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Drug ReportsCeritinib
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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Novartis Pharmaceuticals
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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
Zykadia (discontinued: 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
ZYKADIANovartisN-211225 RX2019-03-18
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
zykadiaNew Drug Application2024-07-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
CERITINIB, ZYKADIA, NOVARTIS
2024-05-26ODE*, ODE-145
Patent Expiration
Patent
Expires
Flag
FDA Information
Ceritinib, Zykadia, Novartis
87037872032-02-02U-1179
93092292032-01-18DS, DP
80394792030-06-29DS, DP
79645922028-04-29DS, DP
83779212027-11-20U-1179
83994502027-11-20DS, DP
78930742026-04-25DS, DP
81882762023-01-31DS, DP
88354302023-01-31DS, DP
90182042023-01-31DS, DP
94161122023-01-31DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01ED: Anaplastic lymphoma kinase (alk) inhibitors
— L01ED02: Ceritinib
HCPCS
No data
Clinical
Clinical Trials
56 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——81021727
Lung neoplasmsD008175HP_0100526C34.9061121322
NeoplasmsD009369—C8066—1113
Neoplasm metastasisD009362EFO_0009708—21—1—4
Meningeal carcinomatosisD055756EFO_1001012————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.932——15
AdenocarcinomaD000230———3———3
MelanomaD008545——12———3
NeuroblastomaD009447EFO_0000621—12———3
Adenocarcinoma of lungD000077192———2———2
Brain neoplasmsD001932EFO_0003833C7111———2
Large-cell lymphoma anaplasticD017728—C84.612———2
Pancreatic neoplasmsD010190EFO_0003860C2511———2
CholangiocarcinomaD018281—C22.1—2———2
GlioblastomaD005909EFO_0000515—11———2
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gene rearrangementD015321——1————1
Liver diseasesD008107HP_0002910K70-K771————1
Congenital abnormalitiesD000013EFO_0003915Q89.91————1
Chromosome aberrationsD002869Orphanet_68335—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95————11
Myeloid leukemia acuteD015470—C92.0————11
RecurrenceD012008——————11
Precursor cell lymphoblastic leukemia-lymphomaD054198——————11
Myeloid leukemiaD007951—C92————11
Acute diseaseD000208——————11
Lymphoid leukemiaD007945—C91————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCeritinib
INNceritinib
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 classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
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-ID1032900-25-6
RxCUI—
ChEMBL IDCHEMBL2403108
ChEBI ID78432
PubChem CID57379345
DrugBankDB09063
UNII IDK418KG2GET (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
INSR
INSR
IGF1R
IGF1R
FLT3
FLT3
TSSK1B
TSSK1B
Organism
Homo sapiens
Gene name
INSR
Gene synonyms
NCBI Gene ID
Protein name
insulin receptor
Protein synonyms
CD220, IR
Uniprot ID
Mouse ortholog
Insr (16337)
insulin receptor (P15208)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,211 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,804 adverse events reported
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