Valganciclovir
Valcyte, Valganciclovir (valganciclovir) is a small molecule pharmaceutical. Valganciclovir was first approved as Valcyte on 2001-03-29. It is used to treat aids-related opportunistic infections, cytomegalovirus infections, and cytomegalovirus retinitis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| eye diseases | D005128 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Valcyte, Valganciclovir (discontinued: Valganciclovir)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Valganciclovir hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VALCYTE | CHEPLAPHARM Arzneimittel | N-021304 RX | 2001-03-29 | 1 products, RLD, RS |
| VALCYTE | CHEPLAPHARM Arzneimittel | N-022257 RX | 2009-08-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| valcyte | New Drug Application | 2025-01-10 |
| valganciclovir | ANDA | 2025-03-19 |
| valganciclovir hydrochloride | ANDA | 2024-05-27 |
| valganciclovir hydrochloride for oral | ANDA | 2023-10-17 |
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
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HCPCS
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Clinical
Clinical Trials
129 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Valganciclovir |
| INN | valganciclovir |
| Description | Valganciclovir is the L-valinyl ester of ganciclovir, into which it is rapidly converted by intestinal and hepatic esterases. It is a synthetic analogue of 2'-deoxyguanosine. It has a role as a prodrug and an antiviral drug. It is a member of purines and a L-valyl ester. It is functionally related to a guanine and a ganciclovir. |
| Classification | Small molecule |
| Drug class | antivirals: antivirals (acyclovir type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)[C@H](N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21 |
Identifiers
| PDB | — |
| CAS-ID | 175865-60-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201314 |
| ChEBI ID | 63635 |
| PubChem CID | 135413535 |
| DrugBank | DB01610 |
| UNII ID | GCU97FKN3R (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Valganciclovir
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,934 documents
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Safety
Black-box Warning
Black-box warning for: Valcyte, Valganciclovir, Valganciclovir hydrochloride, Valganciclovir hydrochloride for oral
Adverse Events
Top Adverse Reactions
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9,121 adverse events reported
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