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

Description
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/monograph/valganciclovir-hydrochloride.html | http://www.rxlist.com/valcyte-drug/indications-dosage.htm

There is no information in the literature about pharmacological and biological application of definite isomer: R of valganciclovir. However, is known, that valganciclovir, existing, as a mixture of R and S diasteriomers, is the active ingredient in Valcyte, which is used as an antiviral medication given to patients who have a high chance of developing cytomegalovirus (CMV) disease after receiving a heart, kidney, or kidney-pancreas transplant. It was proposed, that stable aqueous solutions of valganciclovir can be prepared in aqueous solutions at acidic pHs but these solutions will exist as a mixture of isomers: R and S

CNS Activity

Originator

Approval Year

1989
121
Targets

Targets

Primary TargetPharmacologyConditionPotency
DNA polymerase catalytic subunit
12
Target ID: P08546
Gene ID: NA
Gene Symbol: UL54
Target Organism: Human cytomegalovirus (strain AD169) (HHV-5) (Human herpesvirus 5)
Antagonist
2760
Inhibitor
8228
 0.08 µM [EC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8360
ZIRGAN

Approved Use

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

Launch Date

8.1362878E11
Primary
Approved
8360
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

7.8805441E11
Primary
Approved
8360
VALCYTE

Approved Use

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

Launch Date

9.8573759E11
Primary
Approved
8360
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

9.8573759E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
4.8 mg/L
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/10747829
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
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/16737936
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
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/10747829
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
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/16737936
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
EXPERIMENT
https://www.ncbi.nlm.nih.gov/pubmed/16737936
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 37.4
n = 19
Health Status: unhealthy
Condition: AIDS
Age Group: 37.4
Population Size: 19
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
Other AEs: Neutropenia, Thrombocytopenia...
Other AEs:
Neutropenia (18%)
Thrombocytopenia (4%)
Anemia (severe, 4%)
Renal impairment (4%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/11069232/
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:
https://pubmed.ncbi.nlm.nih.gov/11069232/
Other AEs: Neutropenia...
Other AEs:
Neutropenia (22%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/11069232/
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/7769276/
unhealthy, 38.6
n = 50
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: 38.6
Population Size: 50
Sources:
https://pubmed.ncbi.nlm.nih.gov/7769276/
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:
https://pubmed.ncbi.nlm.nih.gov/11069232/
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:
https://pubmed.ncbi.nlm.nih.gov/11069232/
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
unhealthy, adult
n = 179
Health Status: unhealthy
Condition: CMV retinitis in HIV infection
Age Group: adult
Sex: M+F
Population Size: 179
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019661s030lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
supressor
9

OverviewOther

Other InhibitorOther SubstrateOther Inducer
MATE1
132

MATE2
94

OCT1
322

OAT1
320

OAT2
111

OAT3
333

OCT2
348

P-gp
1527

MRP4
75
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
OAT3
333
 no
OCT2
348
 no
MATE1
132
 yes
MATE2
94
 yes
MRP4
75
 yes
OAT1
320
 yes
OAT2
111
 yes
OCT1
322
 yes
P-gp
1527
 yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1632
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:465284
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:465284
ChemicalBook
CB6203364
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB6203364
MolPort
MolPort-000-758-398
https://www.molport.com/shop/molecule-link/MolPort-000-758-398
MolPort
MolPort-002-507-301
https://www.molport.com/shop/molecule-link/MolPort-002-507-301
MolPort
MolPort-006-167-681
https://www.molport.com/shop/molecule-link/MolPort-006-167-681
Selleck Chemicals
ganciclovir
http://www.selleckchem.com/products/ganciclovir.html
ZINC
ZINC000000001505
http://zinc15.docking.org/substances/ZINC000000001505
eMolecules
31410312
https://www.emolecules.com/cgi-bin/more?vid=31410312
eMolecules
538661
https://www.emolecules.com/cgi-bin/more?vid=538661
PubMed

