Darbepoetin alfa
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | ARANESP | — | 2002-07-19 – 2019-01-30 | fda.gov ↗ |
| Approved | US (FDA) | ARANESP | — | 2001-09-17 | fda.gov ↗ |
| Approved | EU (EMA) | Aranesp | — | 2001-06-08 | europa.eu ↗ |
Trials 124 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT05636891 | Sep 2021 → Nov 2022 | chronic kidney disease | Nanogen Pharmaceutical Biotechnology Joint Stock Company | Completed | No outcome recorded |
| Phase 1 | NCT03693950 | Mar → Jul 2017 | — | Biocad | Completed | No outcome recorded |
| Phase 1 | NCT01428154 | Apr → Nov 2016 | anemia, chronic kidney disease | Amgen | Withdrawn | No outcome recorded |
| Phase 1 | NCT02241200 | Aug → Nov 2014 | anemia | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02506881 | Mar 2013 → Jul 2014 | — | Biocad | Completed | No outcome recorded |
| Phase 1 | NCT01685671 | Oct → Dec 2012 | anemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01684605 | Oct → Nov 2012 | anemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT00117247 | Jun 2002 → Jul 2004 | anemia, congestive heart failure | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT00230321 | Feb 2002 → Nov 2007 | myelodysplastic syndrome | Peter L Greenberg | Completed | No outcome recorded |
| Phase 1/2 | NCT00540384 | Jul 1999 → Mar 2002 | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 239 trials | ||||||
| Phase 2 | NCT07096297 | Dec 2025 → Aug 2030 expected | myelodysplastic syndrome | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05340465 | Nov 2022 → Jan 2027 expected | disorder of iron metabolism and transport, iron deficiency anemia | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT03457701 | Jul 2019 → Jul 2022 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03071861 | Dec 2017 → Dec 2019 | perinatal asphyxia | University of New Mexico | Completed | No outcome recorded |
| Phase 2 | NCT03171818 | Jul 2017 → Dec 2024 | stroke disorder | UMC Utrecht | Unknown | No outcome recorded |
| Phase 2 | NCT01977573 | Oct 2013 → May 2015 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02890602 | Sep 2012 → Nov 2017 | diffuse large B-cell lymphoma | Kosin University Gospel Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01497145 | Dec 2011 → Feb 2014 | myelodysplastic syndrome | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01222195 | Feb 2008 → Jul 2010 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00647998 | Jan 2008 → Jul 2010 | spinal cord ischemia | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00416624 | May 2007 → Jun 2009 | anemia, leukemia, lymphoproliferative syndrome, plasma cell neoplasm +1 | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00401544 | Dec 2006 → Dec 2007 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00443339 | Dec 2006 → Jul 2008 | myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Unknown | No outcome recorded |
| Phase 2 | NCT00398047 | Sep 2006 → Sep 2009 | leukemia, myelodysplastic syndrome | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT00359840 | Jul 2006 → Sep 2007 | anemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00334737 | Jun 2006 → Dec 2013 | — | University of New Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01039350 | Feb 2006 → Jul 2008 | myelodysplastic syndrome | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | Terminated | No outcome recorded |
| Phase 2 | NCT00239239 | Aug 2005 → Jan 2007 | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00144131 | Aug 2005 → ? | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00095264 | Oct 2004 → ? | myelodysplastic syndrome | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00095277 | Oct 2004 → ? | anemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00210002 | Nov 2003 → Apr 2006 | anemia, neoplasm | Institut Claudius Regaud | Terminated | No outcome recorded |
| Phase 2 | NCT00086086 | Aug 2003 → ? | anemia, congestive heart failure | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00146562 | Jul 2003 → May 2007 | breast cancer | Harold J. Burstein, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT00204633 | Jul 2003 → Dec 2008 | dysgerminoma | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 2 | NCT00058422 | Feb 2003 → Nov 2019 | lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00120705 | Nov 2002 → Sep 2003 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00121030 | Oct 2002 → Dec 2003 | anemia, female reproductive organ cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00120692 | Oct 2002 → Dec 2003 | anemia, breast cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00120679 | Oct 2002 → Dec 2003 | anemia, non-small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00049985 | Jul 2002 → ? | anemia, heart failure | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00989092 | May 2002 → Jan 2004 | anemia due to chronic disorder, carcinoma | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT00527215 | Mar 2002 → Oct 2003 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00035607 | Dec 2001 → Dec 2002 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00039884 | Sep 2001 → Mar 2003 | anemia, cervical cancer | Mirhashemi, Ramin, M.D. | Unknown | No outcome recorded |
