Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 studies and post-marketing surveillance have evaluated maribavir, primarily for cytomegalovirus (CMV) infections—including post-transplant complications—as well as in healthy volunteers and patients with hematologic malignancies, HIV, or kidney disease. Sponsored by commercial entities such as Takeda, Shire, and Glaxo Wellcome, alongside academic institutions including the Institute of Hematology & Blood Diseases Hospital in China and Seoul National University Hospital, these studies comprise completed, actively recruiting, and not yet recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07511127 RECRUITING
Hematologic Malignancy
Ruijin Hospital
 2026-02-28 PHASE3
NCT07014319 RECRUITING
Cytomegalovirus (CMV)
Seoul National University Hospital
 2025-11-03 PHASE2
NCT05319353 RECRUITING
Cytomegalovirus (CMV)
Takeda
 2023-11-13 PHASE3
NCT06439342 RECRUITING
Cytomegalovirus (CMV)
Takeda
 2024-12-16 PHASE3
NCT06034925 COMPLETED
Transplant Complication; CMV
Medical University of South Carolina
 2023-11-06 PHASE4
NCT05918822 COMPLETED
Healthy Volunteers
Takeda
 2023-07-25 PHASE1
NCT05137717 COMPLETED
Cytomegalovirus (CMV)
Takeda
 2022-01-18 PHASE3
NCT05382104 COMPLETED
Healthy Volunteers
Takeda
 2022-05-25 PHASE1
NCT02927067 COMPLETED
Cytomegalovirus (CMV)
Shire
 2017-04-14 PHASE3
NCT04497883 COMPLETED
Healthy Volunteers
Shire
 2020-08-07 PHASE1
NCT02931539 COMPLETED
Cytomegalovirus (CMV)
Shire
 2016-12-22 PHASE3
NCT04131556 TERMINATED
Healthy Volunteers
Shire
 2019-10-25 PHASE1
NCT02775240 COMPLETED
Cytomegalovirus (CMV)
Shire
 2016-07-21 PHASE1
NCT01611974 COMPLETED
Cytomegalovirus (CMV)
Shire
 2012-07-17 PHASE2
NCT00497796 COMPLETED
Cytomegalovirus Infections
Shire
 2007-07-23 PHASE3
NCT00411645 COMPLETED
Cytomegalovirus Infections
Shire
 2006-12-13 PHASE3
NCT00223925 COMPLETED
Cytomegalovirus Infection
Shire
 2004-10-28 PHASE2
NCT00002373 COMPLETED
Cytomegalovirus Infections; HIV Infections
Glaxo Wellcome
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-06)

Check the Maribavir（1263W94， BW1263W94，GW257406X，GW 1263） product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Maribavir acts as a competitive adenosine triphosphate inhibitor that selectively targets the human cytomegalovirus pUL97 kinase with an IC50 of 3 nM and a Ki of 10 nM, thereby disrupting essential viral kinase activity and downstream replication pathways. This suppression of viral maturation accounts for its therapeutic efficacy in managing cytomegalovirus infections and post-transplant viral complications evaluated in clinical trials.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.