{"id":"letermovir-iv","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypokalemia"},{"rate":null,"effect":"Hypomagnesemia"}]},"_chembl":{"chemblId":"CHEMBL1241951","moleculeType":"Small molecule","molecularWeight":"572.56"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Letermovir is a first-in-class CMV terminase inhibitor that blocks the UL56 terminase protein, which is essential for packaging CMV DNA into virions. By inhibiting this viral enzyme, the drug prevents the formation of infectious CMV particles and reduces viral replication in infected cells. This mechanism is distinct from nucleoside analogs and allows for use in prophylaxis and treatment of CMV infection.","oneSentence":"Letermovir inhibits the viral terminase enzyme of cytomegalovirus (CMV), preventing viral DNA packaging and replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:18:33.541Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"CMV prophylaxis in CMV-seronegative recipients of allogeneic hematopoietic stem cell transplant from CMV-seropositive donors"},{"name":"CMV infection and disease in immunocompromised patients (treatment)"}]},"trialDetails":[{"nctId":"NCT07020533","phase":"PHASE1","title":"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","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2026-05-08","conditions":"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia","enrollment":46},{"nctId":"NCT05711667","phase":"PHASE3","title":"A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2024-07-11","conditions":"Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm","enrollment":105},{"nctId":"NCT04017962","phase":"PHASE2","title":"A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2019-07-19","conditions":"CMV, CMV Infection, Hematopoietic Cell Transplant","enrollment":102},{"nctId":"NCT05041426","phase":"PHASE2","title":"Letermovir for CMV Prevention After Lung Transplantation","status":"COMPLETED","sponsor":"Fernanda P Silveira, MD, MS","startDate":"2021-12-06","conditions":"Lung Transplant, CMV","enrollment":16},{"nctId":"NCT05763823","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-03-24","conditions":"Cytomegalovirus Infection","enrollment":120},{"nctId":"NCT04312841","phase":"PHASE2","title":"Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab","status":"COMPLETED","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2020-09-15","conditions":"B-Cell Prolymphocytic Leukemia, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma","enrollment":6},{"nctId":"NCT05789615","phase":"","title":"Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Soochow University","startDate":"2023-04-01","conditions":"CMV Infection, Hematopoietic Stem Cell Transplantation","enrollment":200},{"nctId":"NCT04129398","phase":"PHASE3","title":"MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-12-27","conditions":"Cytomegalovirus Infection, Cytomegalovirus Disease","enrollment":22},{"nctId":"NCT02137772","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-06-06","conditions":"Prevention of CMV Infection or Disease","enrollment":570}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["MK-8228","PREVYMIS®"],"phase":"phase_3","status":"active","brandName":"Letermovir IV","genericName":"Letermovir IV","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Letermovir inhibits the viral terminase enzyme of cytomegalovirus (CMV), preventing viral DNA packaging and replication. Used for CMV prophylaxis in CMV-seronegative recipients of allogeneic hematopoietic stem cell transplant from CMV-seropositive donors, CMV infection and disease in immunocompromised patients (treatment).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}