Clinical Trials

Valganciclovir HCl has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 across infectious disease and oncology settings. These studies address cytomegalovirus infections, congenital cytomegalovirus, post-transplant complications, Epstein-Barr virus-associated lymphomas, and glioblastoma multiforme, encompassing completed, recruiting, and terminated statuses. Sponsored by academic medical centers, federal institutions, and industry partners, these protocols support applications ranging from post-transplant prophylaxis to targeted therapies for viral lymphoproliferative disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07513623 NOT_YET_RECRUITING
Cytomegalovirus (CMV); Anterior Uveitis; Infectious Uveitis; CMV Infection
University of California, San Francisco
 2026-11-01 PHASE2
NCT06798909 RECRUITING
Cytomegalovirus (CMV); Kidney Transplant; Complications; Kidney Diseases
University of California, San Francisco
 2025-07-22 PHASE3
NCT07294547 RECRUITING
Kidney Transplantation, Cytomegalovirus Infections; EBV Infection; Antiviral Prophylaxis
National Taiwan University Hospital
 2025-11-27
NCT05595473 ACTIVE_NOT_RECRUITING
Hepatocellular Carcinoma
Rznomics, Inc.
 2022-07-29 PHASE1; PHASE2
NCT06102525 RECRUITING
Glioblastoma
Rznomics, Inc.
 2024-10-08 PHASE1; PHASE2
NCT07450365 NOT_YET_RECRUITING
Congenital CMV Infection
Hu Bofei
 2026-02-15 PHASE4
NCT07571135 NOT_YET_RECRUITING
CMV Infection; CMV; CMV Viremia; CMV Disease
Elisabeth Kincaide
 2026-05 PHASE4
NCT06853184 RECRUITING
CMV Infection
Amivas Inc.
 2025-08-01 PHASE2
NCT07383649 RECRUITING
Brain Cancer Metastatic; CMV Viremia
The Methodist Hospital Research Institute
 2026-07-14 PHASE2
NCT07079735 RECRUITING
CMV Viremia; Heart Transplant Infection; Heart Transplant Failure and Rejection
Columbia University
 2025-09-12 PHASE2; PHASE3
NCT04116411 ACTIVE_NOT_RECRUITING
Glioblastoma Multiforme
Cecilia Soderberg-Naucler
 2019-09-04 PHASE2
NCT06334497 RECRUITING
Cytomegalovirus Infection
Assistance Publique - Hôpitaux de Paris
 2024-08-14 PHASE3
NCT07235683 RECRUITING
CMV; Lung Transplant Recipient
University Health Network, Toronto
 2025-12-24 PHASE4
NCT06695026 RECRUITING
Hepatocellular Carcinoma (HCC)
Rznomics, Inc.
 2024-12-18 PHASE1; PHASE2
NCT05708755 RECRUITING
Lung Transplant; Complications
NYU Langone Health
 2024-09-13 PHASE2
NCT06057194 NOT_YET_RECRUITING
Infections, Cytomegalovirus
Maimónides Biomedical Research Institute of Córdoba
 2023-10 PHASE2
NCT07379203 NOT_YET_RECRUITING
Cytomegalovirus (CMV) Infection
Wits Health Consortium (Pty) Ltd
 2026-02-01 PHASE2
NCT06439342 RECRUITING
Cytomegalovirus (CMV)
Takeda
 2024-12-16 PHASE3
NCT07266467 RECRUITING
Kidney Transplant
First Affiliated Hospital Xi'an Jiaotong University
 2025-05-13 PHASE4
NCT00092222 ACTIVE_NOT_RECRUITING
Lymphoproliferative Disorder; HHV-8; Malignancy; HIV
National Cancer Institute (NCI)
 2004-10-28 PHASE2
NCT06001320 ACTIVE_NOT_RECRUITING
Kidney Transplant; Complications; CMV
Virginia Commonwealth University
 2023-09-25 PHASE3
NCT07138989 NOT_YET_RECRUITING
Nasopharyngeal Cancinoma (NPC)
Sun Yat-sen University
 2025-08-19 PHASE2
NCT07430683 ACTIVE_NOT_RECRUITING
Cytomegalovirus Infections
University of Guadalajara
 2024-03-01 PHASE4
NCT04724447 COMPLETED
Major Depressive Disorder
Laureate Institute for Brain Research, Inc.
