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Details

Stereochemistry ABSOLUTE
Molecular Formula C22H27FN4O2.C4H6O5
Molecular Weight 532.5622
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 1
Charge 0

SHOW SMILES / InChI
Structure of SUNITINIB MALATE

SMILES

CCN(CC)CCN=C(c1c(C)c(/C(/[H])=C\2/c3cc(ccc3N=C2O)F)[nH]c1C)O.C([C@@]([H])(C(=O)O)O)C(=O)O

InChI

InChIKey=LBWFXVZLPYTWQI-IPOVEDGCSA-N
InChI=1S/C22H27FN4O2.C4H6O5/c1-5-27(6-2)10-9-24-22(29)20-13(3)19(25-14(20)4)12-17-16-11-15(23)7-8-18(16)26-21(17)28;5-2(4(8)9)1-3(6)7/h7-8,11-12,25H,5-6,9-10H2,1-4H3,(H,24,29)(H,26,28);2,5H,1H2,(H,6,7)(H,8,9)/b17-12-;/t;2-/m.0/s1

HIDE SMILES / InChI

Molecular Formula C22H27FN4O2
Molecular Weight 398.4746
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 1
Optical Activity NONE

Molecular Formula C4H6O5
Molecular Weight 134.0876
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 1 / 1
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment:: description was created based on several sources, including https://www.drugbank.ca/drugs/DB01268 | http://reference.medscape.com/drug/sutent-sunitinib-342201 | https://www.drugs.com/cdi/sunitinib.html | https://www.ncbi.nlm.nih.gov/pubmed/25272897 | https://www.ncbi.nlm.nih.gov/pubmed/28413468

Sunitinib (marketed as Sutent by Pfizer, and previously known as SU11248) is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor that was approved by the FDA for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor. Sunitinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRa and PDGFRb), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony-stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). Sunitinib adverse events are considered somewhat manageable and the incidence of serious adverse events low. The most common adverse events associated with sunitinib therapy are fatigue, diarrhea, nausea, anorexia, hypertension, yellow skin discoloration, hand-foot skin reaction, and stomatitis. In the placebo-controlled Phase III GIST study, adverse events which occurred more often with sunitinib than placebo included diarrhea, anorexia, skin discoloration, mucositis/stomatitis, asthenia, altered taste, and constipation. Dose reductions were required in 50% of the patients studied in RCC in order to manage the significant toxicities of this agent.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
SUTENT

Approved Use

SUTENT is a kinase inhibitor indicated for the treatment of: Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1) Advanced renal cell carcinoma (RCC). (1.2) Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (1.3) 1.1 Gastrointestinal Stromal Tumor (GIST) SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma (RCC) SUTENT is indicated for the treatment of advanced renal cell carcinoma. 1.3 Advanced Pancreatic Neuroendocrine Tumors (pNET) SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Launch Date

1.13823357E12
Primary
SUTENT

Approved Use

SUTENT is a kinase inhibitor indicated for the treatment of: Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1) Advanced renal cell carcinoma (RCC). (1.2) Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (1.3) 1.1 Gastrointestinal Stromal Tumor (GIST) SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma (RCC) SUTENT is indicated for the treatment of advanced renal cell carcinoma. 1.3 Advanced Pancreatic Neuroendocrine Tumors (pNET) SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Launch Date

1.13823357E12
Primary
SUTENT

Approved Use

SUTENT is a kinase inhibitor indicated for the treatment of: Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1) Advanced renal cell carcinoma (RCC). (1.2) Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (1.3) 1.1 Gastrointestinal Stromal Tumor (GIST) SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. 1.2 Advanced Renal Cell Carcinoma (RCC) SUTENT is indicated for the treatment of advanced renal cell carcinoma. 1.3 Advanced Pancreatic Neuroendocrine Tumors (pNET) SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Launch Date