PubMed

TitleDatePubMed
Hydroxyurea potentiates the antiherpesvirus activities of purine and pyrimidine nucleoside and nucleoside phosphonate analogs.
1999 Dec
Structure-activity relationships of L-dioxolane uracil nucleosides as anti-Epstein Barr virus agents.
1999 Jun 17
Comparative study of the anti-human cytomegalovirus activities and toxicities of a tetrahydrofuran phosphonate analogue of guanosine and cidofovir.
1999 Mar
Human cytomegalovirus: challenges, opportunities and new drug development.
1999 Sep
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
Antiviral activity of ganciclovir elaidic acid ester against herpesviruses.
2000 Mar
Anti-(herpes simplex virus) activity of 4'-thio-2'-deoxyuridines: a biochemical investigation for viral and cellular target enzymes.
2000 Oct 15
Suicide gene therapy for human oral squamous cell carcinoma cell lines with adeno-associated virus vector.
2001 Apr
Intravitreal pharmacokinetics and retinal concentrations of ganciclovir and foscarnet after intravitreal administration in rabbits.
2001 Apr
Risk for cytomegalovirus disease in patients receiving polymerase chain reaction-based preemptive antiviral therapy after allogeneic stem cell transplantation depends on transplantation modality.
2001 Apr 1
[Cytomegalovirus rhombencephalomyelitis in an immunocompetent subject].
2001 Feb
Effect of the complexation with cyclodextrins on the in vitro antiviral activity of ganciclovir against human cytomegalovirus.
2001 Feb
Genetic risks of antiviral nucleoside analogues--a survey.
2001 Feb
Mutation of Gln125 to Asn selectively abolishes the thymidylate kinase activity of herpes simplex virus type 1 thymidine kinase.
2001 Feb
Selective killing of human immunodeficiency virus-infected cells by targeted gene transfer and inducible gene expression using a recombinant human immunodeficiency virus vector.
2001 Feb 10
Ovarian epithelial cell lineage-specific gene expression using the promoter of a retrovirus-like element.
2001 Feb 15
Cytomegalovirus infection-enhanced chronic rejection in the rat is prevented by antiviral prophylaxis.
2001 Feb-Mar
Ganciclovir prophylaxis for cytomegalovirus infection in simultaneous kidney-pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and prednisone.
2001 Feb-Mar
[Gene therapy for colorectal cancer].
2001 Jan
Cytomegalovirus hemorrhagic gastritis.
2001 Jan
Cytomegalovirus infection and non-neutropenic fever after autologous stem cell transplantation: high rates of reactivation in patients with multiple myeloma and lymphoma.
2001 Jan
Isolation and analysis of an aciclovir-resistant murine cytomegalovirus mutant.
2001 Jan
Molecular mechanism for ganciclovir resistance in human T lymphocytes transduced with retroviral vectors carrying the herpes simplex virus thymidine kinase gene.
2001 Jan 1
Fatal primary infection due to human herpesvirus 6 variant A in a renal transplant recipient.
2001 Jan 27
Gene therapy for hepatocellular carcinoma using two recombinant adenovirus vectors with alpha-fetoprotein promoter and Cre/lox P system.
2001 Mar
Preevaluation of clinical trial data: the case of preemptive cytomegalovirus therapy in patients with human immunodeficiency virus.
2001 Mar 1
Patents

Patents

04355032
7
04609661
7
04803271
7
JP2000514093A
7
JP2002541233A
397
JP2004016051A
7
JP2007508039A
113
JP2011525180A
178
JP4733833B2
7
JP4758474B2
86
JPH0841061A
7
JPH0853452A
7
JPS57203086A
7
US20120121700 A1
7
US8586738 B2
7
US8889109 B2
7

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.
5 mg/kg every 12 hours (given intravenously at a constant rate over 1 hour) (induction treatment) and 5 mg/kg given as a constant-rate intravenous infusion over 1 hour once daily, 7 days per week, or 6 mg/kg once daily, 5 days per week (maintenance treatment).
Route of Administration: Intravenous
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.
IC50 is from 0.02 to 3.48 ug/mL
Substance Class Mixture
Created
by admin
on Wed Jul 05 23:23:03 UTC 2023
Edited
by admin
on Wed Jul 05 23:23:03 UTC 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 Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
NCI_THESAURUS C1556
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
NCI_THESAURUS C281
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
Code System Code Type Description
NCI_THESAURUS
C66648
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
RS_ITEM_NUM
1708004
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
DAILYMED
4P3T9QF9NZ
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
ChEMBL
CHEMBL1201314
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
MERCK INDEX
M11363
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY Merck Index
FDA UNII
4P3T9QF9NZ
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
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EPA CompTox
DTXSID9046784
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
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DRUG BANK
DBSALT001459
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
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CAS
175865-59-5
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
USAN
JJ-81
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
RXCUI
283815
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY RxNorm
PUBCHEM
135413534
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
NSC
760349
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
EVMPD
SUB16471MIG
Created by admin on Wed Jul 05 23:23:03 UTC 2023 , Edited by admin on Wed Jul 05 23:23:03 UTC 2023
PRIMARY
All of the following components must be present:
Structure of VALGANCICLOVIR HYDROCHLORIDE, (R)-
Structure of VALGANCICLOVIR HYDROCHLORIDE, (S)-
Related Record Type Details
VALGANCICLOVIR
PARENT -> SALT/SOLVATE
Related Record Type Details
Structure of GANCICLOVIR
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of 2-((2-AMINO-1,6-DIHYDRO-6-OXO-9H-PURIN-9-YL)METHOXY)-3-ACETOXY-1-PROPANOL
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of 2-(Methoxymethylamino)-1,7-dihydropurin-6-one
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of N-Methyl-L-valine 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of GUANINE
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of ISOVALGANCICLOVIR
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of 2-Amino-1,9-dihydro-9-(methoxymethyl)-6H-purin-6-one
IMPURITY -> PARENT
Structure of [2-[(2-Amino-6-oxo-1H-purin-9-yl)methoxymethoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Related Record Type Details
Structure of GANCICLOVIR
ACTIVE MOIETY
Definition References
NIH
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