 2021-11-23 PHASE1; PHASE2
NCT06391918 TERMINATED
Solid Tumor, Adult
GenVivo, Inc.
 2024-03-04 PHASE1
NCT06034925 COMPLETED
Transplant Complication; CMV
Medical University of South Carolina
 2023-11-06 PHASE4
NCT05041426 COMPLETED
Lung Transplant; CMV
Fernanda P Silveira, MD, MS
 2021-12-06 PHASE2
NCT03915366 COMPLETED
Pneumonia; HIV/AIDS; Tuberculosis; Cytomegalovirus Infections
Hospital Universitario 12 de Octubre
 2020-03-01 PHASE2; PHASE3
NCT06302140 TERMINATED
Advanced Cancer
Viracta Therapeutics, Inc.
 2024-02-28 PHASE1
NCT05011058 TERMINATED
Epstein-Barr Virus Associated Lymphoma; EBV-Positive DLBCL, NOS; EBV-Related Non-Hodgkin Lymphoma; EBV Related PTCL, NOS; EBV-Related Hodgkin Lymphoma; EBV-Related PTLD; EBV-Related Lymphoproliferative Disorder
Viracta Therapeutics, Inc.
 2021-05-28 PHASE2
NCT03586284 TERMINATED
Cytomegalovirus Anterior Uveitis
University of California, San Francisco
 2020-03-15 PHASE2; PHASE3
NCT05166577 TERMINATED
Nasopharyngeal Carcinoma; EBV-Related Gastric Carcinoma; EBV-Related Leiomyosarcoma; EBV Related Carcinoma; EBV-Related Sarcoma
Viracta Therapeutics, Inc.
 2021-10-08 PHASE1
NCT06407232 Not yet recruiting
Cytomegalovirus Infections|Kidney Transplant Infection|Pancreas Transplant
University of Wisconsin Madison|Merck Sharp & Dohme LLC
 2024-05 Phase 3
NCT04064697 TERMINATED
Ulcerative Colitis, Unspecified
Centre Hospitalier Universitaire de Saint Etienne
 2021-04-22 PHASE3
NCT06034925 Recruiting
Transplant Complication|CMV
Medical University of South Carolina|Takeda
 2023-11-06 Phase 4
NCT03699254 COMPLETED
Transplantation Infection; Cytomegalovirus Infections
Maimónides Biomedical Research Institute of Córdoba
 2019-04-05 PHASE3
NCT03397706 COMPLETED
Epstein-Barr Virus-Associated Lymphoma; Lymphoproliferative Disorders
Viracta Therapeutics, Inc.
 2018-03-29 PHASE1; PHASE2
NCT03107871 TERMINATED
Cmv Congenital; CMV; Congenital Cmv; SNHL; Sensorineural Hearing Loss
Albert Park
 2018-08-31 PHASE2
NCT02927067 COMPLETED
Cytomegalovirus (CMV)
Shire
 2017-04-14 PHASE3
NCT03443869 COMPLETED
CMV Disease
Merck Sharp & Dohme LLC
 2018-05-03 PHASE3
NCT01972035 COMPLETED
Transplantation Infection; Epstein-Barr Virus Infections; Cytomegalovirus Infections
University of Minnesota
 2014-08-01 PHASE2
NCT03301415 TERMINATED
Congenital Cytomegalovirus Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-08-21 PHASE2
NCT02931539 COMPLETED
Cytomegalovirus (CMV)
Shire
 2016-12-22 PHASE3
NCT02871401 COMPLETED
Idiopathic Pulmonary Fibrosis
Vanderbilt University Medical Center
 2018-01-03 PHASE1
NCT01649869 COMPLETED
Cytomegalovirus Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-02-24 PHASE2
NCT03123627 COMPLETED
Kidney Transplant Infection
Maimónides Biomedical Research Institute of Córdoba
 2016-08-23 PHASE3
NCT03296553 COMPLETED
Kaposi Sarcoma; Human Immunodeficiency Virus; Immune Reconstitution Syndrome
National Institute of Cancerología
 2015-10-01 PHASE2
NCT03301415 Terminated
Congenital Cytomegalovirus Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-08-21 Phase 2
NCT03631316 COMPLETED
