Enbrel(etanercept)
Benepali, Enbrel, Erelzi, Eticovo, Nepexto (etanercept) is a protein pharmaceutical. Etanercept was first approved as Enbrel on . It is used to treat ankylosing spondylitis, juvenile arthritis, psoriatic arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat ankylosing spondylitis, arthritis, psoriasis, psoriatic arthritis, and rheumatoid arthritis amongst others. The pharmaceutical is active against tumor necrosis factor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Enbrel (discontinued: Enbrel, Erelzi, Eticovo)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enbrel | Biologic Licensing Application | 2024-11-04 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
etanercept, Enbrel, Immunex Corporation | |||
| 2106-05-27 | Orphan excl. | ||
etanercept, Enbrel Mini, Immunex Corporation | |||
| 2106-05-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1438 | Injection, etanercept, 25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
507 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | 6 | 10 | 27 | 43 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 3 | 9 | 21 | 33 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | 2 | 4 | 17 | 23 |
| Spondylitis | D013166 | — | M46.9 | — | — | 1 | 4 | 8 | 13 |
| Spondylarthritis | D025241 | — | — | — | — | 1 | 3 | 7 | 11 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 1 | 2 | 7 | 10 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | 1 | 7 | 8 |
| Axial spondyloarthritis | D000089183 | — | — | — | — | — | 2 | 1 | 3 |
| Rheumatic fever | D012213 | EFO_1001160 | I00-I02 | — | — | — | 1 | — | 1 |
| Non-radiographic axial spondyloarthritis | D000089202 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 3 | — | 1 | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Discoid lupus erythematosus | D008179 | — | — | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | — | — | — | 1 |
| Cutaneous lupus erythematosus | D008178 | EFO_0003834 | L93.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 2 | 2 |
| Papulosquamous skin diseases | D017444 | — | L40-L45 | — | — | — | — | 2 | 2 |
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Etanercept |
| INN | etanercept |
| Description | Etanercept, sold under the brand name Enbrel among others, is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.
|
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: tumor necrosis factor receptors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201572 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00005 |
| UNII ID | OP401G7OJC (ChemIDplus, GSRS) |
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
No data
Financial
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Benepali – Biogen
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Etanercept – Organon
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Enbrel – Pfizer
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Enbrel – Amgen
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Tabular view
Estimated US medical usage
Etanercept
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,252 documents
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Safety
Black-box Warning
Black-box warning for: Enbrel
Adverse Events
Top Adverse Reactions
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594,439 adverse events reported
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