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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Exkivity
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mobocertinib succinate
Tradename
Company
Number
Date
Products
EXKIVITYTakedaN-215310 RX2021-09-15
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
exkivityNew Drug Application2021-09-22
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
2028-09-15ODE-374
2026-09-15NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Mobocertinib Succinate, Exkivity, Takeda Pharms Usa
97967122035-05-13DS, DP
102273422035-05-13DS, DPU-3220
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289321—16
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6————6
Lung neoplasmsD008175C34.901————1
Hepatic insufficiencyD0485501————1
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMOBOCERTINIB
INNmobocertinib
Description
Mobocertinib, sold under the brand name Exkivity, is used for the treatment of non-small cell lung cancer.
Classification
Small molecule
Drug classtyrosine 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-ID1847461-43-1
RxCUI—
ChEMBL IDCHEMBL4650319
ChEBI ID—
PubChem CID118607832
DrugBankDB16390
UNII ID39HBQ4A67L (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
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
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 258 documents
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Safety
Black-box Warning
Black-box warning for: Exkivity
Adverse Events
Top Adverse Reactions
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5 adverse events reported
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