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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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Alecensa
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alecensa | New Drug Application | 2022-06-16 |
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 | |||
| 2024-11-06 | ODE-159 | ||
HCPCS
No data
Clinical
Clinical Trials
82 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 | — | — | 8 | 21 | 6 | 1 | 7 | 36 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 3 | — | 1 | 1 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | — | 1 |
| Drug monitoring | D016903 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 11 | 3 | — | 1 | 15 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 2 | 1 | — | — | 2 |
| Neoplasms by site | D009371 | — | — | — | 2 | 1 | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | 1 | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | 1 | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | 1 | 1 | — | — | 1 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | 1 | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 2 | — | — | 1 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 2 | — | — | — | 2 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 2 | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 2 | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 1 | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 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 | — | — | — | 5 | — | — | — | — | 5 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease resistance | D060467 | — | — | — | — | — | — | 1 | 1 |
| Mutation | D009154 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alectinib |
| INN | alectinib |
| 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 class | tyrosine 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-ID | 1256580-46-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1738797 |
| ChEBI ID | — |
| PubChem CID | 49806720 |
| DrugBank | DB11363 |
| UNII ID | LIJ4CT1Z3Y (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
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 (Q62125)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Alecensa – Roche
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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 4,500 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,660 adverse events reported
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