Drugs / Valganciclovir
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Valganciclovir

Small molecule

Developed for
cytomegalovirus infection · HIV infectious disease · disease related to solid organ transplantation · lymphoproliferative syndrome · cytomegalovirus retinitis · lymphoma · sensorineural hearing loss disorder · disease related to hematopoietic stem cell transplant
+30 more · fetal cytomegalovirus syndrome · gastric cancer · human herpesvirus 8 infection · nasopharyngeal carcinoma · B-cell chronic lymphocytic leukemia · Castleman disease · diffuse large B-cell lymphoma · Epstein-Barr virus infection · Epstein-Barr virus-associated gastric carcinoma · Epstein-Barr virus-associated lymphoproliferative disorder · Epstein-Barr virus-associated mesenchymal tumor · head and neck cancer · Hodgkins lymphoma · idiopathic pulmonary fibrosis · immune reconstitution inflammatory syndrome · infectious disease · inflammatory bowel disease · Kaposi's sarcoma · KSHV inflammatory cytokine syndrome · lymphoid neoplasm · major depressive disorder · multicentric Castleman disease · myalgic encephalomeyelitis/chronic fatigue syndrome · peripheral T-cell lymphoma, not otherwise specified · post-transplant lymphoproliferative disease · sarcoma · ulcerative colitis · anterior uveitis · glioblastoma · uveitis
Investigated by
Hoffmann-La Roche · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · Roche Pharma AG · Viracta Therapeutics, Inc. · Dr. Ann C.T.M. Vossen
+97 more · Dr. Reddy's Laboratories Limited · Fred Hutchinson Cancer Center · Genentech, Inc. · HemaQuest Pharmaceuticals Inc. · Leiden University Medical Center · Maimónides Biomedical Research Institute of Córdoba · Stichting Nuts Ohra · University Hospital, Bordeaux · University of California, San Francisco · University of Michigan · University of Washington · Washington University School of Medicine · Albert Park · Assistance Publique - Hôpitaux de Paris · Barcelona Institute for Global Health · Beijing Chao Yang Hospital · Beijing Tsinghua Changgeng Hospital · Boston University · Centre Hospitalier Cocody · Chinese People's Liberation Army Northern Theater Command General Hospital · City of Hope National Medical Center · Eastern Theater General Hospital · Eduardo Mondlane University · Elisabeth Kincaide · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital, Sun Yat-Sen University · French National Institute of Health and Medical Research · Hadassah Medical Organization · Hospital Universitario 12 de Octubre · Hospital Universitario La Paz · Hu Bofei · Huzhou Maternity and Child Care Hospital · Infectious Diseases Institute, Uganda · Instituto de Salud Carlos III · Jiangxi Maternal and Child Health Hospital · Jiaxing Maternity and Child Health Care Hospital · Kamuzu Central Hospital · Laureate Institute for Brain Research, Inc. · London School of Hygiene and Tropical Medicine · Luis Eduardo Morales Buenrostro · Makerere University · Malawi-Liverpool-Wellcome Trust Clinical Research Programme · Manhiça Health Research Centre · Mayo Clinic · Medical University of Vienna · Memorial Sloan Kettering Cancer Center · Mexican Social Security Institute · Ministry of Health, France · Nanfang Hospital, Southern Medical University · National Institute for Health Research, United Kingdom · National Institute of Cancerology · National Institute of Respiratory Diseases · National Institute on Deafness and Other Communication Disorders (NIDCD) · National Institutes of Health Clinical Center (CC) · New York Presbyterian Hospital · Ningbo Women & Children's Hospital · PENTA Foundation · PETHEMA Foundation · Pierrel Research Europe GmbH · Qianfo Mountain Hospital, Shandong Province · Quzhou Maternal and Child Health Care Hospital · Rabin Medical Center · RenJi Hospital · Salvador Gil-Vernet · Samsung Medical Center · Second Affiliated Hospital of Guangzhou Medical University · Second Affiliated Hospital of Wenzhou Medical University · Servicio Madrileño de Salud, Madrid, Spain · Shanghai Zhongshan Hospital · Shu lan Hospital · St George's, University of London · Stanford University · Stichting Katholieke Universiteit · Sun Yat-sen University · all 103 on the full record

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (5) US (FDA) VALCYTE — 2003-09-12 – 2018-08-02 fda.gov ↗
Approved US (FDA) VALCYTE — 2001-03-29 fda.gov ↗

