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Drug ReportsSunitinib malate
Sunitinib malate
Sunitinib, 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.
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Drug
Target
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Financial
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Safety
Events Timeline
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YTD
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2Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Sunitinib
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
sunitinib malateANDA2025-04-17
sutentNew Drug Application2025-03-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
renal cell carcinomaEFO_0000376D002292—
pancreatic neoplasmsEFO_0003860D010190C25
gastrointestinal stromal tumorsEFO_0000505D046152C49.A
neuroendocrine tumorsEFO_1001901D018358D3A.8
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX01: Sunitinib
HCPCS
No data
Clinical
Clinical Trials
592 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 carcinomaD002292EFO_0000376—624622865
CarcinomaD002277—C80.0522722257
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A2321815
Neuroendocrine tumorsD018358EFO_1001901D3A.8—5—139
Islet cell adenomaD007516EFO_0007331D13.7—31127
Gastrointestinal neoplasmsD005770—C26.9———123
Digestive system neoplasmsD004067—————123
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C508104—220
Lung neoplasmsD008175—C34.90291—113
Kidney neoplasmsD007680EFO_0003865C64171—312
Non-small-cell lung carcinomaD002289——361—111
Prostatic neoplasmsD011471—C61371——10
Colorectal neoplasmsD015179——241——7
Hepatocellular carcinomaD006528—C22.0121—15
Liver neoplasmsD008113EFO_1001513C22.0121—15
Pancreatic neoplasmsD010190EFO_0003860C25—21——3
Islet cell carcinomaD018273—C25.4——1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80158——426
MelanomaD008545——37———8
Urinary bladder neoplasmsD001749—C67—7———7
GlioblastomaD005909EFO_0000515—33———6
Stomach neoplasmsD013274EFO_0003897C1641——16
Transitional cell carcinomaD002295———5———5
Neoplasm metastasisD009362EFO_0009708——3——14
Esophageal neoplasmsD004938—C1513———4
Thyroid neoplasmsD013964EFO_0003841——2——13
Non-hodgkin lymphomaD008228—C85.9—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Clear cell sarcomaD018227——1————1
Head and neck neoplasmsD006258——1————1
Thoracic neoplasmsD013899——1————1
Nervous system neoplasmsD009423——1————1
Pelvic neoplasmsD010386——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9————11
Mantle-cell lymphomaD020522—C83.1————11
Castration-resistant prostatic neoplasmsD064129——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSunitinib malate
INNsunitinib
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 classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
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-ID557795-19-4
RxCUI357977
ChEMBL IDCHEMBL1567
ChEBI ID—
PubChem CID5329102
DrugBankDB01268
UNII IDV99T50803M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Sutent – Pfizer
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,758 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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50,256 adverse events reported
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