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 | 2024-01-11 |
| valganciclovir | ANDA | 2024-11-01 |
| 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
121 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 | 4 | 13 | 23 | 9 | 11 | 56 |
| Infections | D007239 | EFO_0000544 | — | 1 | 6 | 9 | 5 | 4 | 24 |
| Communicable diseases | D003141 | — | — | — | 3 | 8 | 3 | 1 | 15 |
| Kidney transplantation | D016030 | — | — | 2 | 3 | 4 | 2 | 1 | 10 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 4 | 1 | 1 | 7 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | — | 2 | — | 1 | — | 3 |
| Leukemia | D007938 | — | C95 | — | 1 | — | 1 | 1 | 3 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 1 | — | 1 | 1 | 3 |
| Lymphoid leukemia | D007945 | — | C91 | — | 1 | — | 1 | 1 | 3 |
| Viremia | D014766 | — | B34.9 | — | 1 | — | 1 | 1 | 3 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytomegalovirus | D003587 | — | — | — | 2 | 5 | — | 1 | 7 |
| Deafness | D003638 | EFO_0001063 | H91.9 | — | 3 | 3 | — | — | 5 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | — | 2 | 2 | — | — | 4 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | — | — | 2 | — | 1 | 3 |
| Retinitis | D012173 | — | H30.9 | — | — | 2 | — | 1 | 3 |
| Sensorineural hearing loss | D006319 | HP_0000407 | H90.5 | — | 1 | 2 | — | — | 3 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 2 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | 1 | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | 1 | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
Show 9 more
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 | 6 | — | — | 1 | 7 |
| Neoplasms | D009369 | — | C80 | 4 | 3 | — | — | — | 6 |
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | 2 | 6 | — | — | — | 6 |
| Lymphoma | D008223 | — | C85.9 | — | 4 | — | — | 1 | 5 |
| Carcinoma | D002277 | — | C80.0 | 4 | 2 | — | — | — | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | 2 | 4 |
| Human herpesvirus 8 | D019288 | — | — | — | 3 | — | — | — | 3 |
| Syndrome | D013577 | — | — | 1 | 2 | — | — | 1 | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 2 | — | — | 1 | 3 |
| Hiv | D006678 | — | — | — | 2 | — | — | — | 2 |
Show 24 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 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | — | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Adenoviridae infections | D000257 | EFO_1001259 | B34.0 | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 1 | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | — | — | 1 | 1 |
| Hematologic neoplasms | D019337 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | — | — | 1 | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | — | — | — | 1 | 1 |
Show 55 more
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) |
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Valganciclovir
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Trends
PubMed Central
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Additional graphs summarizing 6,213 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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8,449 adverse events reported
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