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 testis-specific serine/threonine-protein kinase 1, receptor-type tyrosine-protein kinase FLT3, insulin-like growth factor 1 receptor, and insulin receptor.
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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Zykadia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ceritinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYKADIA | Novartis | N-211225 RX | 2019-03-18 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zykadia | New Drug Application | 2020-06-03 |
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
46 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | 2 | — | — | 1 | 5 | |
| Neuroblastoma | D009447 | EFO_0000621 | 1 | 2 | — | — | — | 3 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 2 | |
| Large-cell lymphoma anaplastic | D017728 | C84.6 | 1 | 2 | — | — | — | 2 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Cholangiocarcinoma | D018281 | C22.1 | — | 2 | — | — | — | 2 | |
| Glioblastoma | D005909 | EFO_0000515 | 1 | 1 | — | — | — | 2 | |
| Squamous cell carcinoma | D002294 | — | 1 | — | — | — | 1 | ||
| Invasive hydatidiform mole | D002820 | D39.2 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Gene rearrangement | D015321 | 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 | 4MKC |
| CAS-ID | 1032900-25-6 |
| RxCUI | 1535457 |
| 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)
Alternate
TSSK1B
TSSK1B
FLT3
FLT3
IGF1R
IGF1R
INSR
INSR
Organism
Homo sapiens
Gene name
TSSK1B
Gene synonyms
SPOGA1, SPOGA4, STK22A, STK22D, TSSK1
NCBI Gene ID
Protein name
testis-specific serine/threonine-protein kinase 1
Protein synonyms
serine/threonine kinase 22D (spermiogenesis associated), serine/threonine kinase FKSG81, Serine/threonine-protein kinase 22A, spermiogenesis associated 4, testis tissue sperm-binding protein Li 55e, testis-specific kinase 1, testis-specific serine kinase 1, TSK-1, TSSK-1
Uniprot ID
Mouse ortholog
Tssk1 (22114)
testis-specific serine/threonine-protein kinase 1 (Q80YU1)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,275 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4 adverse events reported
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