Valganciclovir
Valcyte (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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Trade Name
FDA
EMA
Valcyte (generic drugs available since 2014-11-04)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| valcyte | New Drug Application | 2023-04-21 |
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
HCPCS
No data
Clinical
Clinical Trials
88 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 | 3 | 6 | 11 | 5 | 5 | 27 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 3 | 1 | 1 | 5 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 1 | — | 1 | 1 | 3 | |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | 3 | |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | — | 1 | — | 1 | — | 2 |
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 | |
| Sensorineural hearing loss | D006319 | HP_0000407 | H90.5 | — | 1 | 2 | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 1 | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | 1 | — | — | 1 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | — | — | 1 | |
| Bone marrow transplantation | D016026 | — | — | 1 | — | — | 1 | ||
| Cytomegalovirus | D003587 | — | — | 1 | — | — | 1 | ||
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | 1 | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 4 | — | — | — | 4 |
| Kidney transplantation | D016030 | 2 | 2 | — | — | 1 | 3 | ||
| Lymphoma | D008223 | C85.9 | — | 2 | — | — | — | 2 | |
| Hiv | D006678 | O98.7 | — | 2 | — | — | — | 2 | |
| Human herpesvirus 8 | D019288 | — | 2 | — | — | — | 2 | ||
| Nasopharyngeal neoplasms | D009303 | 2 | 1 | — | — | — | 2 | ||
| Kidney diseases | D007674 | EFO_0003086 | N08 | 2 | 2 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | 1 | 2 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | — | 1 | — | — | 1 | 2 | |
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | — | 1 | — | — | 1 | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 1 | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | — | — | — | — | 1 | 1 | |
| Essential thrombocythemia | D013920 | D47.3 | — | — | — | — | 1 | 1 | |
| Polycythemia vera | D011087 | D45 | — | — | — | — | 1 | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | — | — | — | — | 1 | 1 | |
| Multiple myeloma | D009101 | C90.0 | — | — | — | — | 1 | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | — | — | — | 1 | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | — | — | 1 | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | — | — | — | — | 1 | 1 |
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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
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Valcyte
Adverse Events
Top Adverse Reactions
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751 adverse events reported
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