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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 carcinomaD00229212365—1055
NeoplasmsD009369C801182—323
Non-small-cell lung carcinomaD0022893101——11
Kidney neoplasmsD007680EFO_0003865C64152—18
Neuroendocrine tumorsD018358EFO_1001901D3A.8—11——1
Pancreatic ductal carcinomaD021441——1——1
Ovarian neoplasmsD010051EFO_0003893C56——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854526———8
Liver neoplasmsD008113EFO_1001513C22.026———8
Colorectal neoplasmsD01517925——17
GlioblastomaD005909EFO_000051523———5
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A—1——12
Adenoid cystic carcinomaD003528—2———2
Neoadjuvant therapyD020360—2———2
Endometrial neoplasmsD016889EFO_0004230—2———2
PheochromocytomaD010673—2———2
ParagangliomaD010235—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
GliosarcomaD0183161————1
Hepatocellular carcinomaD006528C22.01————1
Myeloid leukemia chronic-phaseD0154661————1
Castration-resistant prostatic neoplasmsD0641291————1
Stomach neoplasmsD013274EFO_0003897C161————1
Hepatic insufficiencyD0485501————1
Neoplasm metastasisD009362EFO_00097081————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine cervical neoplasmsD002583————11
Mantle-cell lymphomaD020522C83.1————11
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
3791
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
Q14178
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
10733
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
O00444
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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