| Phase 2 | NCT00540696 | Sep 2001 → Jun 2003 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00526929 | May 2000 → Feb 2002 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00036023 | — | B-cell chronic lymphocytic leukemia, breast neoplasm, lung neoplasm, plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00111462 | — | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT01197235 | May 2009 → Dec 2015 | acute kidney injury | Seoul National University Bundang Hospital | Terminated | No outcome recorded |
| Phase 2/3 | NCT00501917 | Mar 2007 → Feb 2010 | acute myocardial infarction | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT00381836 | Oct 2006 → Feb 2007 | anemia, prostate neoplasm | University of Aarhus | Terminated | No outcome recorded |
| Phase 346 trials | ||||||
| Phase 3 | NCT07169643 | Nov 2025 → Dec 2026 expected | — | Fundacion Clinic per a la Recerca Biomédica | Recruiting | No outcome recorded |
| Phase 3 | NCT05768997 | Mar 2023 → Dec 2025 | anemia | Hallym University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT05585645 | Aug 2019 → Nov 2022 | anemia, chronic kidney disease | Nanogen Pharmaceutical Biotechnology Joint Stock Company | Completed | No outcome recorded |
| Phase 3 | NCT04012957 | Jul 2019 → Aug 2021 | anemia, chronic kidney disease | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 3 | NCT03169881 | Sep 2017 → Dec 2022 | cognitive disorder, neurodevelopmental disorder | NICHD Neonatal Research Network | Completed | No outcome recorded |
| Phase 3 | NCT02988973 | Jan 2017 → Sep 2019 | chronic kidney disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02952092 | Nov 2016 → Mar 2018 | chronic kidney disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02506868 | Aug 2015 → Jan 2017 | anemia, end stage renal failure | Biocad | Completed | No outcome recorded |
| Phase 3 | NCT03431623 | May 2015 → Feb 2017 | anemia due to chronic disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT02175277 | Jun 2014 → Mar 2017 | myelodysplastic syndrome | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01652872 | Jul 2012 → Oct 2017 | — | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01581073 | Feb 2012 → Dec 2017 | chronic kidney disease, diabetes mellitus | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT01362140 | Dec 2011 → Feb 2015 | myelodysplastic syndrome | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00858364 | Jul 2009 → Jun 2017 | anemia, non-small cell lung carcinoma | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT01043991 | Dec 2008 → Jul 2010 | acute myocardial infarction | University Hospital, Montpellier | Completed | No outcome recorded |
| Phase 3 | NCT00579046 | Nov 2008 → Oct 2009 | anemia, chronic obstructive pulmonary disease | Assistance Publique - Hôpitaux de Paris | Withdrawn | No outcome recorded |
| Phase 3 | NCT00436748 | Sep 2008 → Mar 2014 | anemia, chronic kidney disease | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT00534456 | Jan → Oct 2007 | anemia, cardiac ventricle disorder, congestive heart failure | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT00358215 | Jun 2006 → Oct 2012 | anemia, cardiac ventricle disorder, congestive heart failure | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00436995 | Apr 2006 → Jan 2007 | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00344409 | Mar 2006 → May 2007 | anemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00661999 | Jan 2006 → Mar 2009 | anemia, cancer of unknown primary site, leukemia, lymphoproliferative syndrome +2 | Mayo Clinic | Completed | No outcome recorded |
| Phase 3 | NCT00116701 | May 2005 → ? | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00213291 | Apr → Sep 2005 | chronic renal failure syndrome | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 3 | NCT00121602 | Mar → Oct 2005 | anemia, chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00135317 | Nov 2004 → ? | cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00093977 | Oct 2004 → Jan 2007 | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00096915 | Oct 2004 → Nov 2005 | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00281892 | Sep 2004 → May 2008 | B-cell chronic lymphocytic leukemia, anemia | German CLL Study Group | Completed | No outcome recorded |
