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Drug ReportsAxitinib
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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Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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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 Application2025-02-19
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
226 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 carcinomaD002292EFO_0000376—5166—1441
CarcinomaD002277—C80.03142—827
NeoplasmsD009369—C801052—218
Kidney neoplasmsD007680EFO_0003865C64153—312
Non-small-cell lung carcinomaD002289——471——9
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
MelanomaD008545——15———6
Colorectal neoplasmsD015179——34———6
Hepatocellular carcinomaD006528—C22.033———6
Lung neoplasmsD008175—C34.9025———5
Liver neoplasmsD008113EFO_1001513C22.023———5
GlioblastomaD005909EFO_0000515—12———3
Thyroid neoplasmsD013964EFO_0003841——3———3
Thyroid diseasesD013959—E00-E07—3———3
Endometrial neoplasmsD016889EFO_0004230—11———2
SarcomaD012509———2———2
Show 25 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Stomach neoplasmsD013274EFO_0003897C162————2
Castration-resistant prostatic neoplasmsD064129——1————1
MalnutritionD044342EFO_0008572E40-E461————1
Liver failureD017093—K72.91————1
Hepatic insufficiencyD048550——1————1
Esophageal neoplasmsD004938—C151————1
Transitional cell carcinomaD002295——1————1
Uterine cervical neoplasmsD002583——1————1
Small cell lung carcinomaD055752——1————1
Show 2 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9————11
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A————11
Mantle-cell lymphomaD020522—C83.1————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)Loading
Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1ccccc1Sc1ccc2c(/C=C/c3ccccn3)n[nH]c2c1
Identifiers
PDB—
CAS-ID319460-85-0
RxCUI—
ChEMBL IDCHEMBL1289926
ChEBI ID66910
PubChem CID6450551
DrugBankDB06626
UNII IDC9LVQ0YUXG (ChemIDplus, GSRS)
Target
Agency Approved
No data
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
No data
Financial
Revenue by drug
$
€
£
₣
Inlyta – Pfizer
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,190 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18,666 adverse events reported
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