U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Description

Ganciclovir is a synthetic acyclic nucleoside analogue of 2'-deoxyguanosine active against cytomegalovirus. Ganciclovir has been shown to be active against cytomegalovirus (CMV) and herpes simplex virus (HSV) in humans. To achieve anti-CMV activity, ganciclovir is phosphorylated first to the monophosphate form by a CMV-encoded (UL97 gene) protein kinase homologue, then to the di- and triphosphate forms by cellular kinases. Ganciclovir triphosphate concentrations may be 100-fold greater in CMV-infected than in uninfected cells, indicating preferential phosphorylation in infected cells. Ganciclovir triphosphate, once formed, persists for days in the CMV-infected cell. Ganciclovir triphosphate is believed to inhibit viral DNA synthesis by (1) competitive inhibition of viral DNA polymerases; and (2) incorporation into viral DNA, resulting in eventual termination of viral DNA elongation. Ganciclovir is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS) and for the treatment of acute herpetic keratitis.

Originator

Curator's Comment: The first synthesis of ganciclovir was reported by Julien Verheyden and John Martin at Syntex Research in California in 1980 and is marketed as sodium salt (Ganciclovir sodium) under the trade names Cytovene and Cymevene.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Target ID: P08546
Gene ID: NA
Gene Symbol: UL54
Target Organism: Human cytomegalovirus (strain AD169) (HHV-5) (Human herpesvirus 5)
0.08 µM [EC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
ZIRGAN

Approved Use

ZIRGAN is a topical ophthalmic antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

Launch Date

1995
Primary
CYTOVENE

Approved Use

CYTOVENE-IV is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). CYTOVENE-IV is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease.

Launch Date

1994
Primary
VALCYTE

Approved Use

VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)

Launch Date

2001
Primary
VALCYTE

Approved Use

VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk

Launch Date

2001
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
4.8 mg/L
1 g 3 times / day multiple, oral
dose: 1 g
route of administration: Oral
experiment type: MULTIPLE
co-administered:
GANCICLOVIR plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
13.3 μg/mL
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
GANCICLOVIR plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
35.4 mg × h/L
1 g 3 times / day multiple, oral
dose: 1 g
route of administration: Oral
experiment type: MULTIPLE
co-administered:
GANCICLOVIR plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
53.8 μg × h/mL
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
GANCICLOVIR plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
5.2 h
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
GANCICLOVIR plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
1000 mg 6 times / day multiple, oral
Highest studied dose
Dose: 1000 mg, 6 times / day
Route: oral
Route: multiple
Dose: 1000 mg, 6 times / day
Sources:
unhealthy, 37.4
n = 19
Health Status: unhealthy
Condition: AIDS
Age Group: 37.4
Population Size: 19
Sources:
2000 mg 3 times / day multiple, oral
Highest studied dose
Dose: 2000 mg, 3 times / day
Route: oral
Route: multiple
Dose: 2000 mg, 3 times / day
Sources:
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
Other AEs: Neutropenia, Thrombocytopenia...
Other AEs:
Neutropenia (18%)
Thrombocytopenia (4%)
Anemia (severe, 4%)
Renal impairment (4%)
Sources:
50 mg/kg 3 times / day multiple, oral
Highest studied dose
Dose: 50 mg/kg, 3 times / day
Route: oral
Route: multiple
Dose: 50 mg/kg, 3 times / day
Sources:
unhealthy, 7.4 years (range: 0.5-16.9 years)
n = 36
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 7.4 years (range: 0.5-16.9 years)
Population Size: 36
Sources:
Other AEs: Neutropenia...
Other AEs:
Neutropenia (22%)
Sources:
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Other AEs: Fever, Infection...
Other AEs:
Fever (48%)
Infection (13%)
Chills (10%)
Sepsis (15%)
Diarrhea (44%)
Anorexia (14%)
Vomiting (13%)
Leukopenia (41%)
Anemia (25%)
Thrombocytopenia (6%)
Neuropathy (9%)
Sweating (12%)
Pruritus (5%)
Catheter infection (9%)
Catheter sepsis (8%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Neutropenia 18%
2000 mg 3 times / day multiple, oral
Highest studied dose
Dose: 2000 mg, 3 times / day
Route: oral
Route: multiple
Dose: 2000 mg, 3 times / day
Sources:
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
Renal impairment 4%
2000 mg 3 times / day multiple, oral
Highest studied dose
Dose: 2000 mg, 3 times / day
Route: oral
Route: multiple
Dose: 2000 mg, 3 times / day
Sources:
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
Thrombocytopenia 4%
2000 mg 3 times / day multiple, oral
Highest studied dose
Dose: 2000 mg, 3 times / day
Route: oral
Route: multiple
Dose: 2000 mg, 3 times / day
Sources:
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
Anemia severe, 4%
2000 mg 3 times / day multiple, oral
Highest studied dose
Dose: 2000 mg, 3 times / day
Route: oral
Route: multiple
Dose: 2000 mg, 3 times / day
Sources:
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
Neutropenia 22%
50 mg/kg 3 times / day multiple, oral
Highest studied dose
Dose: 50 mg/kg, 3 times / day
Route: oral
Route: multiple
Dose: 50 mg/kg, 3 times / day
Sources:
unhealthy, 7.4 years (range: 0.5-16.9 years)
n = 36
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 7.4 years (range: 0.5-16.9 years)
Population Size: 36
Sources:
Chills 10%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Sweating 12%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Infection 13%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Vomiting 13%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Anorexia 14%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Sepsis 15%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Anemia 25%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Leukopenia 41%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Diarrhea 44%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Fever 48%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Pruritus 5%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Thrombocytopenia 6%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Catheter sepsis 8%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Catheter infection 9%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
Neuropathy 9%
5 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 5 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 5 mg/kg, 1 times / day
Sources:
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
PubMed

