Drugs / Ganciclovir
Ganciclovir
also known as
DHPG · GCV · Cytovene · Ganciclovir Sodium · Anti-Infective Prophylaxis · BW 759U · Cimeven · Cymevene · +16 more
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | CYTOVENE | — | 1992-05-15 – 2018-08-06 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Vitrasert Implant | — | 2002-04-02 | europa.eu ↗ |
| Approved | EU (EMA) | Vitrasert Implant | — | 1997-03-18 | europa.eu ↗ |
| Approved | US (FDA) | CYTOVENE | — | 1989-06-23 | fda.gov ↗ |
Trials 73 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 38 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03338777 Background | Feb 2020 | melanoma | Hospital Italiano de Buenos Aires | Terminated | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05578820 Background | Jan 2022 → Apr 2024 | anus neoplasm, breast neoplasm, cervical cancer, head and neck squamous cell carcinoma +4 | Gene Surgery LLC | Completed | No outcome recorded |
| Phase 1 | NCT02188719 Background | Dec 2014 → Jun 2019 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1 | NCT00964756 Background | Aug 2009 → Dec 2010 | ovarian cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 1 | NCT00006480 Background | May 2000 → Mar 2005 | neuroblastoma | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00002824 Background | Feb 1996 → ? | central nervous system neoplasm | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00141037 Background | Mar 2004 → Sep 2006 | kidney disorder | National Institute of Allergy and Infectious Diseases (NIAID) | 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 | NCT06971913 Background | May → Sep 2025 overdue | cytomegalovirus infection, systemic lupus erythematosus | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06474442 Background | Apr 2025 → Dec 2026 expected | stromal keratitis | Shanghai BDgene Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06574789 Comparator | Oct 2024 → Jun 2028 expected | cytomegalovirus infection | Murdoch Childrens Research Institute | 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 | NCT01220895 Background | Oct 2010 → Dec 2013 | cytomegalovirus infection | Cell Medica Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00986557 Background | Sep 2009 → Aug 2013 | graft versus host disease | University Hospital Birmingham | Unknown | No outcome recorded |
| Phase 2 | NCT00828503 Comparator | Dec 2008 → Dec 2013 | cytomegalovirus infection | Marcus Saemann | Unknown | No outcome recorded |
| Phase 2 | NCT00870181 Background | Jan 2008 → Dec 2011 | glioblastoma | Huazhong University of Science and Technology | Completed | No outcome recorded |
| Phase 2 | NCT00014911 Background | Apr 2001 → Jun 2005 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00001061 Background | ? → Mar 1998 | HIV infectious disease, cytomegalovirus retinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03586284 Comparator | Mar 2020 → Nov 2024 | uveitis | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06341686 Comparator | May 2024 → Mar 2025 | cytomegalovirus infection | Hospital do Rim e Hipertensão | Unknown | No outcome recorded |
| Phase 3 | NCT03699254 Background | Apr 2019 → May 2023 | cytomegalovirus infection, disease related to solid organ transplantation | Maimónides Biomedical Research Institute of Córdoba | Completed | No outcome recorded |
| Phase 3 | NCT02931539 Comparator | Dec 2016 → Aug 2020 | cytomegalovirus infection | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01600365 Comparator | May → Jun 2012 | adenoviridae infectious disease, conjunctivitis | Adapt Produtos Oftalmológicos Ltda. | Unknown | No outcome recorded |
| Phase 3 | NCT01077908 Background | Jul 2008 → Sep 2014 | cytomegalovirus infection | Cell Medica Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00497796 Comparator | Jul 2007 → Sep 2009 | cytomegalovirus infection | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00372229 Comparator | May 2006 → Oct 2015 | cytomegalovirus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00016068 Background | Jan 2001 → Sep 2007 | infectious disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00000134 Comparator | Dec 1992 → Mar 1995 | AIDS, cytomegalovirus retinitis | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07235683 Background | Dec 2025 → Aug 2027 expected | cytomegalovirus infection | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 4 | NCT03004261 Background | Nov 2016 → Dec 2021 | cytomegalovirus infection, hematologic disorder | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT02152358 Comparator | Feb 2014 → Apr 2018 | viral pneumonia | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 4 | NCT01533480 Comparator | Jan 2012 → Dec 2014 | keratoconjunctivitis | Lifelong Vision Foundation | 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 not applicable4 trials | ||||||
