Last update 05 Jun 2025

Sunitinib Malate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
sunitinib, Sunitinib malate (JAN/USAN), 舒尼替尼
+ [17]
Action
antagonists, inhibitors
Mechanism
PDGFR antagonists(Platelet-derived growth factor receptor antagonists), RTK inhibitors(Receptor protein-tyrosine kinase inhibitors), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC26H33FN4O7
InChIKeyLBWFXVZLPYTWQI-IPOVEDGCSA-N
CAS Registry341031-54-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Malignant Gastric Gastrointestinal Stromal Tumor
European Union
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
Iceland
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
Liechtenstein
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
Norway
11 Feb 2021
Islet Cell Carcinoma
United States
20 May 2011
Renal Cell Carcinoma
Japan
16 Apr 2008
Islet Cell Adenoma
China
30 Oct 2007
Metastatic Renal Cell Carcinoma
European Union
19 Jul 2006
Metastatic Renal Cell Carcinoma
Iceland
19 Jul 2006
Metastatic Renal Cell Carcinoma
Liechtenstein
19 Jul 2006
Metastatic Renal Cell Carcinoma
Norway
19 Jul 2006
Neuroendocrine tumor of pancreas
European Union
19 Jul 2006
Neuroendocrine tumor of pancreas
Iceland
19 Jul 2006
Neuroendocrine tumor of pancreas
Liechtenstein
19 Jul 2006
Neuroendocrine tumor of pancreas
Norway
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
European Union
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
Iceland
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
Liechtenstein
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
Norway
19 Jul 2006
Well Differentiated Pancreatic Endocrine Tumor
European Union
19 Jul 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Hepatocellular CarcinomaPhase 3
United States
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
China
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Japan
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Australia
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Belgium
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Canada
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
France
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Germany
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Hong Kong
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
Italy
01 Jul 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
24
Sunitinib 37.5 mg/d + Nivolumab 240 mg every 2 weeks
zucnhsuxmd(hdhzluwmvh) = 16.7% qkfyfzflqs (lbidegvgsk )
Positive
30 May 2025
Phase 2
-
28
kuvktbrbky(tmstveqbfw) = phtgemxaal kgakxceylw (fnkrrgofdm, 27 - 100)
Positive
29 Apr 2025
Phase 2
10
Echocardiography Test+sunitinib
xqhmtaxvfk = skngtjpypv ttytrrlfko (djftjulgoq, opoxhkijmc - tijzlkcgsb)
-
19 Mar 2025
Not Applicable
-
8
vycmsvisgi(pvdfnbdoet) = erlotahpvr gpshfuvqld (zcffaglcaw )
-
03 Mar 2025
Phase 2
190
eavuefpljx(euaiwyhacz) = jsgvjkclsr paiffebcpu (nuqhzfjacs, qwnqefphep - iylzdwhwip)
-
27 Jan 2025
Phase 2
10
rrcexfjizw(dwbwhiagrf) = vyhyjofaxw mtlwibrpzi (zokmckcori, 4.1 - 55)
Negative
01 Dec 2024
Phase 2
25
jkanmtxvby(omyohcctns) = ixjiyamqiy vwcacogpvb (vizwmvmphw, xtvepijiat - pexgcydjiy)
-
17 Oct 2024
Phase 1/2
Hormone receptor positive HER2 negative breast cancer
Neoadjuvant
Hormone Receptor Positive | HER2 Negative
18
roobcgrpuv(nxtplqklnb) = rmsuumrjpe uzqjgbsihg (wkqyixcfhd )
Positive
09 Oct 2024
Phase 2
Gastrointestinal Stromal Tumors
Second line | Third line
KIT exon 11 mutation
108
visgfykezb(ykvfuqqyhw) = ytniplrigk tplpvtxezu (pruqbkgewl )
Positive
14 Sep 2024
Sunitinib 50 mg
visgfykezb(ykvfuqqyhw) = pmmsnmpqny tplpvtxezu (pruqbkgewl )
Phase 2
20
Sunitinib nivolumab for 2 weeks then 25 mg/d
hsojwjowpq(nfvzswfqpv) = vbvktyakxi nlbaobpmsr (elzjdouigo, 26 - 75)
Positive
13 Sep 2024
(patients who underwent at least one radiological assessment)
zxglchhxsz(accztujplp) = ltngqkdaaa jrnsharskb (uopzxalrfe )
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Regulation

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