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Alecensa(alectinib)
Alecensa (alectinib) is a small molecule pharmaceutical. Alectinib was first approved as Alecensa on 2015-12-11. 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
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Alecensa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alectinib hydrochloride
Tradename
Company
Number
Date
Products
ALECENSARocheN-208434 RX2015-12-11
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
alecensaNew Drug Application2020-06-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
ALECTINIB HYDROCHLORIDE, ALECENSA, HOFFMANN-LA ROCHE
2024-11-06ODE-159
Patent Expiration
Patent
Expires
Flag
FDA Information
Alectinib Hydrochloride, Alecensa, Hoffmann-La Roche
103502142035-04-24DP
114330762035-04-24DP
93655142032-03-04DP
91269312031-05-29DP
94409222030-06-09DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01ED: Anaplastic lymphoma kinase (alk) inhibitors
— L01ED03: Alectinib
HCPCS
No data
Clinical
Clinical Trials
57 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 carcinomaD00228971651729
Lung neoplasmsD008175C34.90—2—114
Drug monitoringD016903———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80—102—112
Hematologic neoplasmsD019337—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—2———2
Gastrointestinal neoplasmsD005770C26.9—2———2
Salivary gland neoplasmsD012468EFO_0003826D11—2———2
Colorectal neoplasmsD015179—2———2
Ovarian neoplasmsD010051EFO_0003893C56—2———2
GlioblastomaD005909EFO_000051511———1
Urinary bladder neoplasmsD001749C67—1———1
Biliary tract neoplasmsD001661C24.9—1———1
Brain neoplasmsD001932EFO_0003833C71—1———1
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
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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—4————4
Hepatic insufficiencyD0485501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Disease resistanceD060467————11
MutationD009154————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameALECTINIB
INNalectinib
Description
Alectinib is an organic heterotetracyclic compound that is 6,6-dimethyl-5,6-dihydro-11H-benzo[b]carbazol-11-one carrying additional cyano, 4-(morpholin-4-yl)piperidin-1-yl and ethyl substituents at positions 3, 8 and 9 respectively. Used (as the hydrochloride salt) for the treatment of patients with anaplastic lymphoma kinase-positive, metastatic non-small cell lung cancer. It has a role as an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor and an antineoplastic agent. It is an organic heterotetracyclic compound, a member of morpholines, a member of piperidines, a nitrile and an aromatic ketone. It is a conjugate base of an alectinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCc1cc2c(cc1N1CCC(N3CCOCC3)CC1)C(C)(C)c1[nH]c3cc(C#N)ccc3c1C2=O
Identifiers
PDB—
CAS-ID1256580-46-7
RxCUI1727455
ChEMBL IDCHEMBL1738797
ChEBI ID—
PubChem CID49806720
DrugBankDB11363
UNII IDLIJ4CT1Z3Y (ChemIDplus, GSRS)
Target
Agency Approved
ALK
ALK
Organism
Homo sapiens
Gene name
ALK
Gene synonyms
NCBI Gene ID
238
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
Q9Y4K6
Mouse ortholog
Alk (11682)
ALK tyrosine kinase receptor (P97793)
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
Clinical Variant
No data
Financial
Alecensa - Roche
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,532 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,006 adverse events reported
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