Cytovene, Vitrasert implant(ganciclovir)
Cytovene, 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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Ganzyk-rtu, Zirgan (generic drugs available since 2003-07-16, discontinued: Cytovene, Vitrasert)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ganciclovir
Ganciclovir sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CYTOVENE | CHEPLAPHARM Arzneimittel | N-019661 DISCN | 1989-06-23 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ganciclovir | ANDA | 2022-12-21 |
| zirgan | New Drug Application | 2019-09-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| aids-related opportunistic infections | — | D017088 | — |
| cytomegalovirus infections | EFO_0001062 | D003586 | B25 |
| cytomegalovirus retinitis | EFO_1001302 | D017726 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ganciclovir, Ganzyk-Rtu, Exela Pharma | |||
| 9486530 | 2034-09-02 | DP | |
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 |
| J7310 | Ganciclovir, 4.5 mg, long-acting implant |
| Level 3: J7310-J7310 | Ganciclovir |
Clinical
Clinical Trials
100 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 8 | 4 | 7 | 1 | 17 | 37 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | 4 | 4 | 7 | 1 | 12 | 28 | |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 4 | 2 | 6 | 6 | 9 | 25 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | 2 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | 1 | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | 1 | — | 1 |
| Keratoconjunctivitis | D007637 | H16.2 | — | — | — | 1 | — | 1 | |
| Virus shedding | D017201 | — | — | — | 1 | — | 1 | ||
| Viremia | D014766 | B34.9 | — | — | — | 1 | — | 1 | |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | 1 | — | — | 2 |
| Conjunctivitis | D003231 | H10 | — | — | 1 | — | — | 1 | |
| Adenoviridae | D000256 | — | — | 1 | — | — | 1 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 2 | 3 | — | — | 1 | 6 | |
| Leukemia | D007938 | C95 | 1 | 1 | — | — | 1 | 3 | |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 1 | — | — | — | 2 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 2 | 1 | — | — | — | 2 |
| Multiple myeloma | D009101 | C90.0 | — | 1 | — | — | 1 | 2 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Kidney transplantation | D016030 | 1 | 1 | — | — | — | 1 | ||
| Graft vs host disease | D006086 | D89.81 | — | 1 | — | — | — | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | 1 | 2 |
| Neuroblastoma | D009447 | EFO_0000621 | 1 | — | — | — | — | 1 | |
| Precancerous conditions | D011230 | 1 | — | — | — | — | 1 | ||
| Malignant mesothelioma | D000086002 | 1 | — | — | — | — | 1 | ||
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| Central nervous system neoplasms | D016543 | 1 | — | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | — | — | — | — | 1 | |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 1 | — | — | — | — | 1 |
| Radiculopathy | D011843 | M54.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 2 | 2 | |
| Cerebral hemorrhage | D002543 | — | — | — | — | 1 | 1 | ||
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | 1 | 1 | ||
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Virus diseases | D014777 | B34 | — | — | — | — | 1 | 1 | |
| Posterior uveitis | D015866 | EFO_1001119 | — | — | — | — | 1 | 1 | |
| Herpetic keratitis | D016849 | EFO_0007308 | — | — | — | — | 1 | 1 | |
| Anterior uveitis | D014606 | EFO_1000811 | — | — | — | — | 1 | 1 | |
| Viral conjunctivitis | D003236 | EFO_0008571 | B30 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GANCICLOVIR |
| INN | ganciclovir |
| Description | Ganciclovir, sold under the brand name Cytovene among others, is an antiviral medication used to treat cytomegalovirus (CMV) infections.
|
| Classification | Small molecule |
| Drug class | antivirals: antivirals (acyclovir type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc2c(ncn2COC(CO)CO)c(=O)[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 82410-32-0 |
| RxCUI | 4678 |
| ChEMBL ID | CHEMBL182 |
| ChEBI ID | 465284 |
| PubChem CID | 3454 |
| DrugBank | DB01004 |
| UNII ID | P9G3CKZ4P5 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,823 documents
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Safety
Black-box Warning
Black-box warning for: Ganciclovir
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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