| Phase 3 | NCT00115167 | Aug 2004 → Jan 2007 | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00112008 | May 2004 → Mar 2005 | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00091858 | Apr 2004 → Oct 2006 | anemia, cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00111098 | Mar 2004 → Nov 2005 | kidney disorder | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00110955 | Feb 2004 → Mar 2005 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00144755 | Dec 2003 → Dec 2012 | diffuse large B-cell lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 3 | NCT00070382 | Aug → Nov 2003 | anemia, leukemia, lymphoproliferative syndrome, plasma cell neoplasm +1 | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00111137 | Feb → Nov 2003 | cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00119613 | Dec 2002 → Jan 2007 | small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00117624 | Dec 2002 → Dec 2003 | anemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00544232 | Aug 2002 → Sep 2006 | breast cancer | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00119587 | Aug 2002 → Sep 2003 | anemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00038064 | Jan 2002 → Oct 2003 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00527137 | Aug 2000 → Nov 2004 | end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03776032 | Sep 1999 → Nov 2000 | anemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00124098 | — | chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00148421 | — | anemia | Amgen | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT07523646 | May 2026 → Apr 2028 expected | anemia, infective endocarditis | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT07025460 | Dec 2019 → Oct 2024 overdue | chronic kidney disease | Gangnam Severance Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04959578 | Feb 2018 → Jan 2019 | anemia due to chronic disorder | Rufaida Mazahir | Completed | No outcome recorded |
| Phase 4 | NCT01306409 | Jan → Jul 2011 | anemia | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT00773513 | Dec 2008 → Jul 2017 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00117039 | Jan 2004 → Apr 2005 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00122720 | Jun 2003 → Jan 2006 | colorectal cancer | Herning Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00315484 | Feb 2003 → Oct 2004 | anemia | Ortho Biotech Products, L.P. | Completed | No outcome recorded |
| Phase 4 | NCT00117117 | Sep 2002 → Dec 2003 | anemia | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00369733 | May 2002 → Mar 2004 | chronic renal failure syndrome, end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00111995 | May 2002 → ? | anemia, chronic renal failure syndrome | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00369772 | Feb 2002 → May 2004 | chronic renal failure syndrome, end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00368901 | Jan 2002 → Mar 2004 | chronic renal failure syndrome, end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00117078 | — | kidney disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00117130 | — | kidney disorder | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00117104 | — | end stage renal failure | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT00117065 | — | anemia | Amgen | Completed | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT07568574 | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT07131280 | Sep 2025 → Jul 2031 expected | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT07002827 | Jun 2025 → Dec 2026 expected | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Recruiting | No outcome recorded |
| — | NCT00907608 | Dec 2007 → May 2009 | anemia, chronic kidney disease, diabetes mellitus | Chinese University of Hong Kong | Terminated | No outcome recorded |
| — | NCT00355407 | Jun 2006 → Aug 2007 | hematopoietic and lymphoid cell neoplasm | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| — | NCT00563446 | Jul 2005 → May 2006 | anemia, chronic renal failure syndrome | Hospital Authority, Hong Kong | Completed | No outcome recorded |
| — | NCT00309920 | Jan 2004 → ? | female breast carcinoma | Heinrich-Heine University, Duesseldorf | Unknown | No outcome recorded |
| — | NCT00283621 | Jun 2003 → Apr 2006 | sarcoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT00117234 | Sep 2002 → Jul 2004 | anemia, congestive heart failure | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 74 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03992066 Background | May 2019 → May 2020 | anemia due to chronic disorder | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02731469 Comparator | Jun 2016 → Mar 2017 | — | Biocad | Completed | No outcome recorded |