PubMed

TitleDatePubMed
Design and SAR study of a novel class of nucleotide analogues as potent anti-HCMV agents.
1999 Apr-May
Selective activity of various antiviral compounds against HHV-7 infection.
1999 Aug
Ganciclovir-induced encephalopathy in a bone marrow transplant recipient.
1999 Aug
Phenotypic and genetic characterization of thymidine kinase from clinical strains of varicella-zoster virus resistant to acyclovir.
1999 Oct
Posttransplantation: emerging and future therapies.
2000
The cyclohexene ring system as a furanose mimic: synthesis and antiviral activity of both enantiomers of cyclohexenylguanine.
2000 Feb 24
In vitro activities of methylenecyclopropane analogues of nucleosides and their phosphoralaninate prodrugs against cytomegalovirus and other herpesvirus infections.
2000 Jun
Synthesis and antiviral evaluation of halogenated beta-D- and -L-erythrofuranosylbenzimidazoles.
2000 Jun 15
Indolocarbazoles exhibit strong antiviral activity against human cytomegalovirus and are potent inhibitors of the pUL97 protein kinase.
2000 Oct
Anti-(herpes simplex virus) activity of 4'-thio-2'-deoxyuridines: a biochemical investigation for viral and cellular target enzymes.
2000 Oct 15
Guanosine analogues as anti-herpesvirus agents.
2000 Oct-Dec
Naphthalene carboxamides as inhibitors of human cytomegalovirus DNA polymerase.
2000 Sep 18
Recent advances in imaging endogenous or transferred gene expression utilizing radionuclide technologies in living subjects: applications to breast cancer.
2001
[Cytomegalovirus rhombencephalomyelitis in an immunocompetent subject].
2001 Feb
Failure of cidofovir to reduce CMV-antigenemia in a child transplanted from a matched unrelated donor.
2001 Feb
Stimulation of intercellular communication of poor-communicating cells by gap-junction-competent cells enhances the HSV-TK/GCV bystander effect in vitro.
2001 Feb 15
Prophylactic antiviral therapy in CMV high-risk liver transplant recipients.
2001 Feb-Mar
Imaging in vivo herpes simplex virus thymidine kinase gene transfer to tumour-bearing rodents using positron emission tomography and.
2001 Jan
[Perspectives on postgenome medicine: Gene therapy for brain tumors].
2001 Jan
Cytomegalovirus hemorrhagic gastritis.
2001 Jan
Isolation and analysis of an aciclovir-resistant murine cytomegalovirus mutant.
2001 Jan
Ganciclovir-loaded albumin nanoparticles: characterization and in vitro release properties.
2001 Jan
Retrovector encoding a green fluorescent protein-herpes simplex virus thymidine kinase fusion protein serves as a versatile suicide/reporter for cell and gene therapy applications.
2001 Jan 1
Mutations conferring ganciclovir resistance in a cohort of patients with acquired immunodeficiency syndrome and cytomegalovirus retinitis.
2001 Jan 15
Human beta-herpesvirus interactions in solid organ transplant recipients.
2001 Jan 15
Cytomegalovirus colitis complicating ulcerative colitis in the steroid-naive patient.
2001 Mar
Prevalence of cytomegalovirus infection in severe refractory ulcerative and Crohn's colitis.
2001 Mar
The real danger of lamivudine-resistant hepatitis B virus infection in the immunocompromised host.
2001 Mar
High-dose intravitreal ganciclovir and foscarnet for cytomegalovirus retinitis.
2001 Mar
Frosted branch angiitis in a child with HIV infection.
2001 Mar
Expression of herpes simplex virus-thymidine kinase gene controlled by a promoter region of the midkine gene confers selective cytotoxicity to ganciclovir in human carcinoma cells.
2001 Mar 1
Preevaluation of clinical trial data: the case of preemptive cytomegalovirus therapy in patients with human immunodeficiency virus.
2001 Mar 1
Adenovirus-mediated gene therapy specific for small cell lung cancer cells using a Myc-Max binding motif.
2001 Mar 15
The Role of Antiviral Prophylaxis for the Prevention of Epstein-Barr Virus-Associated Posttransplant Lymphoproliferative Disease in Solid Organ Transplant Recipients: A Systematic Review.
2017 Mar
Patents

