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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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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
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
No data
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
591 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—319830770225
CarcinomaD002277—C80.0259528544187
NeoplasmsD009369—C803628411782
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A15331222179
Breast neoplasmsD001943EFO_0003869C50122141335
Non-small-cell lung carcinomaD002289——41321120
Neuroendocrine tumorsD018358EFO_1001901D3A.83811619
Thyroid neoplasmsD013964EFO_0003841——6—129
Islet cell adenomaD007516EFO_0007331D13.7231129
Ovarian neoplasmsD010051EFO_0003893C56—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 neoplasmsD007680EFO_0003865C647336—1762
Lung neoplasmsD008175—C34.902212—126
Prostatic neoplasmsD011471—C615131—118
RecurrenceD012008——3121—217
Colorectal neoplasmsD015179——492—215
Pancreatic neoplasmsD010190EFO_0003860C25382—114
Liver neoplasmsD008113EFO_1001513C22.02102—214
Neoplasm metastasisD009362EFO_0009708—271—312
GlioblastomaD005909EFO_0000515—571——12
Stomach neoplasmsD013274EFO_0003897C16451—111
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder neoplasmsD001749—C67114———14
MelanomaD008545——312———13
SarcomaD012509——49———11
Transitional cell carcinomaD002295———10———10
AdenocarcinomaD000230——18———9
LeukemiaD007938—C9534——18
LymphomaD008223—C85.934——18
Myeloid leukemia acuteD015470—C92.043——17
Myeloid leukemiaD007951—C9243——17
Lymphoid leukemiaD007945—C9133——17
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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 neoplasmsD064129——1———12
Myeloproliferative disordersD009196—D47.12————2
Hodgkin diseaseD006689—C812————2
Myelodysplastic-myeloproliferative diseasesD054437——2————2
ThrombocytosisD013922—D75.832————2
Mantle-cell lymphomaD020522—C83.11———12
AnemiaD000740EFO_0004272D64.91————1
Wet macular degenerationD057135EFO_0004683—1————1
Hand-foot syndromeD060831EFO_1001893—1————1
Tongue neoplasmsD014062EFO_0003871C02.91————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————55
CardiotoxicityD066126EFO_1001482—————44
FatigueD005221—R53.83————44
Torsades de pointesD016171EFO_0005307I47.21————22
Mouth neoplasmsD009062EFO_0003868C06.9————22
Heart failureD006333EFO_0003144I50————22
Acute diseaseD000208——————11
Long qt syndromeD008133HP_0001657I45.81————11
DeliriumD003693—R41.0————11
Renal insufficiencyD051437—N19————11
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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
$
€
£
₣
Sutent – Pfizer
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38,470 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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49,939 adverse events reported
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