| — | NCT06757907 Comparator | Oct → Dec 2024 | herpes simplex virus keratitis | Al-Azhar University | Completed | No outcome recorded |
| — | NCT02370758 Comparator | Nov 2014 → Sep 2016 | cytomegalovirus infection | University Health Network, Toronto | Completed | No outcome recorded |
| — | NCT00023231 Background | Feb 2001 → Aug 2004 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00716911 Background | Jan 2000 → Jul 2007 | leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative disease, myeloproliferative neoplasm +1 | City of Hope Medical Center | Completed | No outcome recorded |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 114 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ganciclovir | “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 ↗109“replication-deficient adenovirus mutant thymidine kinase (ADV-TK) in combination with ganciclovir administration in patients with recurrent high-grade glioma” PMID 26716896 ↗ Jan 2016 “Intravenous ganciclovir and/or oral Valcyte will be administered for the prophylaxis of cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)” NCT02188719 ↗ “Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.” NCT06474442 ↗ “Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.” NCT06474416 ↗ “4.2.3 Ganciclovir Dosing: 6 mg/kg/dose IV q12h” NCT05564598 ↗ “Intravenous ganciclovir 5mg/kg twice daily” NCT01077908 ↗ “Intravenous ganciclovir 5mg/kg twice daily” NCT01220895 ↗ “Ganciclovir 1.5 mg/g ophtalmic gel” NCT01156025 ↗ “0.15% ganciclovir gel(Zirgan)” NCT01533480 ↗ “prodrug (ganciclovir: GCV)” NCT03338777 ↗ |
| Known as | Anti-Infective Prophylaxis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02188719 ↗ |
| Known as | BW 759U | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Cimeven | “Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days.” NCT05578820 ↗ |
| Known as | Cymevene | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Cytovene | “The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir).” NCT00000136 ↗2“A drug called ganciclovir (Cytovene) can kill the virus.” NCT00001328 ↗ “Intravenous Cytovene (Ganciclovir Sodium)” NCT00002034 ↗ |
| Known as | Cytovene iv | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | DHPG | “A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital...” NCT00001100 ↗9“The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS.” NCT00002299 ↗ “Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection” NCT00000995 ↗ “Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis” NCT00002273 ↗ “effectiveness and safety of ganciclovir (DHPG) therapy” NCT00000673 ↗ “intravenous ganciclovir (also known as DHPG)” NCT00000698 ↗ “long-term ganciclovir (DHPG) therapy” NCT00002034 ↗ “injections of ganciclovir (DHPG)” NCT00000688 ↗ “ganciclovir (DHPG)” NCT00000970 ↗ “ganciclovir (DHPG)” NCT00001999 ↗ |
| Known as | Dihydroxypropoxymethyl Guanine | “A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital...” NCT00001100 ↗ |
| Known as | Ganciclovir (as sodium) | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Ganciclovir (Cymevene) | “Ganciclovir (Cymevene®)” NCT00730769 ↗ |
| Known as | Ganciclovir Ophthalmic Gel | “Ganciclovir Ophthalmic Gel” NCT06474416 ↗ |
| Known as | Ganciclovir Sodium | “Intravenous Cytovene (Ganciclovir Sodium)” NCT00002034 ↗ |
| Known as | Ganciclovir sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | gancyclovir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02382588 ↗ |
| Known as | Ganzyk-rtu | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | GCV | “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 20169“Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis” NCT00000698 ↗ “ganciclovir (GCV) and zidovudine (AZT) when given in combination.” NCT00000995 ↗ “co-administered with GCV (12.5 mg/ml)” NCT03338777 ↗ “Ganciclovir (GCV)” NCT00964756 ↗ “Ganciclovir (GCV)” NCT06971913 ↗ “Ganciclovir (GCV)” NCT06853184 ↗ “Ganciclovir (GCV)” NCT07513623 ↗ “Ganciclovir (GCV)” NCT06757907 ↗ “Ganciclovir (GCV)” NCT03217474 ↗ |
| Known as | NSC-759656 | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | RS-21592 | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | RS-21592 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Valganciclovir hydrochloride impurity a | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Virgan | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Vitrasert | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Vitrasert implant | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Known as | Zirgan | ChEMBL registry synonym — accepted as the source's own label CHEMBL182 ↗ |
| Action | Inhibit | “arginine butyrate was not only effective in inducing EBV thymidine kinase transcription, but also acted synergistically with the antiviral agent ganciclovir to inhibit cell...” PMID 9628848 ↗ Jun 1998 |
| Modality | Small molecule | — CHEMBL182 ↗ |
| Route | Intravenous | “intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day” NCT00000134 ↗ |