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 | 2026-01-09 |
| ganciclovir sodium | ANDA | 2025-01-02 |
| zirgan | New Drug Application | 2026-02-05 |
Indications
FDA
EMA
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
225 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | — | 1 | — | 1 |
| Conjunctivitis | D003231 | — | H10 | — | — | — | 1 | — | 1 |
| Adenoviridae infections | D000257 | EFO_1001259 | B34.0 | — | — | — | 1 | — | 1 |
| Virus shedding | D017201 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratitis | D007634 | — | H16 | — | 1 | — | — | — | 1 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | 1 | — | — | — | 1 |
| Herpes simplex | D006561 | — | B00 | — | 1 | — | — | — | 1 |
| Herpes zoster ophthalmicus | D006563 | EFO_0007403 | B02.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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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 | — |
| 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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 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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13,904 adverse events reported
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