1.13823357E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
4.35 ng/mL
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
N-DESETHYL SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
51.1 ng/mL
37.5 mg 1 times / day steady-state, oral
dose: 37.5 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered: ERLOTINIB
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
21.9 ng/mL
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
21.3 ng/mL
15 mg/m² 1 times / day steady-state, oral
dose: 15 mg/m²
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: CHILD
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
559 ng × h/mL
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
N-DESETHYL SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1056 ng × h/mL
37.5 mg 1 times / day steady-state, oral
dose: 37.5 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered: ERLOTINIB
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
1369 ng × h/mL
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
791 ng × h/L
15 mg/m² 1 times / day steady-state, oral
dose: 15 mg/m²
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: CHILD
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
111 h
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
N-DESETHYL SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
63.8 h
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
22.7 h
15 mg/m² 1 times / day steady-state, oral
dose: 15 mg/m²
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: CHILD
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
10%
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
N-DESETHYL SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5%
50 mg 1 times / day multiple, oral
dose: 50 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
SUNITINIB plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5%
SUNITINIB plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Disc. AE: Thrombocytopenia, Fever...
AEs leading to
discontinuation/dose reduction:
Thrombocytopenia (1 patient)
Fever (1 patient)
Fatigue (1 patient)
Nausea (1 patient)
Vomiting (1 patient)
Sources:
25 mg 1 times / day steady, oral
Dose: 25 mg, 1 times / day
Route: oral
Route: steady
Dose: 25 mg, 1 times / day
Sources:
unhealthy, 74 years
n = 1
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 74 years
Sex: M
Population Size: 1
Sources:
Disc. AE: Fever...
AEs leading to
discontinuation/dose reduction:
Fever (1 patient)
Sources:
350 mg 1 times / day steady, oral
Highest studied dose
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
unhealthy
175 mg steady, oral
Studied dose
Dose: 175 mg
Route: oral
Route: steady
Dose: 175 mg
Sources:
unhealthy
Health Status: unhealthy
Condition: advanced solid tumors
Sources:
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy
n = 202
Disc. AE: Anemia, Liver failure...
AEs leading to
discontinuation/dose reduction:
Anemia (4 patients)
Liver failure (2 patients)
Metabolic disorder (3 patients)
Sources:
AEs

AEs

AESignificanceDosePopulation
Fatigue 1 patient
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Fever 1 patient
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Nausea 1 patient
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Thrombocytopenia 1 patient
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Vomiting 1 patient
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy, 52-77 years
n = 5
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 52-77 years
Sex: M+F
Population Size: 5
Sources:
Fever 1 patient
Disc. AE
25 mg 1 times / day steady, oral
Dose: 25 mg, 1 times / day
Route: oral
Route: steady
Dose: 25 mg, 1 times / day
Sources:
unhealthy, 74 years
n = 1
Health Status: unhealthy
Condition: Renal Cell Carcinoma
Age Group: 74 years
Sex: M
Population Size: 1
Sources:
Liver failure 2 patients
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy
n = 202
Metabolic disorder 3 patients
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy
n = 202
Anemia 4 patients
Disc. AE
50 mg 1 times / day steady, oral (starting)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
unhealthy
n = 202
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no
no
no
yes [IC50 39 uM]
yes [Ki 110 uM]
yes [Ki 140 uM]
yes [Ki 24 uM]
yes [Ki 28 uM]
yes [Ki 5.4 uM]
yes [Ki 54 uM]
yes [Ki >150 uM]
yes [Ki >150 uM]
yes [Ki >150 uM]
yes [Ki >150 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
minor
minor
minor
minor
moderate
no
no
no
no
no
yes
yes (co-administration study)
Comment: ketoconazole increased auc of sunitinib by 51%
Tox targets

Tox targets

PubMed

PubMed

TitleDatePubMed
Imatinib mesylate-induced acute hepatitis in a patient treated for gastrointestinal stromal tumour.
2006 Jul
Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial.
2006 Oct 14
Sunitinib versus interferon alfa in metastatic renal-cell carcinoma.
2007 Jan 11
Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma.
2008 Aug 1
Sensitization of ABCG2-overexpressing cells to conventional chemotherapeutic agent by sunitinib was associated with inhibiting the function of ABCG2.
2009 Jun 28
Novel agents for renal cell carcinoma require novel selection paradigms to optimise first-line therapy.
2009 May
Synthesis and structure-activity relationship of 6-arylureido-3-pyrrol-2-ylmethylideneindolin-2-one derivatives as potent receptor tyrosine kinase inhibitors.
2010 Jul 1
Activation state-dependent binding of small molecule kinase inhibitors: structural insights from biochemistry.
2010 Nov 24
Potent activity of ponatinib (AP24534) in models of FLT3-driven acute myeloid leukemia and other hematologic malignancies.
2011 Jun
Sunitinib improves chemotherapeutic efficacy and ameliorates cisplatin-induced nephrotoxicity in experimental animals.
2011 May
Use of human stem cell derived cardiomyocytes to examine sunitinib mediated cardiotoxicity and electrophysiological alterations.
2011 Nov 15
Comprehensive analysis of kinase inhibitor selectivity.
2011 Oct 30
Comprehensive assay of kinase catalytic activity reveals features of kinase inhibitor selectivity.
2011 Oct 30
Neutrophil-mediated experimental metastasis is enhanced by VEGFR inhibition in a zebrafish xenograft model.
2012 Aug
Modulation of Akt/mTOR signaling overcomes sunitinib resistance in renal and prostate cancer cells.
2012 Jul
HGF/c-Met pathway is one of the mediators of sunitinib-induced tumor cell type-dependent metastasis.
2012 Jul 1
Evaluation of subchronic toxicity of SIM010603, a potent inhibitor of receptor tyrosine kinase, after 28-day repeated oral administration in SD rats and beagle dogs.
2012 May
Activity-based kinase profiling of approved tyrosine kinase inhibitors.
2013 Feb
Sunitinib, a tyrosine kinase inhibitor, induces cytochrome P450 1A1 gene in human breast cancer MCF7 cells through ligand-independent aryl hydrocarbon receptor activation.
2013 May
Development of cardiac hypertrophy by sunitinib in vivo and in vitro rat cardiomyocytes is influenced by the aryl hydrocarbon receptor signaling pathway.
2014 Mar
Inflammatory and fibrotic processes are involved in the cardiotoxic effect of sunitinib: Protective role of L-carnitine.
2016 Jan 22
Patents

