hospital ( Site 0248), Seattle, Washington, United States
🇺🇸
UCSF Benioff Children's Hospital San Francisco ( Site 0245), San Francisco, California, United States
🇮🇱
Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123), Ramat Gan, Israel

and more 37 locations

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)

Phase 3

Completed

Conditions: Cytomegalovirus Infection

Interventions: Drug: Letermovir
Drug: Placebo

First Posted Date: 2019-04-29

Last Posted Date: 2024-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 220

Registration Number: NCT03930615

Locations: 🇺🇸
Indiana Blood and Marrow Transplantation ( Site 0175), Indianapolis, Indiana, United States
🇺🇸
The University of Texas MD Anderson Cancer Center ( Site 0154), Houston, Texas, United States
🇫🇷
Centre Hospitalier Universitaire Dupuytren ( Site 0182), Limoges, Haute-Vienne, France

and more 29 locations

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

Phase 2

Completed

Conditions: Cytomegalovirus Infections

Interventions: Drug: Letermovir

First Posted Date: 2018-11-02

Last Posted Date: 2023-03-08

Lead Sponsor: Amy C. Sherman, MD

Target Recruit Count: 10

Registration Number: NCT03728426

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States

and more 1 locations

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Phase 3

Completed

Conditions: CMV Disease

Interventions: Drug: Letermovir
Drug: Valganciclovir
Drug: Acyclovir (ACV)
Drug: Placebo to ACV
Drug: Placebo to LET
Drug: Placebo to VGCV

First Posted Date: 2018-02-23

Last Posted Date: 2023-07-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 601

Registration Number: NCT03443869

Locations: 🇺🇸
University of Chicago ( Site 0251), Chicago, Illinois, United States
🇺🇸
Brigham & Women's Hospital ( Site 0244), Boston, Massachusetts, United States
🇺🇸
The Ohio State University Wexner Medical Center ( Site 0264), Columbus, Ohio, United States

and more 91 locations

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)

Phase 3

Completed

Conditions: Prevention of CMV Infection or Disease

Interventions: Drug: Placebo
Drug: Letermovir

First Posted Date: 2014-05-14

Last Posted Date: 2019-09-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 570

Registration Number: NCT02137772

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