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
Sunitinib, Sutent
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 |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sunitinib malate | ANDA | 2024-09-10 |
| sutent | New Drug Application | 2022-12-08 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
586 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 | — | 31 | 98 | 29 | 7 | 70 | 224 |
| Carcinoma | D002277 | — | C80.0 | 25 | 95 | 27 | 5 | 44 | 186 |
| Neoplasms | D009369 | — | C80 | 35 | 27 | 4 | 1 | 17 | 81 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 15 | 32 | 12 | 2 | 20 | 77 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 12 | 21 | 4 | 1 | 3 | 35 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 13 | 2 | 1 | 1 | 20 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 3 | 8 | 1 | 1 | 6 | 19 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 6 | — | 1 | 2 | 9 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | 2 | 3 | 1 | 1 | 2 | 9 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 7 | — | 1 | — | 8 |
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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 | 33 | 5 | — | 17 | 61 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 21 | 2 | — | 1 | 26 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 13 | 1 | — | 1 | 18 |
| Recurrence | D012008 | — | — | 3 | 12 | 1 | — | 2 | 17 |
| Colorectal neoplasms | D015179 | — | — | 4 | 9 | 2 | — | 2 | 15 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 8 | 2 | — | 1 | 14 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 10 | 2 | — | 2 | 14 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 7 | 1 | — | 3 | 12 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 7 | 1 | — | — | 12 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 5 | 1 | — | 1 | 11 |
Show 11 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 | 14 | — | — | — | 14 |
| Melanoma | D008545 | — | — | 3 | 12 | — | — | — | 13 |
| Sarcoma | D012509 | — | — | 4 | 9 | — | — | — | 11 |
| Transitional cell carcinoma | D002295 | — | — | — | 10 | — | — | — | 10 |
| Adenocarcinoma | D000230 | — | — | 1 | 8 | — | — | — | 9 |
| Leukemia | D007938 | — | C95 | 3 | 4 | — | — | 1 | 8 |
| Lymphoma | D008223 | — | C85.9 | 3 | 4 | — | — | 1 | 8 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | 1 | 7 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 3 | — | — | 1 | 7 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 3 | — | — | 1 | 7 |
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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 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | — | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 2 | — | — | — | — | 2 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 2 | — | — | — | — | 2 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | 2 | — | — | — | — | 2 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | — | — | — | 1 | 2 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | — | — | — | — | 1 |
| Wet macular degeneration | D057135 | EFO_0004683 | — | 1 | — | — | — | — | 1 |
| Hand-foot syndrome | D060831 | EFO_1001893 | — | 1 | — | — | — | — | 1 |
| Tongue neoplasms | D014062 | EFO_0003871 | C02.9 | 1 | — | — | — | — | 1 |
Show 46 more
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 | — | — | — | — | — | 4 | 4 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 4 | 4 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 2 | 2 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 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
Revenue by drug
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Sutent – Pfizer
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 36,497 documents
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Safety
Black-box Warning
Black-box warning for: Sunitinib malate, Sutent
Adverse Events
Top Adverse Reactions
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49,644 adverse events reported
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