Sample Use Guides

GIST: 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off. pNET: 37.5 mg orally once daily, with or without food, continuously without a scheduled off-treatment period
Route of Administration: Oral
Cell viability assays following suni¬tinib treatment were performed using a cell counting kit 8 (CCK 8; Dojindo Molecular Technologies, Inc., Kumamoto, Japan). PC 3 and LNCaP cells were seeded in 96 well plates (1x104 cells/well) with culture medium supplemented with 10% FBS and were incubated at 37˚C in incubator with an atmosphere of 5% CO2 for 12 h to allow adherence. Cells were treated with 10 μl culture medium containing 0, 5, 10 or 20 μmol/l of sunitinib for 24 h. A total of 10 μl CCK 8 was added to the cells, following sunitinib treatment, and the cells were incubated for a further 2 h at 37˚C. A microplate reader was used to measure the absorbance of each well at 450 nm
Substance Class Chemical
Created
by admin
on Sat Jun 26 09:08:29 UTC 2021
Edited
by admin
on Sat Jun 26 09:08:29 UTC 2021
Record UNII
LVX8N1UT73
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SUNITINIB MALATE
JAN   MART.   MI   ORANGE BOOK   USAN   VANDF   WHO-DD  
USAN  
Official Name English
SUNITINIB MALATE [MART.]
Common Name English
SUNITINIB MALATE [ORANGE BOOK]
Common Name English
SUNITINIB MALATE [MI]
Common Name English
SUNITINIB L-MALATE
Common Name English
N-(2-DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE HYDROGEN (2S)-2-HYDROXYBUTANEDIOATE
Common Name English
SUNITINIB MALATE [WHO-DD]
Common Name English
BUTANEDIOIC ACID, 2-HYDROXY-, (2S)-, COMPD. WITH N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-1,2-DIHYDRO-2-OXO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE (1:1)
Systematic Name English
SU010398
Code English
SUNITINIB MALATE [USAN]
Common Name English
PHA-290940AD
Code English
SUNITINIB MALATE [JAN]
Common Name English
SUTENT
Brand Name English
SU-010398
Code English
BUTANEDIOIC ACID, HYDROXY-, (2S)-, COMPD. WITH N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-1,2-DIHYDRO-2-OXO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE (1:1)
Common Name English
SUNITINIB MALATE [VANDF]
Common Name English
SU-011248 L-MALATE SALT
Code English
SU011248 L-MALATE SALT
Code English
Classification Tree Code System Code
NCI_THESAURUS C129825
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
EMA ASSESSMENT REPORTS SUTENT (AUTHORIZED: CARCINOMA , RENAL CELL)
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
EMA ASSESSMENT REPORTS SUTENT (AUTHORIZED: GASTROINTESTINAL STROMAL TUMORS)
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
NCI_THESAURUS C1967
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
NCI_THESAURUS C1971
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
Code System Code Type Description
FDA UNII
LVX8N1UT73
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
CAS
341031-54-7
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
DRUG BANK
DBSALT000166
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
RXCUI
616275
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY RxNorm
NCI_THESAURUS
C26673
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
PUBCHEM
6456015
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
EVMPD
SUB22366
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
EU-Orphan Drug
EU/3/05/268(WITHDRAWN)
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2008 on request of the sponsor. On 10 March 2005, orphan designation (EU/3/05/268) was granted by the European Commission to Pfizer Limited, United Kingdom, for (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate for the treatment of renal cell carcinoma. (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate has been authorised in the EU as Sutent since 19 July 2006 for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC) after failure of interferon alfa or interleukin-2 therapy.
EU-Orphan Drug
EU/3/05/267(WITHDRAWN)
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2008 on request of the sponsor. On 10 March 2005, orphan designation (EU/3/05/267) was granted by the European Commission to Pfizer Limited, United Kingdom, for (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate for the treatment of malignant gastrointestinal stromal tumours. (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate has been authorised in the EU as Sutent since 19 July 2006.
EPA CompTox
341031-54-7
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
ChEMBL
CHEMBL535
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY
MERCK INDEX
M10399
Created by admin on Sat Jun 26 09:08:30 UTC 2021 , Edited by admin on Sat Jun 26 09:08:30 UTC 2021
PRIMARY Merck Index
Related Record Type Details
PARENT -> SALT/SOLVATE
PARENT -> SALT/SOLVATE
Related Record Type Details
ACTIVE MOIETY