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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aranesp | Biologic Licensing Application | 2019-01-30 |
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
176 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 | 4 | 30 | 48 | 9 | 7 | 95 |
| Chronic renal insufficiency | D051436 | N18 | 2 | 4 | 24 | 6 | 4 | 40 | |
| Neoplasms | D009369 | C80 | 1 | 9 | 8 | 2 | 1 | 20 | |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 9 | 5 | — | 14 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | 5 | 2 | 2 | 10 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | — | — | 1 | — | 1 | |
| Drug therapy | D004358 | — | — | — | 1 | — | 1 | ||
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 2 | 6 | 3 | — | — | 8 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 4 | 1 | — | 1 | 6 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 2 | — | 1 | 6 |
| Lymphoma | D008223 | C85.9 | — | 3 | 2 | — | — | 5 | |
| Leukemia | D007938 | C95 | — | 2 | 2 | — | — | 4 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | — | 1 | 3 |
| Lung neoplasms | D008175 | C34.90 | — | 2 | 1 | — | — | 3 | |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | 2 | — | — | 3 |
| Plasma cell neoplasms | D054219 | — | 1 | 2 | — | — | 3 | ||
| Large b-cell lymphoma diffuse | D016403 | C83.3 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 2 | — | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | — | 2 |
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | 1 | 2 | — | — | — | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | — | — | — | 1 | |
| Spinal cord ischemia | D020760 | EFO_1001426 | — | 1 | — | — | — | 1 | |
| Neuroprotection | D000066829 | — | 1 | — | — | — | 1 | ||
| Dysgerminoma | D004407 | — | 1 | — | — | — | 1 | ||
| Female genital neoplasms | D005833 | — | 1 | — | — | — | 1 | ||
| Neutropenia | D009503 | D70 | — | 1 | — | — | — | 1 | |
| Uterine cervical neoplasms | D002583 | — | 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 | — | 3 | — | — | — | — | 3 | ||
| Reticulocyte count | D017701 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Continuous ambulatory peritoneal dialysis | D010531 | — | — | — | — | 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 | 209810-58-2 |
| RxCUI | 283838 |
| ChEMBL ID | CHEMBL1201566 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00012 |
| UNII ID | 15UQ94PT4P (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Aranesp - Amgen
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Additional graphs summarizing 2,570 documents
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Safety
Black-box Warning
Black-box warning for: Aranesp
Adverse Events
Top Adverse Reactions
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11,845 adverse events reported
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