| Phase 1 | NCT03542916 Comparator | Oct → Nov 2014 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01363934 Comparator | Jun 2011 → Jul 2012 | — | Green Cross Corporation | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06917950 Comparator | Apr → Oct 2025 overdue | end stage renal failure, mixed anxiety and depressive disorder | Mansoura University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06903559 Comparator | Apr → Oct 2025 overdue | cardiovascular disorder, chronic renal failure syndrome, end stage renal failure, protein-energy malnutrition | Mansoura University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04798339 Background | Mar 2021 → May 2025 overdue | myelodysplastic syndrome | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01471015 Comparator | Sep 2012 → Jan 2014 | brain hypoxia - ischemia | University of Utah | Completed | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT05810311 Comparator | Jun 2025 → Jan 2027 expected | diabetic kidney disease | Region Stockholm | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05265325 Comparator | May 2023 → Feb 2024 | anemia | Kind Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 2 | NCT04432662 Comparator | May 2021 → Sep 2024 | — | Imperial College London | Unknown | No outcome recorded |
| Phase 2 | NCT03810911 Comparator | Jan 2021 → Dec 2024 | anemia, chronic kidney disease, hypertensive disorder | VA Office of Research and Development | Terminated | No outcome recorded |
| Phase 2 | NCT03446612 Comparator | Jan → May 2019 | anemia | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT02055482 Comparator | Jun 2014 → Nov 2016 | anemia, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02044653 Comparator | Apr 2014 → Apr 2017 | anemia, chronic kidney disease | Genexine, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02021409 Comparator | Jan 2014 → Oct 2015 | anemia, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01888445 Comparator | Mar 2013 → Sep 2014 | anemia due to chronic disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00968617 Comparator | Nov 2009 → Apr 2010 | anemia, chronic kidney disease | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2 | NCT01538771 Comparator | Nov 2009 → Sep 2012 | myocardial infarction | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00386152 Comparator | Nov 2006 → Mar 2008 | anemia, cancer | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | No outcome recorded |
| Phase 2 | NCT00375869 Comparator | Nov 2006 → Dec 2009 | traumatic brain injury | Royal Alexandra Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00327535 Comparator | May 2006 → May 2007 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00261313 Background | Dec 2005 → Jun 2007 | breast cancer | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00077311 Background | Aug 2004 → Jul 2006 | anemia, chemotherapy-induced toxicity, lung cancer, neutropenia | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00245895 Comparator | Apr 2003 → Feb 2005 | anemia, prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03104426 Comparator | Oct 2017 → Aug 2020 | Rh isoimmunization, fetal erythroblastosis, hemolytic disease of fetus and newborn, RH-induced | Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research | Unknown | No outcome recorded |
| Phase 2/3 | NCT00234143 Comparator | Oct 2004 → ? | myelodysplastic syndrome | St. Bartholomew's Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT00557817 Comparator | Mar 2004 → Aug 2008 | hematopoietic and lymphoid cell neoplasm | University of Liege | Completed | No outcome recorded |
| Phase 339 trials | ||||||
| Phase 3 | NCT07300111 Comparator | Dec 2025 → May 2027 expected | anemia | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06520826 Comparator | Nov 2024 → Jun 2026 overdue | anemia due to chronic disorder | USRC Kidney Research | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06466785 Comparator | Jan 2024 → Jun 2027 expected | anemia due to chronic disorder | Genexine, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04313153 Comparator | May 2020 → Nov 2021 | anemia | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT04027517 Comparator | Jan 2019 → Feb 2021 | anemia due to chronic disorder | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT03543657 Comparator | Jun 2018 → Aug 2019 | anemia, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT03439137 Comparator | Feb → Dec 2018 | anemia due to chronic disorder | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03350347 