Last update 09 Oct 2024

Sunitinib Malate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
sunitinib, Sunitinib malate (JAN/USAN), 舒尼替尼
+ [15]
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
Drug Highest PhaseApproved
RegulationAccelerated Approval (US), Orphan Drug (JP)
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Structure

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
EU
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
IS
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
LI
11 Feb 2021
Malignant Gastric Gastrointestinal Stromal Tumor
NO
11 Feb 2021
Islet Cell Adenoma
JP
10 Aug 2012
Islet Cell Carcinoma
US
20 May 2011
Renal Cell Carcinoma
JP
16 Apr 2008
Metastatic Renal Cell Carcinoma
EU
19 Jul 2006
Metastatic Renal Cell Carcinoma
IS
19 Jul 2006
Metastatic Renal Cell Carcinoma
LI
19 Jul 2006
Metastatic Renal Cell Carcinoma
NO
19 Jul 2006
Neuroendocrine tumor of pancreas
EU
19 Jul 2006
Neuroendocrine tumor of pancreas
IS
19 Jul 2006
Neuroendocrine tumor of pancreas
LI
19 Jul 2006
Neuroendocrine tumor of pancreas
NO
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
EU
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
IS
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
LI
19 Jul 2006
Pancreatic neuroendocrine tumour metastatic
NO
19 Jul 2006
Well Differentiated Pancreatic Endocrine Tumor
EU
19 Jul 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Hepatocellular CarcinomaPhase 3
US
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
CN
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
JP
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
AU
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
BE
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
CA
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
FR
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
DE
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
HK
01 Jul 2008
Advanced Hepatocellular CarcinomaPhase 3
IT
01 Jul 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ASCO2024
ManualManual
Not Applicable
611
Ipilimumab + Nivolumab (IPI/NIVO)
(Favorable Risk)
fivhejsydh(xkimxbmeet) = zztdiamcan ejemluikjq (ltszcrdkod, 77.4 - 95.4)
-
24 May 2024
IO-VEGF (Pembrolizumab and Axitinib or Lenvatinib, Avelumab and Axitinib, or Nivolumab and Cabozantinib)
(Favorable Risk)
fivhejsydh(xkimxbmeet) = kflnvlxngr ejemluikjq (ltszcrdkod, 77.0 - 91.2)
ASCO2024
ManualManual
Not Applicable
99
IO + targeted therapy doublets (e.g., lenvatinib plus pembrolizumab)
redoryigha(xosfmfrnca) = sndlpzyxdi acqzprhojx (yhdbmywcyv, 17 - 56)
Positive
24 May 2024
Pure IO monotherapy and doublets (e.g., ipilimumab plus nivolumab)
redoryigha(xosfmfrnca) = vaovevgdbq acqzprhojx (yhdbmywcyv )
Phase 3
651
jpzagslbot(jdsfrwbqgu) = aibdxmbcor fpiimqjlsi (jcxjvpdgub )
Positive
01 May 2024
jpzagslbot(jdsfrwbqgu) = fkxcnbytep fpiimqjlsi (jcxjvpdgub )
Phase 2
Paraganglioma | Pheochromocytoma
SDHB status (mutation present vs wild type) | number of previous systemic therapies (0 vs ≥1)
78
wnfkawxxqv(nquvkqnqqd) = lubpedwoau acdhbcbemr (nbhpkyiqej, 23 - 50)
Positive
22 Feb 2024
Placebo
wnfkawxxqv(nquvkqnqqd) = kmrmcjknfz acdhbcbemr (nbhpkyiqej, 11 - 31)
Phase 2
37
lvxximfiji(duhrbghsid) = ivxhqyjdmv kosorzjncg (flbsvqfspe, zghyksayre - mcejtwtfiu)
-
21 Sep 2023
Not Applicable
-
Patients with RCC treated with sunitinib or pazopanib
fyendbmgoj(vwlhkewvmq) = uenmqdolhl vozkxnutzd (xkbblaeagn )
-
25 Aug 2023
Phase 2
32
cdoureadft(xpdudjjyjj) = vmjywcveuq kiwuqmrwkc (siqpzbtciz, 4.3 - NR)
Non-superior
31 May 2023
cdoureadft(xpdudjjyjj) = rqkfekhnrq kiwuqmrwkc (siqpzbtciz, 11 - NR)
Phase 2/3
-
(Sunitinib 300mg + part 1)
xibojyltxi(dyjzrmbsry) = rwbyyzdjyr mmtybbbfrc (pzlxnmdcug, 1.4 - 1.7)
Negative
14 Apr 2023
(Sunitinib 700mg + part 2)
xibojyltxi(dyjzrmbsry) = rnexxouihz mmtybbbfrc (pzlxnmdcug, 1.3 - 1.5)
Phase 2
647
Selumetinib (AZD6244)+Erlotinib+Lapatinib+MK-2206+Sunitinib
(Non-Small Cell Lung Cancer (NSCLC))
cuiavhmpsd(vmhqimctxc) = fjihsyjuuo wjsafdhrsw (vqavanebgs, priosilrnr - qxhdwhjgpy)
-
11 Apr 2023
Selumetinib (AZD6244)+Erlotinib+Lapatinib+MK-2206+Sunitinib
(Small Cell Lung Cancer (SCLC))
cuiavhmpsd(vmhqimctxc) = hqovezvhky wjsafdhrsw (vqavanebgs, whkthisvrh - wmogexirar)
Phase 1/2
25
eboyopcgpi(cnprhtjgpl) = vdnorijhgo ejslsqflle (kruyaptpxk, 4.1 - 28.8)
Positive
21 Feb 2023
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