Valganciclovir
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
Also used as a comparator or background therapy in 38 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06391918 Background | Mar 2024 → Mar 2026 | cancer | GenVivo, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT06302140 Background | Feb 2024 → Jan 2025 | — | Viracta Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02761291 Background | May 2016 → Jun 2017 | nasopharyngeal carcinoma | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 1/24 trials | ||||||
| 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 |
| Phase 1/2 | NCT00141037 Background | Mar 2004 → Sep 2006 | kidney disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00078559 Background | Nov 2003 → Feb 2010 | kidney disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07513623 Comparator | Jul 2026 → Dec 2031 expected | anterior uveitis, cytomegalovirus infection | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06853184 Comparator | Aug 2025 → May 2028 expected | cytomegalovirus infection | Amivas Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05708755 Background | Sep 2024 → May 2027 expected | — | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT05564598 Background | Jul 2023 → Oct 2027 expected | fetal cytomegalovirus syndrome | New York Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05041426 Comparator | Dec 2021 → Mar 2025 | cytomegalovirus infection | Fernanda P Silveira, MD, MS | Completed | No outcome recorded |
| Phase 2 | NCT04116411 Comparator | Sep 2019 → Sep 2027 expected | glioblastoma | Cecilia Soderberg-Naucler | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01649869 Comparator | Feb 2015 → Dec 2019 | cytomegalovirus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01972035 Comparator | Aug 2014 → Feb 2021 | Epstein-Barr virus infection, cytomegalovirus infection, disease related to solid organ transplantation | University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT01220895 Background | Oct 2010 → Dec 2013 | cytomegalovirus infection | Cell Medica Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00828503 Comparator | Dec 2008 → Dec 2013 | cytomegalovirus infection | Marcus Saemann | Unknown | No outcome recorded |
| Phase 2 | NCT00092222 Comparator | Oct 2004 → Oct 2026 expected | HIV infectious disease, cancer, human herpesvirus 8 infection, lymphoproliferative syndrome | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00562770 Comparator | Sep 2003 → Jul 2006 | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07079735 Comparator | Sep 2025 → Jan 2028 expected | cytomegalovirus infection, disease related to solid organ transplantation, transplant rejection | Columbia University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03586284 Comparator | Mar 2020 → Nov 2024 | uveitis | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06334497 Background | Aug 2024 → Sep 2027 expected | cytomegalovirus infection | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT03443869 Comparator | May 2018 → Apr 2022 | cytomegalovirus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02927067 Comparator | Apr 2017 → Jul 2022 | cytomegalovirus infection | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02931539 Comparator | Dec 2016 → Aug 2020 | cytomegalovirus infection | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02439957 Comparator | Sep 2015 → May 2016 | cytomegalovirus infection, disease related to solid organ transplantation | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02439970 Comparator | Sep 2015 → Jan 2016 | cytomegalovirus infection | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01077908 Background | Jul 2008 → Sep 2014 | cytomegalovirus infection | Cell Medica Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00294515 Comparator | Mar 2006 → Aug 2008 | cytomegalovirus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00227370 Comparator | Jul 2003 → Apr 2008 | cytomegalovirus infection | Duke University | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07235683 Background | Dec 2025 → Aug 2027 expected | cytomegalovirus infection | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 4 | NCT06034925 Comparator | Nov 2023 → Jun 2025 | cytomegalovirus infection, disease related to solid organ transplantation | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT01446445 Comparator | Dec 2011 → Aug 2014 | disease related to solid organ transplantation | Nuria Lloberas | Completed | No outcome recorded |
| Phase 4 | NCT01509404 Comparator | Nov 2011 → Dec 2014 | cytomegalovirus infection | Medical University of South Carolina | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07294547 Comparator | Nov 2025 → Dec 2029 expected | Epstein-Barr virus infection, cytomegalovirus infection | National Taiwan University Hospital | Recruiting | No outcome recorded |
| — | NCT02370758 Comparator | Nov 2014 → Sep 2016 | cytomegalovirus infection | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT00400322 Comparator | Aug 2006 → Jun 2008 | cytomegalovirus infection, glioblastoma | Karolinska Institutet | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01049633 Background | — | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | No longer available | No outcome recorded |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 114 sources stand behind the page.
| Field | Value | Cited 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” NCT01220895 ↗ “Oral valganciclovir 900mg twice daily” NCT01077908 ↗ “RZ-001 with Valganciclovir (VGCV)” NCT05595473 ↗ “Valganciclovir; 900mg D8” NCT05431244 ↗ “Valganciclovir (VGCV)” NCT06695026 ↗ |
| 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)” NCT07294547 ↗ “valganciclovir [Valcyte]” NCT00377741 ↗ “Valganciclovir (Valcyte)” NCT00400322 ↗ “Valcyte (valganciclovir)” NCT01376804 ↗ |
| 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 ↗ |
| 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 20251“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 20096“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 | Inhibit | “administration of valganciclovir as an anti-HHV-8 agent can diminish viral replication prior to administration of cART” NCT03296553 ↗ |
| 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 ↗ |