Aranesp(darbepoetin alfa)
Aranesp (darbepoetin alfa) is a protein pharmaceutical. Darbepoetin alfa was first approved as Aranesp on 2001-06-08. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, chronic kidney failure, and neoplasms.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Aranesp (discontinued: Aranesp)
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 |
|---|---|---|
| aranesp | Biologic Licensing Application | 2024-12-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | EFO_0004272 | D000740 | D64.9 |
Agency Specific
FDA
EMA
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Patent Expiration
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Clinical
Clinical Trials
241 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | 3 | 18 | 21 | 6 | 6 | 51 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | 13 | 6 | 4 | 24 |
| Neoplasms | D009369 | — | C80 | 1 | 11 | 11 | 2 | 1 | 24 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | 12 | 3 | 4 | 20 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 2 | 3 | — | 5 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 3 | — | 3 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | 1 | 1 | 2 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | — | 1 | — | 1 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 2 | — | 1 | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 2 | 3 | — | — | 5 |
| Preleukemia | D011289 | — | — | 1 | 2 | 3 | — | — | 5 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | 3 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | — | 1 | 5 |
| Syndrome | D013577 | — | — | 1 | 2 | 2 | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | 1 | — | 1 | 3 |
| Hematologic neoplasms | D019337 | — | — | 1 | 2 | 1 | — | 1 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | 1 | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | 1 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | — | 1 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 1 | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | — | — | — | 1 | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 1 | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Darbepoetin alfa |
| INN | darbepoetin alfa |
| Description | Erythropoietin precursor (Epoetin) |
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201566 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00012 |
| UNII ID | 15UQ94PT4P (ChemIDplus, GSRS) |
Target
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Aranesp – Amgen
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Estimated US medical usage
Darbepoetin alfa
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Trends
PubMed Central
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Additional graphs summarizing 5,233 documents
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Safety
Black-box Warning
Black-box warning for: Aranesp
Adverse Events
Top Adverse Reactions
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43,813 adverse events reported
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