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Inlyta(axitinib)
Inlyta (axitinib) is a small molecule pharmaceutical. Axitinib was first approved as Inlyta on 2012-01-27. It is used to treat renal cell carcinoma in the USA. It has been approved in Europe to treat renal cell carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 2. In addition, it is known to target serine/threonine-protein kinase PLK4.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Inlyta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Axitinib
Tradename
Company
Number
Date
Products
INLYTACV SciencesN-202324 RX2012-01-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
inlytaNew Drug Application2022-12-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
renal cell carcinomaEFO_0000376D002292
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Axitinib, Inlyta, Pf Prism Cv
108699242037-01-12U-3044
105702022035-02-03U-2844
87911402030-12-14DP
65345242025-04-29DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EK: Vascular endothelial growth factor receptor (vegfr) tyrosine kinase inhibitors
L01EK01: Axitinib
HCPCS
No data
Clinical
Clinical Trials
170 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD002292123651055
NeoplasmsD009369C801182323
Non-small-cell lung carcinomaD002289310111
Kidney neoplasmsD007680EFO_0003865C6415218
Neuroendocrine tumorsD018358EFO_1001901D3A.8111
Pancreatic ductal carcinomaD02144111
Ovarian neoplasmsD010051EFO_0003893C5611
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545268
Liver neoplasmsD008113EFO_1001513C22.0268
Colorectal neoplasmsD0151792517
GlioblastomaD005909EFO_0000515235
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A112
Adenoid cystic carcinomaD00352822
Neoadjuvant therapyD02036022
Endometrial neoplasmsD016889EFO_000423022
PheochromocytomaD01067322
ParagangliomaD01023522
Show 25 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
GliosarcomaD01831611
Hepatocellular carcinomaD006528C22.011
Myeloid leukemia chronic-phaseD01546611
Castration-resistant prostatic neoplasmsD06412911
Stomach neoplasmsD013274EFO_0003897C1611
Hepatic insufficiencyD04855011
Neoplasm metastasisD009362EFO_000970811
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine cervical neoplasmsD00258311
Mantle-cell lymphomaD020522C83.111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAXITINIB
INNaxitinib
Description
Axitinib is an indazole substituted at position 3 by a 2-(pyridin-2-yl)vinyl group and at position 6 by a 2-(N-methylaminocarboxy)phenylsulfanyl group. Used for the treatment of advanced renal cell carcinoma after failure of a first line systemic treatment. It has a role as an antineoplastic agent, a tyrosine kinase inhibitor and a vascular endothelial growth factor receptor antagonist. It is a member of indazoles, a member of pyridines, an aryl sulfide and a member of benzamides.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1ccccc1Sc1ccc2c(/C=C/c3ccccn3)n[nH]c2c1
Identifiers
PDB4AG8
CAS-ID319460-85-0
RxCUI1242999
ChEMBL IDCHEMBL1289926
ChEBI ID66910
PubChem CID6450551
DrugBankDB06626
UNII IDC9LVQ0YUXG (ChemIDplus, GSRS)
Target
Agency Approved
KDR
KDR
Organism
Homo sapiens
Gene name
KDR
Gene synonyms
FLK1, VEGFR2
NCBI Gene ID
Protein name
vascular endothelial growth factor receptor 2
Protein synonyms
CD309, Fetal liver kinase 1, fetal liver kinase-1, FLK-1, KDR, Kinase insert domain receptor, kinase insert domain receptor (a type III receptor tyrosine kinase), Protein-tyrosine kinase receptor flk-1, soluble VEGFR2, tyrosine kinase growth factor receptor
Uniprot ID
Mouse ortholog
Kdr (16542)
vascular endothelial growth factor receptor 2 (Q8VCD0)
Alternate
PLK4
PLK4
Organism
Homo sapiens
Gene name
PLK4
Gene synonyms
SAK, STK18
NCBI Gene ID
Protein name
serine/threonine-protein kinase PLK4
Protein synonyms
PLK-4, Polo-like kinase 4, Serine/threonine-protein kinase 18, Serine/threonine-protein kinase Sak, Snk akin kinase
Uniprot ID
Mouse ortholog
Plk4 (20873)
serine/threonine-protein kinase PLK4 (Q9CVU6)
Variants
Clinical Variant
No data
Financial
Inlyta - Pfizer
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,703 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,984 adverse events reported
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