Comparator | Dec 2017 → Jul 2019 | anemia, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT03350321 Comparator | Dec 2017 → May 2019 | anemia, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT03329196 Comparator | Oct 2017 → Jan 2019 | anemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03242967 Comparator | Aug 2017 → Feb 2018 | anemia, chronic kidney disease | Akebia Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT03029208 Comparator | May 2017 → Sep 2020 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02969655 Comparator | Nov 2016 → Jul 2018 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02879305 Comparator | Sep 2016 → Nov 2020 | allergic bronchopulmonary aspergillosis, anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02876835 Comparator | Sep 2016 → Apr 2021 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02912494 Comparator | Sep 2016 → Sep 2017 | anemia | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02892149 Comparator | Aug 2016 → Jan 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02865850 Comparator | Jul 2016 → Jan 2020 | anemia, end stage renal failure | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02680574 Comparator | Feb 2016 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02648347 Comparator | Dec 2015 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03428594 Comparator | Jun 2015 → Jun 2017 | anemia due to chronic disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT02278341 Comparator | Nov 2014 → Jun 2017 | anemia, end stage renal failure | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT02021318 Comparator | Mar 2014 → Mar 2018 | aregenerative anemia | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01196715 Comparator | Nov 2010 → Oct 2015 | myelodysplastic syndrome | Barts & The London NHS Trust | Completed | No outcome recorded |
| Phase 3 | NCT00925587 Comparator | Jun 2009 → Apr 2012 | anemia, chronic kidney disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00717821 Comparator | Aug 2008 → Jul 2011 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00559273 Comparator | Dec 2007 → Oct 2009 | anemia due to chronic disorder | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00605345 Comparator | Dec 2007 → Jul 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00598442 Comparator | Nov 2007 → Jul 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 3 | NCT00598273 Comparator | Oct 2007 → Mar 2009 | anemia, chronic renal failure syndrome | Affymax | Completed | No outcome recorded |
| Phase 3 | NCT00442702 Comparator | Sep 2007 → Aug 2010 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00454246 Comparator | Apr 2007 → Feb 2008 | anemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT00394953 Comparator | Dec 2006 → Nov 2008 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00364845 Comparator | Sep 2006 → Dec 2008 | anemia, chronic kidney disease | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT00090753 Comparator | Oct 2004 → Dec 2009 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00093015 Comparator | Aug 2004 → Mar 2009 | anemia, chronic kidney disease, type 2 diabetes mellitus | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00081471 Comparator | Jun 2004 → Jul 2006 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00077766 Comparator | Mar 2004 → Aug 2005 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00118638 Comparator | Mar → Dec 2004 | anemia, neoplasm | Amgen | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05864261 Comparator | May → Aug 2023 | anemia | Yi Fang | Completed | No outcome recorded |
| Phase 4 | NCT01506947 Background | May 2012 → Apr 2016 | end stage renal failure, secondary hyperparathyroidism | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT02049346 Comparator | Mar 2012 → Apr 2013 | anemia due to chronic disorder | Hamad Medical Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02817555 Comparator | Sep 2010 → May 2013 | anemia, chronic kidney disease | Andrea L Woodland | Completed | No outcome recorded |
