Sutent(sunitinib malate)
Sutent (sunitinib malate) is a small molecule pharmaceutical. Sunitinib malate 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. It is known to target proto-oncogene tyrosine-protein kinase receptor Ret, mast/stem cell growth factor receptor Kit, vascular endothelial growth factor receptor 2, receptor-type tyrosine-protein kinase FLT3, fibroblast growth factor receptor 1, platelet-derived growth factor receptor beta, and vascular endothelial growth factor receptor 3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
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 |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sunitinib malate | ANDA | 2022-03-16 |
| sutent | New Drug Application | 2022-12-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gastrointestinal stromal tumors | EFO_0000505 | D046152 | C49.A |
| neuroendocrine tumors | EFO_1001901 | D018358 | D3A.8 |
| pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
| renal cell carcinoma | EFO_0000376 | D002292 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
292 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 6 | 6 | 25 | 47 | 31 | 114 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 8 | 3 | 22 | 19 | 36 | 87 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 3 | — | 2 | 6 | 11 | 22 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | 1 | 2 | 3 | 6 | 7 | 18 |
| Healthy volunteers/patients | — | 7 | 1 | — | 1 | — | 9 | ||
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 1 | 3 | 4 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | 2 | 1 | 3 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | 1 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | 1 | 2 |
| Weight gain | D015430 | HP_0004324 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | 3 | 1 | — | 3 | 7 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | 1 | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | — | 1 |
| Cardiac surgical procedures | D006348 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | — | 1 | — | — | 2 | 3 |
| Pregnancy in diabetics | D011254 | O24.91 | — | 1 | — | — | 1 | 2 | |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | — | — | — | 1 |
| High-risk pregnancy | D018566 | — | 1 | — | — | — | 1 | ||
| Therapeutics | D013812 | — | 1 | — | — | — | 1 | ||
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | 1 | |
| Wounds and injuries | D014947 | T14.8 | 1 | 1 | — | — | — | 1 | |
| Pressure ulcer | D003668 | L89 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 6 | 6 | |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 2 | 2 | |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | 1 | 1 | |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | 1 | 1 | |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Fetal macrosomia | D005320 | — | — | — | — | 1 | 1 | ||
| Kidney transplantation | D016030 | — | — | — | — | 1 | 1 | ||
| Pregnancy complications | D011248 | — | — | — | — | 1 | 1 | ||
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
| Therapeutic equivalency | D013810 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SUNITINIB MALATE |
| 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.O=C(O)C[C@H](O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 557795-19-4 |
| RxCUI | 357977 |
| ChEMBL ID | CHEMBL1567 |
| ChEBI ID | — |
| PubChem CID | 5329102 |
| DrugBank | DB01268 |
| UNII ID | V99T50803M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
RET
RET
KIT
KIT
KDR
KDR
FLT3
FLT3
FGFR1
FGFR1
PDGFRB
PDGFRB
FLT4
FLT4
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC, RET51
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase receptor Ret
Protein synonyms
Cadherin family member 12, cadherin-related family member 16, Proto-oncogene c-Ret, rearranged during transfection, ret proto-oncogene (multiple endocrine neoplasia and medullary thyroid carcinoma 1, Hirschsprung disease), RET receptor tyrosine kinase
Uniprot ID
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
Variants
Clinical Variant
No data
Financial
Sutent - Pfizer
$
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Sunitinib malate , Sutent
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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