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Darbepoetin alpha
Darbepoetin alpha is a Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by Barts & The London NHS Trust. 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. Also known as: Aranesp.
Darbepoetin alpha is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production.
Darbepoetin alpha is a protein-based erythropoietin receptor agonist used to treat various conditions, including anemia of chronic kidney disease and anemia. It works by stimulating the erythropoietin receptor to promote the production of red blood cells.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Darbepoetin alpha |
|---|---|
| Also known as | Aranesp |
| Sponsor | Barts & The London NHS Trust |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Darbepoetin alpha is a recombinant human erythropoietin analog with a longer half-life than epoetin alfa due to additional carbohydrate chains. It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, promoting their proliferation, differentiation, and maturation into mature 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
- Injection site pain/reaction
- Pure red cell aplasia (rare)
Key clinical trials
- Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes (PHASE3)
- The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy (PHASE2)
- A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (PHASE3)
- Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) (PHASE2)
- Darbepoetin in Neonatal Encephalopathy Trial (PHASE2)
- Mild Encephalopathy in the Newborn Treated With Darbepoetin (PHASE2)
- Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
- Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease (PHASE4)
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:
- Darbepoetin alpha CI brief — competitive landscape report
- Darbepoetin alpha updates RSS · CI watch RSS
- Barts & The London NHS Trust portfolio CI
Frequently asked questions about Darbepoetin alpha
What is Darbepoetin alpha?
How does Darbepoetin alpha work?
What is Darbepoetin alpha used for?
Who makes Darbepoetin alpha?
Is Darbepoetin alpha also known as anything else?
What drug class is Darbepoetin alpha in?
What development phase is Darbepoetin alpha in?
What are the side effects of Darbepoetin alpha?
What does Darbepoetin alpha target?
Related
- Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Erythropoietin receptor (EPOR)
- Manufacturer: Barts & The London NHS Trust — 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
- Also known as: Aranesp
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing