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 |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 1 | 3 | 1 | 12 | 21 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 3 | 2 | 4 | 5 | 6 | 19 |
| Infections | D007239 | EFO_0000544 | — | 3 | — | 1 | 2 | 8 | 14 |
| Communicable diseases | D003141 | — | — | 1 | — | — | 2 | 4 | 7 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | 1 | 2 | 3 |
| Kidney transplantation | D016030 | — | — | 1 | 1 | 1 | 1 | — | 3 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | — | — | 1 | — | 1 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | — | — | — | 1 | — | 1 |
| Lymphadenopathy | D000072281 | — | R59.1 | — | — | — | 1 | — | 1 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | 2 | 1 | 3 | — | 8 | 14 |
| Retinitis | D012173 | — | H30.9 | 2 | 1 | 3 | — | 8 | 14 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal diseases | D005767 | — | — | 1 | 1 | — | — | — | 2 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 1 | 1 | — | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | 1 | — | — | — | 1 |
| Human herpesvirus 8 | D019288 | — | — | — | 1 | — | — | — | 1 |
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 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 1 | 1 |
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) |
Target
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Variants
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Financial
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Estimated US medical usage
Ganciclovir
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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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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