Mobocertinib
Exkivity (mobocertinib) is a small molecule pharmaceutical. Mobocertinib was first approved as Exkivity on 2021-09-15. It is used to treat non-small-cell lung carcinoma in the USA. It is known to target epidermal 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
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| exkivity | New Drug Application | 2023-09-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MOBOCERTINIB SUCCINATE, EXKIVITY, TAKEDA PHARMS USA | |||
| 2028-09-15 | ODE-374 | ||
| 2026-09-15 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
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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 | — | — | 4 | 3 | 1 | — | 3 | 9 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 2 | 1 | — | 2 | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | 1 | 1 | — | — | — | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 1 | — | — | — | 1 |
| Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 1 | 1 | — | — | — | 1 |
| Bronchogenic carcinoma | D002283 | — | — | 1 | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | 1 | — | — | — | 1 |
| Neoplasms by site | D009371 | — | — | 1 | 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 | — | — | — | 6 | — | — | — | — | 6 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mobocertinib |
| INN | mobocertinib |
| Description | Mobocertinib, sold under the brand name Exkivity, is used for the treatment of non-small cell lung cancer.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors: epidermal growth factor receptor (EGFR) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CC(=O)Nc1cc(Nc2ncc(C(=O)OC(C)C)c(-c3cn(C)c4ccccc34)n2)c(OC)cc1N(C)CCN(C)C |
Identifiers
| PDB | — |
| CAS-ID | 1847461-43-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650319 |
| ChEBI ID | — |
| PubChem CID | 118607832 |
| DrugBank | DB16390 |
| UNII ID | 39HBQ4A67L (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Exkivity – Takeda
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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 499 documents
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Safety
Black-box Warning
Black-box warning for: Exkivity
Adverse Events
Top Adverse Reactions
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691 adverse events reported
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