Kidney Transplantation; Cytomegalovirus Infections; Pharmacokinetics; Therapeutic Equivalency
Luis Eduardo Morales Buenrostro
 2018-03-01
NCT02606266 TERMINATED
Congenital Cytomegalovirus (CMV)
Assistance Publique - Hôpitaux de Paris
 2017-07-11 PHASE2; PHASE3
NCT01552369 COMPLETED
Cytomegalovirus Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2012-10-29 PHASE4
NCT01441063 COMPLETED
Castleman Disease; Multicentric Castleman Disease; Giant Lymph Node Hyperplasia
National Cancer Institute (NCI)
 2011-09-13 PHASE2
NCT02005822 COMPLETED
Congenital Cytomegalovirus Infection; Sensorineural Hearing Loss
Dr. Ann C.T.M. Vossen
 2013-10-22 PHASE3
NCT03698435 Unknown status
Cytomegalovirus Infections
University Medical Center Groningen
 2018-05-25 --
NCT02761291 UNKNOWN
Nasopharyngeal Carcinoma
Chang Gung Memorial Hospital
 2016-05 PHASE1
NCT02370758 COMPLETED
Cytomegalovirus Viraemia
University Health Network, Toronto
 2014-11
NCT01335932 COMPLETED
Acute Lung Injury; Acute Respiratory Distress Syndrome; Respiratory Failure
Fred Hutchinson Cancer Center
 2011-03-10 PHASE2
NCT02439957 TERMINATED
Cytomegalovirus Disease; Kidney Transplant Infection
Jazz Pharmaceuticals
 2015-09 PHASE3
NCT02439970 TERMINATED
Cytomegalovirus Disease
Jazz Pharmaceuticals
 2015-09 PHASE3
NCT00372229 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2006-05 PHASE3
NCT01663740 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2012-01-30 PHASE4
NCT02503982 COMPLETED
Infection in Solid Organ Transplant Recipients
Rabin Medical Center
 2014-12 PHASE4
NCT01255644 COMPLETED
Chronic Lymphocytic Leukemia
Medical University of Vienna
 2010-12 PHASE4
NCT01611974 COMPLETED
Cytomegalovirus (CMV)
Shire
 2012-07-17 PHASE2
NCT01509404 COMPLETED
Cytomegalovirus Disease
Medical University of South Carolina
 2011-11 PHASE4
NCT01446445 COMPLETED
Infection in Solid Organ Transplant Recipients
Nuria Lloberas
 2011-12 PHASE4
NCT01329185 COMPLETED
EBV Viremia; CMV Viremia
University of Minnesota
 2011-06 PHASE2
NCT01503918 COMPLETED
Critical Illness
University Hospital Birmingham NHS Foundation Trust
 2012-01 PHASE2
NCT00828503 UNKNOWN
Cytomegalovirus Disease
Marcus Saemann
 2008-12 PHASE2
NCT01655212 TERMINATED
Congenital Cytomegalovirus Infection; Sensorineural Hearing Loss
Dr. Ann C.T.M. Vossen
 2012-06 PHASE3
NCT01165580 COMPLETED
Cytomegalovirus Infections, Heart Transplantation
Hoffmann-La Roche
 2011-05 PHASE1
NCT01376804 COMPLETED
Kidney Transplantation, Cytomegalovirus Infections
Hoffmann-La Roche
 2011-07-31 PHASE4
NCT01185223 TERMINATED
Allogeneic Stem Cell Transplantation
Pierrel Research Europe GmbH
 2010-09 PHASE3
NCT00966836 UNKNOWN
Heart Transplantation; Cardiac Allograft Vasculopathy; Cytomegalovirus Infection
University of Bologna
 2009-04 PHASE3
NCT00466817 COMPLETED
Cytomegalovirus Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-06 PHASE3
NCT02297854 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2011-07 PHASE1
NCT02296723 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2011-07 PHASE1
NCT00992732 TERMINATED
Lymphoid Malignancies; Lymphoproliferative Disorders
HemaQuest Pharmaceuticals Inc.
