Sutent(sunitinib)
Sunitinib, Sutent (sunitinib) is a small molecule pharmaceutical. Sunitinib was first approved as Sutent on 2006-01-26. It is used to treat gastrointestinal stromal tumors, neuroendocrine tumors, pancreatic neoplasms, and renal cell carcinoma in the USA. It has been approved in Europe to treat gastrointestinal stromal tumors, neuroendocrine tumors, and renal cell carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 3, mast/stem cell growth factor receptor Kit, and platelet-derived growth factor receptor beta. In addition, it is known to target fibroblast growth factor receptor 1, proto-oncogene tyrosine-protein kinase receptor Ret, receptor-type tyrosine-protein kinase FLT3, and vascular endothelial growth factor receptor 2.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Sutent (generic drugs available since 2021-08-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sunitinib malate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUTENT | CP Pharmaceuticals International CV | N-021938 RX | 2006-01-26 | 4 products, RLD, RS |
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FDA
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Indications
FDA
EMA
Agency Specific
FDA
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Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
585 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 28 | 78 | 27 | 7 | 58 | 188 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 12 | 30 | 12 | 2 | 17 | 70 |
| Neoplasms | D009369 | — | C80 | 29 | 19 | 3 | 1 | 16 | 65 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 12 | 2 | 1 | 1 | 19 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 2 | 7 | 1 | 1 | 4 | 15 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 7 | 24 | 4 | — | 17 | 51 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 12 | 20 | 4 | — | 3 | 33 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 12 | 1 | — | — | 16 |
| Colorectal neoplasms | D015179 | — | — | 4 | 9 | 2 | — | 1 | 14 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 7 | 1 | — | 1 | 12 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 7 | 1 | — | — | 12 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 9 | 2 | — | 1 | 12 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | 4 | 1 | — | — | 6 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | 1 | — | 1 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | 1 | — | 1 | 3 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 13 | — | — | — | 13 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 5 | — | — | 1 | 10 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 6 | — | — | 2 | 8 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | 1 | 7 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 7 | — | — | — | 7 |
| Melanoma | D008545 | — | — | 3 | 6 | — | — | — | 7 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 5 | — | — | 2 | 7 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 3 | 2 | — | — | 1 | 6 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 4 | — | — | — | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 6 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | 1 | 2 |
| Hodgkin disease | D006689 | — | C81 | 2 | — | — | — | — | 2 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | — | — | — | 1 | 2 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | — | — | — | — | 1 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | 1 | — | — | — | — | 1 |
| Hand-foot syndrome | D060831 | EFO_1001893 | — | 1 | — | — | — | — | 1 |
| Tongue neoplasms | D014062 | EFO_0003871 | C02.9 | 1 | — | — | — | — | 1 |
| Verrucous carcinoma | D018289 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 5 | 5 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | — | — | 3 | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 3 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Oral administration | D000284 | — | — | — | — | — | — | 1 | 1 |
| Gene expression | D015870 | — | — | — | — | — | — | 1 | 1 |
| Molecular targeted therapy | D058990 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sunitinib |
| INN | sunitinib |
| Description | Sunitinib is a member of pyrroles and a monocarboxylic acid amide. It has a role as an angiogenesis inhibitor, an antineoplastic agent, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor, a vascular endothelial growth factor receptor antagonist, an immunomodulator and a neuroprotective agent. It is functionally related to a 3-methyleneoxindole. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C |
Identifiers
| PDB | — |
| CAS-ID | 557795-19-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL535 |
| ChEBI ID | 38940 |
| PubChem CID | 5329102 |
| DrugBank | DB01268 |
| UNII ID | V99T50803M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FGFR1
FGFR1
Organism
Homo sapiens
Gene name
FGFR1
Gene synonyms
BFGFR, CEK, FGFBR, FLG, FLT2, HBGFR
NCBI Gene ID
Protein name
fibroblast growth factor receptor 1
Protein synonyms
Basic fibroblast growth factor receptor 1, bFGF-R-1, BFGFR, CD331, FGFR1/PLAG1 fusion, FLT-2, FMS-like tyrosine kinase 2, fms-related tyrosine kinase 2, heparin-binding growth factor receptor, hydroxyaryl-protein kinase, N-sam, Proto-oncogene c-Fgr
Uniprot ID
Mouse ortholog
Fgfr1 (14182)
fibroblast growth factor receptor 1 (P16092)
Variants
No data
Financial
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Sutent – Pfizer
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 34,692 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,122 adverse events reported
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