Letermovir (AIC246) Clinical Trials

Size	Price	Qty
2mg	USD 157
5mg	USD 297

Clinical Trials

Numerous clinical trials evaluate letermovir across diverse populations affected by cytomegalovirus (CMV) infections, including solid organ and stem cell transplant recipients, pregnant women, and pediatric and adult patients. Ranging from Early Phase 1 through Phase 4, these studies span recruitment statuses from not yet recruiting to completed and terminated. Sponsored by pharmaceutical companies, academic institutions, and government agencies, these trials evaluate prophylaxis, therapeutic efficacy, safety, and pharmacokinetics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07706166	NOT_YET_RECRUITING	Kidney Transplant; Liver Transplant	University of Wisconsin, Madison	2026-09	PHASE4
NCT05446571	RECRUITING	Pregnant Women; CMV Infected Fetuses	Assistance Publique - Hôpitaux de Paris	2023-10-20	PHASE3
NCT05711667	RECRUITING	Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm	Children's Oncology Group	2024-07-11	PHASE3
NCT07571135	NOT_YET_RECRUITING	CMV Infection; CMV; CMV Viremia; CMV Disease	Elisabeth Kincaide	2026-05	PHASE4
NCT06575374	RECRUITING	Cell Therapy	M.D. Anderson Cancer Center	2024-12-12	PHASE2
NCT06453460	RECRUITING	CMV; Allogeneic Stem Cell Transplantation	University of California, Irvine	2024-06-27	PHASE2
NCT07020533	RECRUITING	Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia; Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphatic System Neoplasm; Hodgkin Lymphoma; Lymphoblastic Lymphoma; Myelodysplastic Syndrome; Myelofibrosis; Myeloproliferative Neoplasm; Non-Hodgkin Lymphoma	City of Hope Medical Center	2026-05-08	PHASE1
NCT07199465	RECRUITING	Cytomegalovirus Prophylaxis	Merck Sharp & Dohme LLC	2026-03-30	PHASE1
NCT07079735	RECRUITING	CMV Viremia; Heart Transplant Infection; Heart Transplant Failure and Rejection	Columbia University	2025-09-12	PHASE2; PHASE3
NCT06920251	RECRUITING	Relapsed Refractory Multiple Myeloma (RRMM)	Seoul National University Hospital	2025-09-11	PHASE2
NCT07569653	RECRUITING	Cytomegalovirus Infections; Cytomegalovirus Disease; Hematopoietic Stem Cell Transplantation; Graft vs Host Disease	WeiShi	2025-10-30	PHASE4
NCT06334497	RECRUITING	Cytomegalovirus Infection	Assistance Publique - Hôpitaux de Paris	2024-08-14	PHASE3
NCT06407232	RECRUITING	Cytomegalovirus Infections; Kidney Transplant Infection; Pancreas Transplant	University of Wisconsin, Madison	2024-08-08	PHASE3
NCT07235683	RECRUITING	CMV; Lung Transplant Recipient	University Health Network, Toronto	2025-12-24	PHASE4
NCT06639854	RECRUITING	Cytomegalovirus Cell Mediated Immunity; Hematopoietic Cell Transplant	M.D. Anderson Cancer Center	2024-11-20
NCT06057194	NOT_YET_RECRUITING	Infections, Cytomegalovirus	Maimónides Biomedical Research Institute of Córdoba	2023-10	PHASE2
NCT07101055	NOT_YET_RECRUITING	End-Stage Kidney Disease (ESKD)	Jason A Roberts	2025-09	PHASE1
NCT07488728	RECRUITING	EBV-associated T/NK-cell Lymphoproliferative Diseases; Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis; Letermovir	Beijing Children's Hospital	2025-10-01
NCT07266467	RECRUITING	Kidney Transplant	First Affiliated Hospital Xi'an Jiaotong University	2025-05-13	PHASE4
NCT06001320	ACTIVE_NOT_RECRUITING	Kidney Transplant; Complications; CMV	Virginia Commonwealth University	2023-09-25	PHASE3
NCT06066957	RECRUITING	Cytomegalovirus Infections; Transplant-Related Disorder	University of Pennsylvania	2024-04-04	PHASE2
NCT06449586	ACTIVE_NOT_RECRUITING	Hematologic Malignancy	Ruijin Hospital	2024-07-01	PHASE3
NCT06812598	RECRUITING	Cytomegalovirus Infections; CMV	The First Affiliated Hospital of Soochow University	2024-12-16
NCT06118515	COMPLETED	Congenital Cytomegalovirus Infection	National Institute of Allergy and Infectious Diseases (NIAID)	2025-02-19	PHASE1
NCT06626555	NOT_YET_RECRUITING	HIV	University College, London	2024-10	PHASE2
NCT05626530	RECRUITING	Cytomegalovirus Infections; Infection in Solid Organ Transplant Recipients; Neutropenia; Antiviral Toxicity	Tufts Medical Center	2023-02-02	PHASE4
NCT05432778	UNKNOWN	CMV Viremia	University Medical Centre Ljubljana	2023-05-01	PHASE2