Trials 70 · started per year

today
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19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT05166577 Oct 2021 → Oct 2024 Epstein-Barr virus-associated gastric carcinoma, Epstein-Barr virus-associated mesenchymal tumor, nasopharyngeal carcinoma Viracta Therapeutics, Inc. Terminated No outcome recorded Stop: Business
Phase 1 NCT02871401 Jan 2018 → Jan 2020 idiopathic pulmonary fibrosis Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT02297854 Jul 2011 — Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 1 NCT02296723 Jul 2011 — Dr. Reddy's Laboratories Limited Completed No outcome recorded
Phase 1 NCT01165580 May 2011 → Sep 2013 cytomegalovirus infection Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT00377741 Dec 2004 → Jun 2006 cytomegalovirus infection Hoffmann-La Roche Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT04724447 Nov 2021 → Apr 2026 major depressive disorder Laureate Institute for Brain Research, Inc. Completed No outcome recorded
Phase 1/2 NCT03397706 Mar 2018 → Apr 2023 Epstein-Barr virus-associated lymphoproliferative disorder, lymphoproliferative syndrome Viracta Therapeutics, Inc. Completed No outcome recorded
Phase 1/2 NCT00478465 May → Aug 2007 myalgic encephalomeyelitis/chronic fatigue syndrome Stanford University Completed No outcome recorded
Phase 1/2 NCT00031434 Jul 2002 → Jul 2007 cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 218 trials · 1 met primary
Phase 2 NCT07383649 May 2026 → May 2028 expected cytomegalovirus infection, metastatic malignant neoplasm in the brain The Methodist Hospital Research Institute Recruiting No outcome recorded
Phase 2 NCT07379203 Feb 2026 → Feb 2027 expected cytomegalovirus infection Wits Health Consortium (Pty) Ltd Not yet recruiting No outcome recorded
Phase 2 NCT07138989 Aug 2025 → Aug 2026 overdue nasopharyngeal carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT05011058 May 2021 → Dec 2024 Hodgkins lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified, post-transplant lymphoproliferative disease Viracta Therapeutics, Inc. Terminated No outcome recorded Stop: Business
Phase 2 NCT03301415 Aug 2019 → Nov 2020 cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2 NCT03107871 Aug 2018 → Jul 2022 overdue cytomegalovirus infection, sensorineural hearing loss disorder Albert Park Active not recruiting No outcome recorded
Phase 2 NCT03339661 Nov 2017 → Nov 2020 disease related to solid organ transplantation University Hospital, Bordeaux Completed No outcome recorded
Phase 2 NCT03296553 Oct 2015 → Aug 2019 HIV infectious disease, Kaposi's sarcoma, immune reconstitution inflammatory syndrome National Institute of Cancerology Completed No outcome recorded
Phase 2 NCT01503918 Jan 2012 → Jan 2014 — University Hospital Birmingham NHS Foundation Trust Completed Met primary
Phase 2 NCT01441063 Sep 2011 → Jun 2018 multicentric Castleman disease National Cancer Institute (NCI) Completed No outcome recorded
Phase 2/33 trials · 1 missed
Phase 2/3 NCT03915366 Mar 2020 → Jan 2025 HIV infectious disease, cytomegalovirus infection, pneumonia, tuberculosis Hospital Universitario 12 de Octubre Completed Missed primary
Phase 2/3 NCT02606266 Jul 2017 → Jul 2018 fetal cytomegalovirus syndrome Assistance Publique - Hôpitaux de Paris Terminated No outcome recorded
Phase 2/3 NCT00090766 May 2004 → May 2005 cytomegalovirus infection Hoffmann-La Roche Completed No outcome recorded
Phase 318 trials · 1 met primary · 2 missed
Phase 3 NCT06798909 Jul 2025 → Nov 2030 expected cytomegalovirus infection, kidney disorder University of California, San Francisco Recruiting No outcome recorded
Phase 3 NCT04064697 Apr 2021 → Nov 2023 ulcerative colitis University Hospital of Saint-Etienne Terminated No outcome recorded
