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
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 |
|---|---|---|---|---|
| ZIRGAN | Bausch Health Companies | N-022211 RX | 2009-09-15 | 1 products, RLD, RS |
Show 3 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 | 2025-02-07 |
| ganciclovir sodium | ANDA | 2025-01-02 |
| zirgan | New Drug Application | 2024-02-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cytomegalovirus infections | EFO_0001062 | D003586 | B25 |
| aids-related opportunistic infections | — | D017088 | — |
| 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
220 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 infections | D003586 | EFO_0001062 | B25 | 8 | 19 | 28 | 13 | 24 | 87 |
| Infections | D007239 | EFO_0000544 | — | 8 | 10 | 13 | 7 | 20 | 56 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 10 | 9 | 11 | 2 | 19 | 50 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | 7 | 6 | 9 | 1 | 14 | 37 |
| Retinitis | D012173 | — | H30.9 | 7 | 6 | 9 | 1 | 14 | 37 |
| Communicable diseases | D003141 | — | — | 3 | 4 | 10 | 5 | 9 | 30 |
| Kidney transplantation | D016030 | — | — | 1 | 2 | 3 | 2 | 1 | 8 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 2 | 1 | 2 | 7 |
| Viremia | D014766 | — | B34.9 | — | 4 | 1 | 1 | 2 | 7 |
| Leukemia | D007938 | — | C95 | 1 | 2 | — | 1 | 2 | 6 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytomegalovirus | D003587 | — | — | — | 2 | 6 | — | 2 | 9 |
| Deafness | D003638 | EFO_0001063 | H91.9 | — | 3 | 3 | — | — | 5 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | — | 2 | 2 | — | — | 4 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 2 | — | 1 | 3 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | 1 | — | 1 | 3 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | 2 | — | 1 | 3 |
| Sensorineural hearing loss | D006319 | — | H90.5 | — | 1 | 2 | — | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | 1 | — | — | 2 |
| Adenoviridae | D000256 | — | — | — | 1 | 1 | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 1 | — | — | 2 |
Show 10 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 3 | 7 | — | — | 2 | 11 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 2 | 6 | — | — | 1 | 8 |
| Neoplasms | D009369 | — | C80 | 4 | 2 | — | — | 1 | 7 |
| Keratitis | D007634 | — | H16 | 1 | 2 | — | — | 3 | 6 |
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | 2 | 6 | — | — | — | 6 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | — | — | — | 4 |
| Herpes simplex | D006561 | — | B00 | 1 | 2 | — | — | 1 | 4 |
| Human herpesvirus 8 | D019288 | — | — | — | 3 | — | — | — | 3 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 2 | 1 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | 1 | 3 |
Show 35 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 |
| Nasopharyngeal neoplasms | D009303 | — | — | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | 2 | — | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
Show 20 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 2 | 2 |
| Viral drug resistance | D024882 | — | — | — | — | — | — | 2 | 2 |
| Herpetic keratitis | D016849 | EFO_0007308 | — | — | — | — | — | 2 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 2 | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | — | — | — | 2 | 2 |
| Preleukemia | D011289 | — | — | — | — | — | — | 2 | 2 |
| Plasmacytoma | D010954 | — | C90.3 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
Show 64 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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Financial
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Ganciclovir
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Trends
PubMed Central
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Additional graphs summarizing 21,353 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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13,538 adverse events reported
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