Drugs / Letermovir
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Letermovir

also known as PREVYMIS · AIC246 · LET · Letermovir Tablets · LTM · LTV · MK-8228

Small molecule

Developed for
cytomegalovirus infection · disease related to solid organ transplantation · HIV infectious disease · disease related to transplantation · fetal cytomegalovirus syndrome · idiopathic disseminated cytomegalovirus infection
Investigated by
Merck Sharp & Dohme LLC · Assistance Publique - Hôpitaux de Paris · URC-CIC Paris Descartes Necker Cochin · Institute of Hematology & Blood Diseases Hospital, China · M.D. Anderson Cancer Center · National Institute of Allergy and Infectious Diseases (NIAID)
+33 more · The First Affiliated Hospital of Soochow University · Tufts Medical Center · University of Wisconsin, Madison · AiCuris Anti-infective Cures AG · Amy C. Sherman, MD · Beijing Children's Hospital · Children's Oncology Group · City of Hope Medical Center · Columbia University · Cornell University · Eurofins Viracor · Fernanda P Silveira, MD, MS · Hospital do Rim e Hipertensão · Jason A Roberts · Jean-Pierre Routy · MERCK SHARP & DOHME DE ESPAÑA S.A. · Maimónides Biomedical Research Institute of Córdoba · Memorial Sloan Kettering Cancer Center · National Cancer Institute (NCI) · Ohio State University Comprehensive Cancer Center · Quintiles, Inc. · Rabin Medical Center · Royal Brisbane and Women's Hospital · Royal Free Hospital NHS Foundation Trust · Ruijin Hospital · Seoul National University Hospital · University College, London · University Health Network, Toronto · University Medical Centre Ljubljana · University of California, Irvine · University of Pennsylvania · Virginia Commonwealth University · WeiShi

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) PREVYMIS 2023-06-05 – 2024-08-30 fda.gov
Approved EU (EMA) Prevymis 2018-01-08 europa.eu
Approved US (FDA) PREVYMIS 2017-11-08 fda.gov

Trials 45 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07020533 May 2026 → May 2028 expected Hodgkins lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, leukemia, myeloid, accelerated-phase +3 City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT07199465 Mar 2026 → Apr 2028 expected cytomegalovirus infection Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1 NCT07101055 Sep 2025 → Feb 2027 expected end stage renal failure Jason A Roberts Not yet recruiting No outcome recorded
Phase 1 NCT06118515 Feb 2025 → May 2026 cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 216 trials
Phase 2 NCT06920251 Sep 2025 → Dec 2027 expected refractory plasma cell neoplasm Seoul National University Hospital Recruiting No outcome recorded
Phase 2 NCT06575374 Dec 2024 → Aug 2026 overdue M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06626555 Oct 2024 → Mar 2026 overdue HIV infectious disease University College, London Not yet recruiting No outcome recorded
Phase 2 NCT06453460 Jun 2024 → Jun 2028 expected cytomegalovirus infection, disease related to hematopoietic stem cell transplant University of California, Irvine Recruiting No outcome recorded
Phase 2 NCT06066957 Apr 2024 → Aug 2026 overdue cytomegalovirus infection, disease related to transplantation University of Pennsylvania Recruiting No outcome recorded
Phase 2 NCT05969743 Oct 2023 → Apr 2025 cytomegalovirus infection, graft versus host disease Rabin Medical Center Unknown No outcome recorded
Phase 2 NCT06057194 Oct 2023 → Apr 2027 expected cytomegalovirus infection Maimónides Biomedical Research Institute of Córdoba Not yet recruiting No outcome recorded
Phase 2 NCT05432778 May 2023 → Aug 2025 overdue cytomegalovirus infection University Medical Centre Ljubljana Recruiting No outcome recorded
Phase 2 NCT06021210 Jul 2022 → Jul 2024 cytomegalovirus infection The First Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 2 NCT04840199 Apr 2022 → Nov 2023 HIV infectious disease, cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07079735 Sep 2025 → Jan 2028 expected cytomegalovirus infection, disease related to solid organ transplantation, transplant rejection Columbia University Recruiting No outcome recorded
Phase 312 trials
Phase 3 NCT06334497 Aug 2024 → Sep 2027 expected cytomegalovirus infection Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT06407232 Aug 2024 → Aug 2027 expected cytomegalovirus infection, disease related to solid organ transplantation University of Wisconsin, Madison Recruiting No outcome recorded
Phase 3 NCT05711667 Jul 2024 → Jun 2029 expected cancer, hematopoietic and lymphoid cell neoplasm Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT06449586 Jul 2024 → Jun 2026 overdue hematopoietic and lymphoid system neoplasm Ruijin Hospital Active not recruiting No outcome recorded
Phase 3 NCT06341686 May 2024 → Mar 2025 cytomegalovirus infection Hospital do Rim e Hipertensão Unknown No outcome recorded
Phase 3 NCT05446571 Oct 2023 → Aug 2029 expected fetal cytomegalovirus syndrome Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT06001320 Sep 2023 → Sep 2026 expected cytomegalovirus infection Virginia Commonwealth University Active not recruiting No outcome recorded
Phase 3 NCT05763823 Mar 2023 → Apr 2024 cytomegalovirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT04129398 Dec 2019 → Oct 2022 cytomegalovirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT03930615 Jun 2019 → Oct 2021 cytomegalovirus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 47 trials
Phase 4 NCT07706166 Aug 2026 → Aug 2029 expected University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 4 NCT07235683 Dec 2025 → Aug 2027 expected cytomegalovirus infection University Health Network, Toronto Recruiting No outcome recorded
Phase 4 NCT07569653 Oct 2025 → Oct 2027 expected cytomegalovirus infection, graft versus host disease WeiShi Recruiting No outcome recorded
Phase 4 NCT05914675 Jul 2023 → Dec 2024 Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
Phase 4 NCT05914701 Jul 2023 → Dec 2024 Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
Phase 4 NCT05626530 Feb 2023 → Dec 2025 overdue cytomegalovirus infection, disease related to solid organ transplantation, neutropenia, poisoning Tufts Medical Center Recruiting No outcome recorded
Phase 4 NCT04904614 Jan 2022 → Jan 2025 cytomegalovirus infection, disease related to solid organ transplantation, neutropenia, poisoning Tufts Medical Center Completed No outcome recorded
Phase not applicable5 trials
NCT07488728 Oct 2025 → Dec 2026 expected Epstein-Barr virus-associated lymphoproliferative disorder, secondary hemophagocytic lymphohistiocytosis Beijing Children's Hospital Recruiting No outcome recorded
NCT06812598 Dec 2024 → Jun 2026 overdue cytomegalovirus infection The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
NCT06639854 Nov 2024 → Jul 2027 expected cytomegalovirus infection, disease related to hematopoietic stem cell transplant M.D. Anderson Cancer Center Recruiting No outcome recorded
NCT05362916 Sep 2022 → Jan 2025 Jean-Pierre Routy Completed No outcome recorded
NCT04732260 Jun → Nov 2021 Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT04060277 Background Nov 2019 → Jun 2023 overdue Hodgkins lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, leukemia, myeloid, accelerated-phase +3 City of Hope Medical Center Active not recruiting No outcome recorded
Phase 42 trials
Phase 4 NCT07571135 Comparator May 2026 → Nov 2028 expected cytomegalovirus infection Elisabeth Kincaide Not yet recruiting No outcome recorded
Phase 4 NCT07266467 Comparator May 2025 → Nov 2026 expected First Affiliated Hospital Xi'an Jiaotong University Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 50 sources stand behind the page.

