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Aranesp® (darbepoetin alfa)
Aranesp® (darbepoetin alfa) is a Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by Amgen. It is currently in Phase 3 development for Anemia associated with chronic kidney disease, Anemia in patients with non-myeloid malignancies receiving chemotherapy, Anemia of chronic disease.
Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production.
Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production. Used for Anemia associated with chronic kidney disease, Anemia in patients with non-myeloid malignancies receiving chemotherapy, Anemia of chronic disease.
At a glance
| Generic name | Aranesp® (darbepoetin alfa) |
|---|---|
| Sponsor | Amgen |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Darbepoetin alfa is a recombinant human erythropoietin analog engineered with two additional N-linked carbohydrate chains, which extends its half-life compared to epoetin alfa. It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, activating JAK2 signaling and promoting proliferation, differentiation, and maturation of red blood cells. This mechanism increases hemoglobin levels and reduces the need for blood transfusions in patients with anemia.
Approved indications
- Anemia associated with chronic kidney disease
- Anemia in patients with non-myeloid malignancies receiving chemotherapy
- Anemia of chronic disease
Common side effects
- Hypertension
- Thrombovascular events (stroke, myocardial infarction, venous thromboembolism)
- Headache
- Fatigue
- Arthralgia
- Injection site pain
Key clinical trials
- Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
- Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis (PHASE1)
- A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD) (PHASE3)
- Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (PHASE3)
- A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (PHASE2)
- A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
- Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers (PHASE4)
- Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aranesp® (darbepoetin alfa) CI brief — competitive landscape report
- Aranesp® (darbepoetin alfa) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Aranesp® (darbepoetin alfa)
What is Aranesp® (darbepoetin alfa)?
How does Aranesp® (darbepoetin alfa) work?
What is Aranesp® (darbepoetin alfa) used for?
Who makes Aranesp® (darbepoetin alfa)?
What drug class is Aranesp® (darbepoetin alfa) in?
What development phase is Aranesp® (darbepoetin alfa) in?
What are the side effects of Aranesp® (darbepoetin alfa)?
What does Aranesp® (darbepoetin alfa) target?
Related
- Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Erythropoietin receptor (EPOR)
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Hematology/Oncology
- Indication: Drugs for Anemia associated with chronic kidney disease
- Indication: Drugs for Anemia in patients with non-myeloid malignancies receiving chemotherapy
- Indication: Drugs for Anemia of chronic disease
- Compare: Aranesp® (darbepoetin alfa) vs similar drugs
- Pricing: Aranesp® (darbepoetin alfa) cost, discount & access