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Drug ReportsCrizotinib
Xalkori(crizotinib)
Xalkori (crizotinib) is a small molecule pharmaceutical. Crizotinib was first approved as Xalkori on 2011-08-26. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against ALK tyrosine kinase receptor. In addition, it is known to target hepatocyte growth factor receptor.
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Drugs Approved for Childhood Cancers
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Events Timeline
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1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Xalkori
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Crizotinib
Tradename
Company
Number
Date
Products
XALKORICV SciencesN-202570 RX2011-08-26
2 products, RLD, RS
XALKORICV SciencesN-217581 RX2023-09-07
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xalkoriNew Drug Application2025-07-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
CRIZOTINIB, XALKORI, PF PRISM CV
2029-07-14ODE-407
2028-01-14ODE-328
2025-07-14I-897
2024-01-14I-852
2023-03-11ODE-111
Patent Expiration
Patent
Expires
Flag
FDA Information
Crizotinib, Xalkori, Pf Prism Cv
82170572029-11-06DS, DP
78586432029-10-08DS, DP
78251372027-05-12U-3057, U-3058, U-3403
72300982025-08-26DP
87856322025-03-01DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01ED: Anaplastic lymphoma kinase (alk) inhibitors
— L01ED01: Crizotinib
HCPCS
No data
Clinical
Clinical Trials
169 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——71142829
Large-cell lymphoma anaplasticD017728—C84.622—1—4
Plasma cell granulomaD006104———1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175—C34.907101—217
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8076——314
LymphomaD008223—C85.932———3
Non-hodgkin lymphomaD008228—C85.912———2
Renal cell carcinomaD002292EFO_0000376—11———2
AdenocarcinomaD000230———2———2
Multiple myelomaD009101—C90.0—1———1
Squamous cell carcinomaD002294———1———1
Squamous cell neoplasmsD018307———1———1
Gene rearrangementD015321———1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Show 17 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———14————14
GlioblastomaD005909EFO_0000515—2————2
CarcinomaD002277—C80.01————1
Hepatocellular carcinomaD006528—C22.01————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Colorectal neoplasmsD015179——1————1
Prostatic neoplasmsD011471—C611————1
Castration-resistant prostatic neoplasmsD064129——1————1
Neoplasm metastasisD009362EFO_0009708—1————1
Renal insufficiencyD051437—N191————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCrizotinib
INNcrizotinib
Description
Crizotinib is a 3-[1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)pyrazol-4-yl]pyridin-2-amine that has R configuration at the chiral centre. The active enantiomer, it acts as a kinase inhibitor and is used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) It has a role as an antineoplastic agent, a biomarker and an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor. It is an enantiomer of an ent-crizotinib.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@H](Oc1cc(-c2cnn(C3CCNCC3)c2)cnc1N)c1c(Cl)ccc(F)c1Cl
Identifiers
PDB—
CAS-ID877399-52-5
RxCUI—
ChEMBL IDCHEMBL601719
ChEBI ID64310
PubChem CID11626560
DrugBankDB08865
UNII ID53AH36668S (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
MET
MET
Organism
Homo sapiens
Gene name
MET
Gene synonyms
NCBI Gene ID
4233
Protein name
hepatocyte growth factor receptor
Protein synonyms
HGF receptor, HGF/SF receptor, Proto-oncogene c-Met, Scatter factor receptor, SF receptor, Tyrosine-protein kinase Met
Uniprot ID
Q9UPL8
Mouse ortholog
Met (17295)
hepatocyte growth factor receptor (P16056)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xalkori – 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 16,781 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,212 adverse events reported
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