Back to discover
Drug

Darbepoetin alfa

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Aranesp, Darbepoetin, Darbepoetina alfa, DARBEPOETIN ALFA,RECOMBINANT.

RxNorm283838UNII15UQ94PT4P
4
Research papers
8
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Clinical trial2026-07-01Results posted · ClinicalTrials.gov

Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants

Clinical trial2026-05-26Results expected Q1 2027 · ClinicalTrials.gov

A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Clinical trial2026-05-22Results expected Q2 2027 · ClinicalTrials.gov

Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis -A Pilot Randomised Controlled Trial.

Clinical trial2026-05-22Results expected Q4 2026 · ClinicalTrials.gov

A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Clinical trial2026-04-06Results posted · ClinicalTrials.gov

A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Clinical trial2026-04-06Results posted · ClinicalTrials.gov

Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study.

Research2021-08-01Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Phase 3 Randomized Study Comparing Vadadustat with Darbepoetin Alfa for Anemia in Japanese Patients with Nondialysis-Dependent CKD.

Research2021-04-21Journal of the American Society of Nephrology : JASN

Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis.

Research2013-01-01The New England journal of medicine

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia.

Research2010-09-01American journal of hematology

Approval: Aranesp (EMA)

Regulatory2001-06-08EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Darbepoetin alfa
Aliases & brands
AranespDarbepoetinDarbepoetina alfaDARBEPOETIN ALFA,RECOMBINANT
RxNorm CUI
283838
UNII
15UQ94PT4P
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2001-06-08
Latest approval
2001-06-08
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2001-06-08Approval
Approval: Aranesp (EMA)
Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with… Show full indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

149 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
149
registered trials across all phases
LATEST COMPLETION 2025
8
Active studies
6
Recruiting
95
Late-stage (III+)
117
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 149
Phase 16Phase 1 / 24Phase 244Phase 2 / 33Phase 371Phase 413Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study

Active, not recruitingPH IVGangnam Severance Hospitaln=402026

Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin as Erythropoietic Agents for Treatment of Anemia in Pediatric Chronic Kidney Disease Patients

CompletedPH IVRufaida Mazahirn=502019

A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

CompletedPH IVKey trialHoffmann-La Rochen=2,8252017

A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients

CompletedPH IVAbbVie (prior sponsor, Abbott)n=652016

Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.

CompletedPH IVHamad Medical Corporationn=3272013

Recent completions

Trials that read out recently, adding to the completed evidence base.

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

CompletedPH IIINICHD Neonatal Research Networkn=6502025

Mild Encephalopathy in the Newborn Treated With Darbepoetin (MEND)

CompletedPH IIUniversity of New Mexicon=282022

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

CompletedPH IIIAkebia Therapeuticsn=3192022

A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis

CompletedPH IIIZydus Lifesciences Limitedn=5882021

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

CompletedPH IIIKey trialGlaxoSmithKlinen=3,8722021

A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group, Phase III Study to Compare the Efficacy and Safety of JTZ-951 With Darbepoetin Alfa in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis.

CompletedPH IIIJW Pharmaceuticaln=1722021

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102021
Most influential

Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis.

The New England journal of medicine · 2013 · 78 cites

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia.

American journal of hematology · 2010 · 64 cites

Phase 3 Randomized Study Comparing Vadadustat with Darbepoetin Alfa for Anemia in Japanese Patients with Nondialysis-Dependent CKD.

Journal of the American Society of Nephrology : JASN · 2021 · 61 cites

Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021 · 50 cites
Recent papers

Phase 3 Randomized Study Comparing Vadadustat with Darbepoetin Alfa for Anemia in Japanese Patients with Nondialysis-Dependent CKD.

Journal of the American Society of Nephrology : JASN · 2021 · 61 cites

Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021 · 50 cites

Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis.

The New England journal of medicine · 2013 · 78 cites

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia.

American journal of hematology · 2010 · 64 cites
Major research themes3
Anemia1Erythropoietin1Hematinics1
Journals, researchers & institutions
Top journals
  • American journal of hematology1
  • Journal of the American Society of Nephrology : JASN1
  • Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association1
  • The New England journal of medicine1
Leading researchers
  • Kaneko G2
  • Kawaguchi Y2
  • Kokado Y2
  • Komatsu Y2
  • Kondo K2
  • Nangaku M2
  • Ueta K2
  • Auerbach M1
Leading institutions
free-text, unnormalised
  • Graduate School of Medicine2
  • King's College Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.