FieldValueCited text
Known as Letermovir “A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention...” NCT03443869
47

“Patients received oral letermovir (at a dose of 60, 120, or 240 mg per day, or matching placebo) for 12 weeks after engraftment.” PMID 24806159 May 2014

NCT07020533

NCT05626530

NCT05446571

NCT04312841

NCT06575374

NCT06626555

NCT05969743

NCT07266467

NCT03728426

NCT04017962

NCT04129398

NCT05763823

NCT07706166

NCT06118515

NCT06407232

NCT05041426

NCT03940586

NCT07569653

NCT06066957

NCT06341686

NCT07488728

NCT06334497

NCT05362916

NCT02137772

NCT05914675

NCT05914701

NCT06920251

NCT06021210

NCT06057194

NCT06812598

NCT04840199

NCT06001320

NCT04904614

NCT07199465

NCT05711667

NCT07571135

NCT05432778

NCT07235683

NCT06449586

NCT07079735

NCT04060277

NCT07101055

NCT06639854

NCT03930615

NCT04732260

NCT06453460

Known as AIC246 “we evaluated the effect of letermovir (also known as AIC246), a new anti-CMV drug with a novel mechanism of action” PMID 24806159 May 2014
Known as LET “This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of...” NCT05626530
Known as Letermovir Tablets Letermovir TabletsNCT06021210
Known as LTM “Letermovir (LTM) is a new anti CMV drug, manufactured by Merck that:” NCT04732260
Known as LTV “Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT.” NCT06449586
Known as MK-8228 “A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention...” NCT03443869
Known as PREVYMIS “Letermovir 480 mg [PREVYMIS]” NCT07101055
1

“Letermovir 480 MG [Prevymis]” NCT06066957

Action Inhibit “Letermovir is an antiviral drug that inhibits the CMV-terminase complex.” PMID 29211658 Dec 2017
Modality Small molecule CHEMBL1241951
Route Oral “Patients received oral letermovir (at a dose of 60, 120, or 240 mg per day, or matching placebo) for 12 weeks after engraftment.” PMID 24806159 May 2014