NCT06339892	UNKNOWN	Cytomegalovirus Infections; Cytomegalovirus Viremia; Hematopoietic Stem Cell Transplantation	Fondazione IRCCS Policlinico San Matteo di Pavia	2023-01-09
NCT05969743	UNKNOWN	Graft-versus-host-disease; CMV	Rabin Medical Center	2023-10-01	PHASE2
NCT05041426	COMPLETED	Lung Transplant; CMV	Fernanda P Silveira, MD, MS	2021-12-06	PHASE2
NCT06341686	UNKNOWN	CMV Infection	Hospital do Rim e Hipertensão	2024-05-05	PHASE3
NCT05362916	COMPLETED	People Living With HIV	Jean-Pierre Routy	2022-09-26
NCT04904614	COMPLETED	Cytomegalovirus Disease; Cytomegalovirus Infections; Heart Transplant Infection; Antiviral Toxicity; Neutropenia	Tufts Medical Center	2022-01-05	PHASE4
NCT05914701	UNKNOWN	To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation	Institute of Hematology & Blood Diseases Hospital, China	2023-07-01	PHASE4
NCT05914675	UNKNOWN	The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation	Institute of Hematology & Blood Diseases Hospital, China	2023-07-01	PHASE4
NCT04017962	COMPLETED	CMV; CMV Infection; Hematopoietic Cell Transplant	Memorial Sloan Kettering Cancer Center	2019-07-19	PHASE2
NCT06021210	UNKNOWN	CMV Infection; Hematopoietic Stem Cell Transplantation	The First Affiliated Hospital of Soochow University	2022-07-07	PHASE2
NCT05763823	COMPLETED	Cytomegalovirus Infection	Merck Sharp & Dohme LLC	2023-03-24	PHASE3
NCT04840199	TERMINATED	HIV Infections; Cytomegalovirus; CMV	National Institute of Allergy and Infectious Diseases (NIAID)	2022-04-19	PHASE2
NCT04312841	COMPLETED	B-Cell Prolymphocytic Leukemia; Chronic Lymphocytic Leukemia; Peripheral T-Cell Lymphoma; Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Sezary Syndrome; T-Cell Prolymphocytic Leukemia	Ohio State University Comprehensive Cancer Center	2020-09-15	PHASE2
NCT06118515	Not yet recruiting	Congenital Cytomegalovirus Infection	National Institute of Allergy and Infectious Diseases (NIAID)	2023-11-16	Phase 1
NCT06057194	Not yet recruiting	Infections Cytomegalovirus	Maimónides Biomedical Research Institute of Córdoba\|MERCK SHARP & DOHME DE ESPAÑA S.A.	2023-10	Phase 2
NCT05446571	Recruiting	Pregnant Women\|CMV Infected Fetuses	Assistance Publique - Hôpitaux de Paris	2023-10-20	Phase 3
NCT06001320	Recruiting	Kidney Transplant; Complications\|CMV	Virginia Commonwealth University\|Merck Sharp & Dohme LLC	2023-09-25	Early Phase 1
NCT04060277	ACTIVE_NOT_RECRUITING	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid Cell Neoplasm; Hodgkin Lymphoma; Lymphoblastic Lymphoma; Myelodysplastic Syndrome; Myelofibrosis; Myeloproliferative Neoplasm; Non-Hodgkin Lymphoma	City of Hope Medical Center	2019-11-27	PHASE2
NCT05626530	Recruiting	Cytomegalovirus Infections\|Infection in Solid Organ Transplant Recipients\|Neutropenia\|Antiviral Toxicity	Tufts Medical Center	2023-02-02	Phase 4
NCT03940586	COMPLETED	Cytomegalovirus (CMV) Infection	Merck Sharp & Dohme LLC	2019-08-08	PHASE2
NCT04129398	COMPLETED	Cytomegalovirus Infection; Cytomegalovirus Disease	Merck Sharp & Dohme LLC	2019-12-27	PHASE3
NCT03443869	COMPLETED	CMV Disease	Merck Sharp & Dohme LLC	2018-05-03	PHASE3
NCT03728426	COMPLETED	Cytomegalovirus Infections	Amy C. Sherman, MD	2019-01-11	PHASE2
NCT04732260	COMPLETED	Pregnant Women Undergoing TOP; TOP - Failed Attempted Termination of Pregnancy	Assistance Publique - Hôpitaux de Paris	2021-06-11
NCT03930615	COMPLETED	Cytomegalovirus Infection	Merck Sharp & Dohme LLC	2019-06-21	PHASE3
NCT02137772	COMPLETED	Prevention of CMV Infection or Disease	Merck Sharp & Dohme LLC	2014-06-06	PHASE3
NCT01063829	COMPLETED	HCMV Reactivation or HCMV End-Organ Disease	AiCuris Anti-infective Cures AG	2010-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Letermovir (AIC246) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Letermovir specifically targets and inhibits the viral terminase subunit complex, thereby preventing viral DNA cleavage and packaging into mature viral capsids to suppress cytomegalovirus replication. By halting late-stage viral maturation, this distinct mechanism bypasses DNA polymerase inhibitor resistance, providing viral suppression crucial for cytomegalovirus prophylaxis and management in organ transplant recipients.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).