Phase 3 NCT03699254 Apr 2019 → May 2023 cytomegalovirus infection, disease related to solid organ transplantation Maimónides Biomedical Research Institute of Córdoba Completed Met primary
Phase 3 NCT03123627 Aug 2016 → Oct 2019 disease related to solid organ transplantation Maimónides Biomedical Research Institute of Córdoba Completed No outcome recorded
Phase 3 NCT02005822 Oct 2013 → May 2018 cytomegalovirus infection, sensorineural hearing loss disorder Dr. Ann C.T.M. Vossen Completed No outcome recorded
Phase 3 NCT01655212 Jun 2012 → Oct 2013 cytomegalovirus infection, sensorineural hearing loss disorder Dr. Ann C.T.M. Vossen Terminated No outcome recorded
Phase 3 NCT01185223 Sep 2010 → Dec 2012 disease related to hematopoietic stem cell transplant Pierrel Research Europe GmbH Terminated No outcome recorded
Phase 3 NCT00966836 Apr 2009 → Apr 2012 cytomegalovirus infection University of Bologna Unknown No outcome recorded
Phase 3 NCT00466817 Jun 2008 → Dec 2011 cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 3 NCT00372229 May 2006 → Oct 2015 cytomegalovirus infection Hoffmann-La Roche Completed Mixed
Phase 416 trials · 2 met primary · 1 missed
Phase 4 NCT07571135 May 2026 → Nov 2028 expected cytomegalovirus infection Elisabeth Kincaide Not yet recruiting No outcome recorded
Phase 4 NCT07450365 Feb 2026 → Dec 2028 expected fetal cytomegalovirus syndrome Hu Bofei Not yet recruiting No outcome recorded
Phase 4 NCT07203664 Oct 2025 → Dec 2026 expected — Hospital Universitario La Paz Not yet recruiting No outcome recorded
Phase 4 NCT07266467 May 2025 → Nov 2026 expected — First Affiliated Hospital Xi'an Jiaotong University Recruiting No outcome recorded
Phase 4 NCT07430683 Mar 2024 → Jul 2026 overdue cytomegalovirus infection University of Guadalajara Active not recruiting No outcome recorded
Phase 4 NCT02503982 Dec 2014 → Aug 2015 disease related to solid organ transplantation Rabin Medical Center Completed No outcome recorded
Phase 4 NCT01552369 Oct 2012 → Jun 2018 cytomegalovirus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed Met primary
Phase 4 NCT01663740 Jan 2012 → Sep 2015 cytomegalovirus infection Hoffmann-La Roche Completed Missed primary
Phase 4 NCT01376804 Jul 2011 → May 2013 cytomegalovirus infection Hoffmann-La Roche Completed No outcome recorded
Phase 4 NCT01255644 Dec 2010 → Jul 2015 B-cell chronic lymphocytic leukemia Medical University of Vienna Completed No outcome recorded
Phase not applicable5 trials
— NCT05431244 Jul 2022 → Jul 2024 gastric cancer Samsung Medical Center Withdrawn No outcome recorded
— NCT03631316 Mar → Oct 2018 cytomegalovirus infection Luis Eduardo Morales Buenrostro Completed No outcome recorded
— NCT00096538 Apr 2004 → Feb 2008 sarcoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
— NCT00374686 Mar 2003 → Sep 2005 cytomegalovirus infection Washington University School of Medicine Completed No outcome recorded
— NCT00002222 — HIV infectious disease, cytomegalovirus retinitis Hoffmann-La Roche Completed No outcome recorded
Comparator or background therapy38 trials
Phase 1 NCT06391918 Background Mar 2024 → Mar 2026 cancer GenVivo, Inc. Terminated No outcome recorded Stop: Business
Phase 1 NCT06302140 Background Feb 2024 → Jan 2025 — Viracta Therapeutics, Inc. Terminated No outcome recorded Stop: Business
Phase 1 NCT02761291 Background May 2016 → Jun 2017 nasopharyngeal carcinoma Chang Gung Memorial Hospital Unknown No outcome recorded
Phase 1/2 NCT06695026 Background Dec 2024 → Aug 2027 expected hepatocellular carcinoma Rznomics, Inc. Recruiting No outcome recorded
Phase 1/2 NCT05595473 Background Jul 2022 → Mar 2029 expected hepatocellular carcinoma Rznomics, Inc. Active not recruiting No outcome recorded

