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Drug ReportsGanciclovir
Cytovene, Vitrasert implant(ganciclovir)
Ganciclovir, Ganzyk-rtu, Vitrasert Implant, Zirgan (ganciclovir) is a small molecule pharmaceutical. Ganciclovir was first approved as Cytovene on 1989-06-23. It is used to treat aids-related opportunistic infections, cytomegalovirus infections, and cytomegalovirus retinitis in the USA. It has been approved in Europe to treat cytomegalovirus retinitis and HIV infections.
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
eye diseasesD005128
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Ganciclovir, Zirgan (discontinued: Cytovene, Ganciclovir, Ganzyk-rtu, Vitrasert)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ganciclovir
Tradename
Company
Number
Date
Products
ZIRGANBausch Health CompaniesN-022211 RX2009-09-15
1 products, RLD, RS
Show 3 discontinued
Ganciclovir sodium
Tradename
Company
Number
Date
Products
CYTOVENECHEPLAPHARM ArzneimittelN-019661 DISCN1989-06-23
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
ganciclovirANDA2025-02-07
ganciclovir sodiumANDA2025-01-02
zirganNew Drug Application2024-02-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cytomegalovirus infectionsEFO_0001062D003586B25
aids-related opportunistic infections—D017088—
cytomegalovirus retinitisEFO_1001302D017726—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ganciclovir, Ganzyk-Rtu, Exela Pharma
94865302034-09-02DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
— J05AB06: Ganciclovir
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AD: Antivirals, ophthalmologic
— S01AD09: Ganciclovir
HCPCS
Code
Description
J1570
Injection, ganciclovir sodium, 500 mg
J1574
Injection, ganciclovir sodium (exela) not therapeutically equivalent to j1570, 500 mg
J7310
Ganciclovir, 4.5 mg, long-acting implant
Level 3: J7310-J7310
Ganciclovir
Clinical
Clinical Trials
157 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cytomegalovirus infectionsD003586EFO_0001062B252113512
InfectionsD007239EFO_0000544—3——1711
Communicable diseasesD003141——1——146
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20412—1219
Cytomegalovirus retinitisD017726EFO_1001302—212—813
RetinitisD012173—H30.9212—813
Kidney transplantationD016030——111——2
Hematopoietic stem cell transplantationD018380————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal diseasesD005767——11———2
Digestive system diseasesD004066EFO_0000405K92.911———2
Kidney diseasesD007674EFO_0003086N0811———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ColitisD003092EFO_0003872K52.91———12
Cystic fibrosisD003550EFO_0000390E841————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B20————22
Immunologic deficiency syndromesD007153—D84.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGanciclovir
INNganciclovir
Description
Ganciclovir, sold under the brand name Cytovene among others, is an antiviral medication used to treat cytomegalovirus (CMV) infections.
Classification
Small molecule
Drug classantivirals: antivirals (acyclovir type)
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Structure (InChI/SMILES or Protein Sequence)
Nc1nc2c(ncn2COC(CO)CO)c(=O)[nH]1
Identifiers
PDB—
CAS-ID82410-32-0
RxCUI—
ChEMBL IDCHEMBL182
ChEBI ID465284
PubChem CID3454
DrugBankDB01004
UNII IDP9G3CKZ4P5 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Ganciclovir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,023 documents
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Safety
Black-box Warning
Black-box warning for: Ganciclovir, Ganciclovir sodium
Adverse Events
Top Adverse Reactions
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13,141 adverse events reported
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