Sample Use Guides

In Vivo Use Guide
Curator's Comment: Ganciclovir can be used as ophthalmic gel 1 drop in the affected eye 5 times per day in patients with acute herpetic keratitis.
Unknown
Route of Administration: Unknown
In Vitro Use Guide
Curator's Comment: The median concentration of ganciclovir that inhibits CMV replication (IC50) in vitro (laboratory strains or clinical isolates) has ranged from 0.02 to 3.48 ug/mL.
Unknown
Substance Class Mixture
Created
by admin
on Fri Dec 15 15:54:37 GMT 2023
Edited
by admin
on Fri Dec 15 15:54:37 GMT 2023
Record UNII
4P3T9QF9NZ
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
VALGANCICLOVIR HYDROCHLORIDE
JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
USAN  
Official Name English
L-VALINE, 2-((2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9-YL)METHOXY)-3-HYDROXYPROPYL ESTER, MONOHYDROCHLORIDE
Common Name English
RO-107-9070/194
Code English
VALGANCICLOVIR HYDROCHLORIDE [VANDF]
Common Name English
VALGANCICLOVIR HCL
VANDF  
Common Name English
RS-79070-194
Code English
VALGANCICLOVIR HYDROCHLORIDE [JAN]
Common Name English
VALGANCICLOVIR HYDROCHLORIDE [USP-RS]
Common Name English
RO107-9070/194
Code English
VALGANCICLOVIR HYDROCHLORIDE [USP MONOGRAPH]
Common Name English
VALCYTE
Brand Name English
RS-079070-194
Code English
NSC-760349
Code English
VALGANCICLOVIR HYDROCHLORIDE [MI]
Common Name English
VALGANCICLOVIR HYDROCHLORIDE [ORANGE BOOK]
Common Name English
VALGANCICLOVIR HCL [VANDF]
Common Name English
Valganciclovir hydrochloride [WHO-DD]
Common Name English
VALGANCICLOVIR HYDROCHLORIDE [MART.]
Common Name English
VALGANCICLOVIR (AS HYDROCHLORIDE)
Common Name English
VALGANCICLOVIR HYDROCHLORIDE [USAN]
Common Name English
L-VALINE, ESTER WITH 9-((2-HYDROXY-1-(HYDROXYMETHYL)ETHOXY)METHYL)GUANINE, MONOHYDROCHLORIDE
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C29575
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
NCI_THESAURUS C1556
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
NCI_THESAURUS C281
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
Code System Code Type Description
NCI_THESAURUS
C66648
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
RS_ITEM_NUM
1708004
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
DAILYMED
4P3T9QF9NZ
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
ChEMBL
CHEMBL1201314
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
MERCK INDEX
m11363
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY Merck Index
FDA UNII
4P3T9QF9NZ
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
EPA CompTox
DTXSID9046784
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
DRUG BANK
DBSALT001459
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
CAS
175865-59-5
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
USAN
JJ-81
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
RXCUI
283815
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY RxNorm
PUBCHEM
135413534
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
NSC
760349
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
EVMPD
SUB16471MIG
Created by admin on Fri Dec 15 15:54:37 GMT 2023 , Edited by admin on Fri Dec 15 15:54:37 GMT 2023
PRIMARY
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