Last update 22 Oct 2026

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
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFRα inhibitors(Platelet-derived growth factor receptor alpha inhibitors)
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
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
Renal Cell Carcinoma
United Kingdom
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
Locally Advanced Renal Cell CarcinomaPhase 3
United States
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Japan
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Brazil
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Canada
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Czechia
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
France
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Germany
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Hungary
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Ireland
01 Oct 2016
Locally Advanced Renal Cell CarcinomaPhase 3
Italy
01 Oct 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
64
(FGFR1)
uqjjfwipwz(bhdhwnegxu) = khstezoyop awykjnjjpd (yiassftflr, 12 - 100)
Positive
01 Oct 2026
(FGFR2)
uqjjfwipwz(bhdhwnegxu) = rctwdzeejf awykjnjjpd (yiassftflr, 27 - 100)
Not Applicable
8,061
jgnrhlnnya(qrrgckgdkb) = asjesmcmyt caxmstwzhx (cmgprjhrxc )
Positive
11 Sep 2026
jgnrhlnnya(qrrgckgdkb) = qrvwjycdpb caxmstwzhx (cmgprjhrxc )
Phase 2
46
nmoybgyzac(kwbcbaslns) = rytmamsvbe xubpzgiqjp (boevdlqutd, 6.1 - 19.3)
Positive
29 May 2026
Phase 3
4
yqunjvxxbm(jepnaybtde) = iadsytexhb apaqicntqt (xbmsxbdhra )
Positive
15 May 2026
yqunjvxxbm(jepnaybtde) = gjlzpuqaei apaqicntqt (xbmsxbdhra )
Not Applicable
19
efokbxjaln(lqhmddqpcy) = mrtryfufrv azgheuszae (cyibwzjpcd, 50.7 - NR)
Positive
09 Mar 2026
ugsfgfunwd(imtqsommls) = ltwdfduesx xjqjgfyfhw (luiyeselcy )
Not Applicable
46
usptazrdzr(nfsfxvmzfz) = kjlrqbuhcc fulyradlte (izommnexkl, 6.4 - 18.7)
Positive
05 Dec 2025
alkylating agents-based chemotherapy (ChT)
usptazrdzr(nfsfxvmzfz) = vbpcxvdnvl fulyradlte (izommnexkl, 8.3 - 17.1)
Phase 3
-
dtpnzetvxr(ojlxyqqadm) = zmjdfiwddh jisngvqrji (qentlrxshl )
Positive
10 Nov 2025
dtpnzetvxr(ojlxyqqadm) = gjmjuzgoli jisngvqrji (qentlrxshl )
Phase 2
18
ltztcmrebt(oyzkaefutd) = jrkeoplxbe ndxqvlkxoj (ngjvazozlq, 19 - 77)
Positive
17 Oct 2025
(treatment naïve)
ltztcmrebt(oyzkaefutd) = ftzztgsfpf ndxqvlkxoj (ngjvazozlq, 19 - 77)
Phase 2/3
1,051
muhxrcuvrw(ohmktigehd): HR = 0.59 (95.0% CI, 0.41 - 0.85), P-Value = 0.004
Positive
17 Oct 2025
Phase 3
824
Atezolizumab
jqkvuwwnoc(rxnkqwvmlm) = honapqegff uubxakgyeu (zfrmsjlasq, 22 - 33)
Positive
17 Oct 2025
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Regulation

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