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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Commercial
Therapeutic Areas
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
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZIRGAN | Bausch Health Companies | N-022211 RX | 2009-09-15 | 1 products, RLD, RS |
| GANZYK-RTU | Exela Pharma Sciences | N-209347 RX | 2017-02-17 | 1 products, RLD, RS |
Show 2 discontinued
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 | 2021-08-31 |
| 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 |
| 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
146 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 | 10 | 6 | 9 | 1 | 19 | 45 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 5 | 4 | 9 | 8 | 14 | 38 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | 7 | 6 | 8 | 1 | 14 | 36 |
| 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 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenoviridae | D000256 | — | — | — | 1 | 1 | — | — | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | 1 | — | — | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 2 | — | — | 2 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | — | 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 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 2 | — | — | — | 3 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | 1 | 3 |
| Human herpesvirus 8 | D019288 | — | — | — | 2 | — | — | — | 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 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | — | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | 2 | — | — | — | — | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | 1 | 2 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 1 | — | — | — | — | 1 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | — | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
| Malignant mesothelioma | D000086002 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
Show 10 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anterior uveitis | D014606 | EFO_1000811 | — | — | — | — | — | 2 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 2 | 2 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | — | — | 1 | 1 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 1 | 1 |
| Viral drug resistance | D024882 | — | — | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 1 | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 1 | 1 |
Show 44 more
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 | — |
| ChEMBL ID | CHEMBL182 |
| ChEBI ID | 465284 |
| PubChem CID | 3454 |
| DrugBank | DB01004 |
| UNII ID | P9G3CKZ4P5 (ChemIDplus, GSRS) |
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Ganciclovir
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Trends
PubMed Central
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Additional graphs summarizing 19,611 documents
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Safety
Black-box Warning
Black-box warning for: Ganciclovir
Adverse Events
Top Adverse Reactions
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8,557 adverse events reported
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