Zykadia(ceritinib)
Zykadia (ceritinib) is a small molecule pharmaceutical. Ceritinib was first approved as Zykadia on 2014-04-29. 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 insulin receptor, insulin-like growth factor 1 receptor, receptor-type tyrosine-protein kinase FLT3, and testis-specific serine/threonine-protein kinase 1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Zykadia (discontinued: Zykadia)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zykadia | New Drug Application | 2025-12-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CERITINIB, ZYKADIA, NOVARTIS | |||
| 2024-05-26 | ODE*, ODE-145 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ceritinib, Zykadia, Novartis | |||
| 8703787 | 2032-02-02 | U-1179 | |
| 9309229 | 2032-01-18 | DS, DP | |
| 8039479 | 2030-06-29 | DS, DP | |
| 7964592 | 2028-04-29 | DS, DP | |
| 8377921 | 2027-11-20 | U-1179 | |
| 8399450 | 2027-11-20 | DS, DP | |
| 7893074 | 2026-04-25 | DS, DP | |
| 8188276 | 2023-01-31 | DS, DP | |
| 8835430 | 2023-01-31 | DS, DP | |
| 9018204 | 2023-01-31 | DS, DP | |
| 9416112 | 2023-01-31 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 6 | 5 | 2 | — | 3 | 15 |
| Lung neoplasms | D008175 | — | C34.90 | 5 | 6 | 2 | — | 2 | 14 |
| Adenocarcinoma of lung | D000077192 | — | — | — | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | — | 3 | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | — | — | — | 3 |
| Melanoma | D008545 | — | — | 1 | 1 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | 1 | — | — | 1 | 2 |
| Plasma cell granuloma | D006104 | — | — | — | 1 | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | — | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | — | 1 |
| Chromosome aberrations | D002869 | Orphanet_68335 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ceritinib |
| INN | ceritinib |
| Description | Ceritinib is a member of the class of aminopyrimidines that is 2,6-diamino-5-chloropyrimidine in which the amino groups at positions 2 and 6 are respectively carrying 2-methoxy-4-(piperidin-4-yl)-5-methylphenyl and 2-(isopropylsulfonyl)phenyl substituents. Used for the treatment of ALK-positive metastatic non-small cell lung cancer. It has a role as an antineoplastic agent and an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor. It is an aminopyrimidine, an aromatic ether, an organochlorine compound, a secondary amino compound, a member of piperidines and a sulfone. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(Nc2ncc(Cl)c(Nc3ccccc3S(=O)(=O)C(C)C)n2)c(OC(C)C)cc1C1CCNCC1 |
Identifiers
| PDB | — |
| CAS-ID | 1032900-25-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2403108 |
| ChEBI ID | 78432 |
| PubChem CID | 57379345 |
| DrugBank | DB09063 |
| UNII ID | K418KG2GET (ChemIDplus, GSRS) |
Target
Agency Approved
ALK
ALK
Organism
Homo sapiens
Gene name
ALK
Gene synonyms
NCBI Gene ID
Protein name
ALK tyrosine kinase receptor
Protein synonyms
Anaplastic lymphoma kinase, anaplastic lymphoma receptor tyrosine kinase, CD246, CD246 antigen, mutant anaplastic lymphoma kinase
Uniprot ID
Mouse ortholog
Alk (11682)
ALK tyrosine kinase receptor (P97793)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,352 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,864 adverse events reported
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