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 |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
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 |
|---|---|---|---|---|
| NERLYNX | Puma Biotechnology | N-208051 RX | 2017-07-17 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nerlynx | New Drug Application | 2024-03-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NERATINIB MALEATE, NERLYNX, PUMA BIOTECH | |||
| 2024-06-28 | D-182 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Neratinib Maleate, Nerlynx, Puma Biotech | |||
| 8669273 | 2031-07-18 | U-3047 | |
| 7399865 | 2030-12-29 | DS, DP | |
| 8518446 | 2030-11-20 | DP | U-2043, U-3047, U-3097 |
| 8790708 | 2030-11-05 | DP | U-2043, U-3047, U-3097 |
| 9211291 | 2030-03-24 | U-2043, U-3097 | |
| 9265784 | 2029-08-04 | U-3047 | |
| 9139558 | 2028-10-15 | U-2043, U-3047, U-3097 | |
| 9630946 | 2028-10-15 | U-2043, U-3047, U-3097 | |
| 10035788 | 2028-10-15 | U-2043, U-3047, U-3097 | |
| 7982043 | 2025-10-08 | U-2043, U-3047, U-3097 | |
HCPCS
No data
Clinical
Clinical Trials
99 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 |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 15 | 35 | 4 | — | 7 | 52 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | — | 2 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 13 | 10 | — | — | — | 19 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 5 | — | — | — | 9 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 4 | — | — | 1 | 6 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 4 | — | — | 1 | 5 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 2 | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 1 | — | — | — | 2 |
| Diarrhea | D003967 | — | R19.7 | — | 1 | — | — | 1 | 2 |
Show 29 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | 1 | 11 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
Show 19 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine cervical neoplasms | D002583 | — | — | — | — | — | — | 1 | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 1 | 1 |
| Neoadjuvant therapy | D020360 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Neratinib |
| INN | neratinib |
| 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 class | tyrosine 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-ID | 698387-09-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL180022 |
| ChEBI ID | — |
| PubChem CID | 9915743 |
| DrugBank | DB11828 |
| UNII ID | JJH94R3PWB (ChemIDplus, GSRS) |
Target
Agency Approved
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
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
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
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
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£
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Nerlynx – Puma Biotechnology
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,210 adverse events reported
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