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Nerlynx(neratinib)
Nerlynx (neratinib) is a small molecule pharmaceutical. Neratinib was first approved as Nerlynx on 2017-07-17. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2. In addition, it is known to target epidermal growth factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Nerlynx
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Neratinib maleate
Tradename
Company
Number
Date
Products
NERLYNXPuma BiotechnologyN-208051 RX2017-07-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nerlynxNew Drug Application2021-02-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
Expiration
Code
NERATINIB MALEATE, NERLYNX, PUMA BIOTECH
2024-06-28D-182
2023-02-25I-823
Patent Expiration
Patent
Expires
Flag
FDA Information
Neratinib Maleate, Nerlynx, Puma Biotech
86692732031-07-18U-3047
73998652030-12-29DS, DP
85184462030-11-20DPU-2043, U-3047, U-3097
87907082030-11-05DPU-2043, U-3047, U-3097
92112912030-03-24U-2043, U-3097
92657842029-08-04U-3047
91395582028-10-15U-2043, U-3047, U-3097
96309462028-10-15U-2043, U-3047, U-3097
100357882028-10-15U-2043, U-3047, U-3097
79820432025-10-08U-2043, U-3047, U-3097
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EH: Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors
— L01EH02: Neratinib
HCPCS
No data
Clinical
Clinical Trials
74 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
Breast neoplasmsD001943EFO_0003869C5013302—238
Biliary tract neoplasmsD001661C24.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80116———13
Triple negative breast neoplasmsD064726—3———3
Prostatic neoplasmsD011471C6111———2
Castration-resistant prostatic neoplasmsD06412911———2
Colorectal neoplasmsD01517912———2
Neurofibromatosis 2D016518Q85.02—1———1
Acoustic neuromaD009464HP_0009588—1———1
MeningiomaD008579EFO_0003098D32.9—1———1
EpendymomaD004806—1———1
HemangiosarcomaD006394—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—10———111
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Multiple myelomaD009101C90.01————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder neoplasmsD001749C67————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNERATINIB
INNneratinib
Description
Neratinib is a quinoline compound having a cyano group at the 3-position, a 3-chloro-4-(2-pyridylmethoxy)anilino group at the 4-position, a 4-dimethylamino-trans-but-2-enoylamido group at the 6-position, and an ethoxy group at the 7-position. It has a role as a tyrosine kinase inhibitor and an antineoplastic agent. It is a member of quinolines and a nitrile.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOc1cc2ncc(C#N)c(Nc3ccc(OCc4ccccn4)c(Cl)c3)c2cc1NC(=O)/C=C/CN(C)C
Identifiers
PDB—
CAS-ID698387-09-6
RxCUI1940643
ChEMBL IDCHEMBL180022
ChEBI ID—
PubChem CID9915743
DrugBankDB11828
UNII IDJJH94R3PWB (ChemIDplus, GSRS)
Target
Agency Approved
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
2064
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
P04626
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
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
Nerlynx - Puma Biotechnology
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,598 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,996 adverse events reported
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