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 114 sources stand behind the page.

FieldValueCited text
Known as (val)ganciclovir “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 ↗
104

“Valganciclovir (900mg) will be administered orally twice/day or Ganciclovir (5 mg/kg) will be administered i.v. over 1 hour for 14 days for cycle 1 and for 7 days (up to...” NCT01419561 ↗

“The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein...” NCT05431244 ↗

“initiating antiviral treatment with valganciclovir (900 mg every 12 hours, adjusted according to renal function as per the technical data sheet)” NCT07203664 ↗

“After prophylaxis, preemptive therapy (valganciclovir 900 mg twice daily) was indicated in both arms until month 6.” PMID 34228099 ↗ Mar 2022

“secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring.” NCT03339661 ↗

“4.2.2 Valganciclovir Dosing: 16 mg/kg/dose PO q12h” NCT05564598 ↗

“Oral valganciclovir 900mg twice daily” NCT01077908 ↗

“Oral valganciclovir 900mg twice daily” NCT01220895 ↗

“RZ-001 with Valganciclovir (VGCV)” NCT05595473 ↗

“Valganciclovir; 900mg D8” NCT05431244 ↗

Show 94 more sources

Known as GCV “The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein...” NCT05431244 ↗
Known as NSC-760349 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as RO-107-9070/194 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as Rovalcyte “Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension)” NCT02606266 ↗
Known as RS-079070-194 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as RS-79070-194 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as VAL “14 days of the anti-viral Valganciclovir (VAL) to kidney donors prior to the transplant compared to placebo” NCT01329185 ↗
Known as Valcyte “VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients” NCT00431353 ↗
10

“Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV)” NCT00478465 ↗

“Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.” NCT01649869 ↗

“IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients” NCT00294515 ↗

“Valcyte (valganciclovir) powder for oral solution” NCT01165580 ↗

“Valganciclovir Oral Solution [Valcyte]” NCT03915366 ↗

“Drug: valganciclovir [Valcyte]” NCT00090766 ↗

“valganciclovir [Valcyte]” NCT00377741 ↗

“Valganciclovir (Valcyte)” NCT07294547 ↗

“Valcyte (valganciclovir)” NCT01376804 ↗

“Valganciclovir (Valcyte)” NCT00400322 ↗

Known as Valcyte(TM) “Combined with valganciclovir, or Valcyte(TM), it is likely to be more toxic to bone marrow.” NCT00092222 ↗
Known as Valgan “The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the...” NCT00227370 ↗
Known as Valganciclovir (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as Valganciclovir (Valcyte) “Valganciclovir (Valcyte®)” NCT00730769 ↗
1

“Valganciclovir (Valcyte)” NCT00264290 ↗

Known as Valganciclovir hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL1201314 ↗
Known as valganciclovir hydrochloride “Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.” NCT01649869 ↗
4

“with valacyclovir hydrochloride (n = 34) or low-dose valganciclovir hydrochloride” PMID 28437539 ↗ Jun 2017

“Drug: Valganciclovir Hydrochloride” NCT03586284 ↗

NCT02297854 ↗

NCT02296723 ↗

Known as Valgancyclovir ClinicalTrials.gov intervention name — accepted as the source's own label NCT00078559 ↗
Known as valGCV “For universal prophylaxis, the antivirals most commonly used are valganciclovir (valGCV) and IV ganciclovir.” NCT03631316 ↗
Known as VGC “The two antiviral prophylaxis medications this study is comparing, valganciclovir (VGC) and maribavir, are highly effective at preventing CMV infection.” PMID 41018408 ↗ Aug 2025
1

“Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.” NCT01441063 ↗

Known as VGCV “PURPOSE: To describe cytomegalovirus (CMV) end-organ disease (EOD) rate in AIDS patients with low CD4+ cell count despite HAART who were enrolled in a randomized,...” PMID 19632953 ↗ May 2009
6

“Thirty CFS patients with elevated IgG antibody titers against HHV-6 and EBV were randomized 2:1 to receive valganciclovir (VGCV) or placebo for 6 months in a double-blind,...” PMID 23959519 ↗ Aug 2013

“Treatment of solid-organ transplant (SOT) patients with ganciclovir (GCV)-valganciclovir (VGCV) according to the manufacturer's recommendations may result in over- or underexposure.” PMID 26824942 ↗ Mar 2016

“900 milligrams (mg) valganciclovir (VGCV) to be taken orally once per day for 8 weeks.” NCT04724447 ↗

“Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices” NCT06853184 ↗

“valganciclovir (antiviral, VGCV)” NCT00189150 ↗

“Valganciclovir (VGCV)” NCT06695026 ↗

Action Deplete “Specific viral encoded genes appear to convert zidovudine and ganciclovir (or valganciclovir) into toxic phosphorylated moieties within the KSHV-infected tumor cells, to...” NCT00092222 ↗
Modality Small molecule “The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein...” NCT05431244 ↗
Route Oral “Valganciclovir, an Oral Prodrug of Ganciclovir” NCT00002222 ↗