 2010-05 PHASE2
NCT00330018 COMPLETED
Bone Marrow Transplantation; Cytomegalovirus
Hadassah Medical Organization
 2006-02 PHASE3
NCT00386412 COMPLETED
Cytomegalovirus Infection
PETHEMA Foundation
 2005-11 PHASE2
NCT00917826 TERMINATED
EBV Lymphomas; Lympho-proliferative Diseases
HemaQuest Pharmaceuticals Inc.
 2008-09 PHASE2
NCT00361933 WITHDRAWN
Giant Lymph Node Hyperplasia
University of Washington
 2008-12 PHASE4
NCT00264290 COMPLETED
HIV Infections; Cytomegalovirus Infections
University of California, San Francisco
 2006-08 PHASE4
NCT00294515 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2006-03-31 PHASE3
NCT00431353 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2004-04 PHASE4
NCT00400322 COMPLETED
Glioblastoma Multiforme; Cytomegalovirus Infection
Karolinska Institutet
 2006-08
NCT00227370 COMPLETED
Cytomegalovirus Infections
Duke University
 2003-07 PHASE3
NCT00096538 COMPLETED
Sarcoma
Memorial Sloan Kettering Cancer Center
 2004-04
NCT00387530 WITHDRAWN
Gastric Cancer; Head and Neck Cancer; Lymphoma; Lymphoproliferative Disorder
University of California, San Diego
 2006-05 PHASE2
NCT00241345 TERMINATED
Cytomegalovirus Infections
Washington University School of Medicine
 2004-06 PHASE3
NCT00189150 COMPLETED
Kidney Transplant Recipient; Heart Transplant Recipient
University of Michigan
 2005-04 PHASE4
NCT00478465 COMPLETED
Chronic Fatigue Syndrome
Stanford University
 2007-05 PHASE1; PHASE2
NCT00275665 COMPLETED
Bone Marrow Stem Cell Transplant
Mayo Clinic
 2001-11 PHASE3
NCT00730769 COMPLETED
Cytomegalovirus Infection
Salvador Gil-Vernet
 2004-03 PHASE4
NCT00031434 COMPLETED
Cytomegalovirus Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-07 PHASE1; PHASE2
NCT00034385 COMPLETED
Kidney Trasplant
National Institutes of Health Clinical Center (CC)
 2002-04-24 PHASE4
NCT00141037 COMPLETED
Kidney Diseases; Kidney Transplantation; Kidney Transplant; Renal Transplantation; Renal Transplant
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-03 PHASE1; PHASE2
NCT00377741 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2004-12 PHASE1
NCT00090766 COMPLETED
Cytomegalovirus Infections
Hoffmann-La Roche
 2004-05 PHASE2; PHASE3
NCT00194467 COMPLETED
Human Herpesvirus 8
University of Washington
 2002-12 PHASE2
NCT00002377 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
Hoffmann-La Roche
 1997-01 PHASE3
NCT00002222 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
Hoffmann-La Roche
NCT00374686 COMPLETED
Cytomegalovirus Infection
Washington University School of Medicine
 2003-03
NCT00017784 UNKNOWN
Cytomegalovirus Retinitis; HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00198224 COMPLETED
Renal Failure
Indiana University
 2003-01
NCT00562770 COMPLETED
Chronic Lymphocytic Leukemia; Leukemia
M.D. Anderson Cancer Center
 2003-09 PHASE2
NCT00217503 COMPLETED
Lymphoma
National Cancer Institute (NCI)
 2005-07 PHASE2
NCT00237653 TERMINATED
Cytomegalovirus Infections; Inflammatory Bowel Diseases
University Hospital, Grenoble
 2004-02 PHASE3
NCT00275314 TERMINATED
Kidney Transplant
University of Pittsburgh
 2006-02 PHASE3
NCT00016068 COMPLETED
Infection
Fred Hutchinson Cancer Center
 2001-01 PHASE3
NCT00006145 COMPLETED
Cytomegalovirus Infections; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2000-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-11)

Check the Valganciclovir HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valganciclovir HCl is an L-valyl ester prodrug rapidly hydrolyzed to ganciclovir, which undergoes intracellular triphosphorylation to competitively inhibit viral DNA polymerase. This inhibition terminates viral DNA strand elongation and halts viral replication within host cells, thereby preventing viral expansion to mitigate cytomegalovirus infections and related viral complications in immunocompromised patients.

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>).

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