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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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 |
|---|---|---|---|---|
| XALKORI | CV Sciences | N-202570 RX | 2011-08-26 | 2 products, RLD, RS |
| XALKORI | CV Sciences | N-217581 RX | 2023-09-07 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xalkori | New Drug Application | 2025-07-22 |
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 | |||
| 2029-07-14 | ODE-407 | ||
| 2028-01-14 | ODE-328 | ||
| 2025-07-14 | I-897 | ||
| 2024-01-14 | I-852 | ||
| 2023-03-11 | ODE-111 | ||
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 carcinoma | D002289 | — | — | 18 | 35 | 21 | 2 | 21 | 89 |
| Lymphoma | D008223 | — | C85.9 | 4 | 9 | — | 1 | 1 | 13 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 3 | 5 | — | 3 | — | 10 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 3 | — | 1 | — | 5 |
| Plasma cell granuloma | D006104 | — | — | — | 2 | 1 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 17 | 26 | 10 | — | 12 | 59 |
| Neoplasms | D009369 | — | C80 | 11 | 13 | 2 | — | 5 | 27 |
| Carcinoma | D002277 | — | C80.0 | 2 | 3 | 2 | — | — | 7 |
| Melanoma | D008545 | — | — | 1 | 5 | 1 | — | 1 | 6 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | 3 | 1 | — | — | 3 |
| Uveal melanoma | D000098943 | — | — | 1 | 3 | 1 | — | — | 3 |
| Adenocarcinoma of lung | D000077192 | — | — | — | 2 | 1 | — | — | 3 |
| Gene rearrangement | D015321 | — | — | — | 1 | 1 | — | 1 | 3 |
| Multiple endocrine neoplasia type 2a | D018813 | — | E31.22 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 4 | — | — | 1 | 7 |
| Multiple myeloma | D009101 | — | C90.0 | — | 6 | — | — | — | 6 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 5 | — | — | — | 6 |
| Colorectal neoplasms | D015179 | — | — | 2 | 4 | — | — | 1 | 6 |
| Recurrence | D012008 | — | — | 3 | 2 | — | — | 1 | 5 |
| Adenocarcinoma | D000230 | — | — | 1 | 3 | — | — | — | 4 |
| Hematologic neoplasms | D019337 | — | — | — | 4 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 3 | — | — | — | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 3 | — | — | — | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 3 | — | — | — | 3 |
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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 | — | — | — | 14 | — | — | — | — | 14 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | 1 | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Large cell carcinoma | D018287 | — | — | 1 | — | — | — | — | 1 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | — | — | — | — | 1 | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
| Molecular targeted therapy | D058990 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Crizotinib |
| INN | crizotinib |
| 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 class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](Oc1cc(-c2cnn(C3CCNCC3)c2)cnc1N)c1c(Cl)ccc(F)c1Cl |
Identifiers
| PDB | — |
| CAS-ID | 877399-52-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL601719 |
| ChEBI ID | 64310 |
| PubChem CID | 11626560 |
| DrugBank | DB08865 |
| UNII ID | 53AH36668S (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
MET
MET
Organism
Homo sapiens
Gene name
MET
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Met (17295)
hepatocyte growth factor receptor (P16056)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xalkori – Pfizer
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,931 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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