| Phase 4 | NCT00377481 Comparator | Sep 2006 → Jun 2007 | anemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00153868 Comparator | Oct 2003 → Aug 2007 | anemia, cancer | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01666301 Comparator | Feb 2010 → Apr 2012 | — | Ospedale Regionale di Locarno | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2016-02-15 | Amgen | Phase 3 Study Demonstrates Aranesp® (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS) amgen.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 208 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | darbepoetin alfa | “This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per...” NCT00144131 ↗165“The present study was designed to determine whether or not darbepoetin alfa is non-inferior to recombinant human erythropoietin in the treatment of anemia in children with...” NCT04959578 ↗ “A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection...” NCT05864261 ↗ “A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney...” NCT02988973 ↗ “rhEPO (epoetin alfa OR darbepoetin alfa) is commercially available in various single dose vials and single-dose prefilled syringes. It will be given as subcutaneous injection.” NCT03457701 ↗ “the test (CJ-40001) and reference (NESP®) versions of darbepoetin alfa following a single subcutaneous (SC) or intravenous (IV) administration in healthy male subjects.” PMID 30506495 ↗ Feb 2019 “Intervention in patients who prior has not been treated with EPO, will begin with 150 μg Darbepoetin alfa with weekly measurements of hemoglobin.” NCT07523646 ↗ “Patients receive azacitidine subcutaneously (SC) or intra-venous (IV) on days 1-5 (week 1) and darbepoetin alfa* SC on day 8 (week 2).” NCT00398047 ↗ “Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia.” PMID 18540943 ↗ Jun 2008 “epoetin alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialysis” PMID 34739194 ↗ Nov 2021 “Darbepoetin alfa will be administered every 3 weeks (21 days), at a starting dose of 300 ug (Dose Level 0).” NCT07096297 ↗ “Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)” NCT06520826 ↗ “Treatment: Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe” NCT05636891 ↗ “Study drug: Darbepoetin alfa (Aranesp) 500 microg every two weeks subcutaneously during 12 weeks” NCT00443339 ↗ “Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe” NCT05585645 ↗ “Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury” NCT00375869 ↗ “500 mcg of darbepoetin alfa subcutaneously every 3 weeks” NCT00281892 ↗ “Darbepoetin alfa, (also referred to as Aranesp or NESP)” NCT00245895 ↗ “BCD-066 is a darbepoetin alfa.” NCT03693950 ↗ “Comparator: darbepoetin alfa” NCT00968617 ↗ “Aranesp® (darbepoetin alfa)” NCT00124098 ↗ “Aranesp® (Darbepoetin Alfa)” NCT00111995 ↗ “darbepoetin alfa (NESP)” NCT00526929 ↗ |
| Known as | Aranesp | “This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per...” NCT00144131 ↗30“Aranesp® (Darbepoetin alfa 10 mcg/ 0.4 mL, 20 mcg/ 0.5 mL, 40 mcg/ 0.4 mL, 60 mcg/ 0.3 mL) is manufactured by Amgen, as a pre-filled syringe in a sterile, glass tube, colourless.” NCT05585645 ↗ “A Multicenter Study Evaluating Once Every Other Week Subcutaneous Administration of Aranesp (Darbepoetin Alfa) in Subjects With Anemia of Chronic Renal Insufficiency (CRI)” NCT00369772 ↗ “Darbepoetin (Aranesp) pre-filled syringes 500 mcg and filgrastim (Neupogen) pre-filled syringes 300 mcg will be supplied by Amgen (UK)and provided free of charge.” NCT00234143 ↗ “Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer” NCT00381836 ↗ “500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks” NCT00386152 ↗ “Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp)” NCT06520826 ↗ “Study drug: Darbepoetin alfa (Aranesp) 500 microg every two weeks subcutaneously during 12 weeks” NCT00443339 ↗ “A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen)” NCT02241200 ↗ “The control group will receive darbepoietin alpha (Aranesp) s.c. 0.45mg/kg once a week.” NCT05810311 ↗ “In the United States, darbepoetin alfa (Aranesp) is often used to” PMID 16478746 ↗ Feb 2006 “darbepoetin alfa (ARANESP; 200 mcg every other week)” NCT00315484 ↗ “darbepoetin-α (ARANESP®; Jeil-Kirin Pharm., Korea)” PMID 23506972 ↗ Mar 2013 “Darbepoetin alfa (Aranesp®)” NCT00210002 ↗ “Aranesp (darbepoetin alfa)” NCT00283621 ↗ “Darbepoetin Alfa (Aranesp)” NCT00355407 ↗ “darbepoetin alfa (Aranesp)” NCT00377481 ↗ “EPO Darbepoetin (Aranesp)” NCT07568574 ↗ |
| Known as | BCD-066 | “BCD-066 is a darbepoetin alfa.” NCT03693950 ↗1“BCD-066” NCT02506868 ↗ |
| Known as | CKD-11101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01684605 ↗ |
| Known as | Darbe | “Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule” NCT01471015 ↗ |
| Known as | darbepoetin | “The purpose of this study is to see if the treatment of severely brain injured patients with darbepoetin (a long acting form of erythropoietin) will be safe, and will reduce...” NCT00375869 ↗15“Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care,...” NCT01977573 ↗ “Standard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and/or intravenous iron...” NCT06903559 ↗ “Standard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and/or intravenous iron...” NCT06917950 ↗ “erythropoietic-stimulating agent, darbepoetin (Darbe), plus a slow-release intravenous (IV) iron preparation” PMID 41430711 ↗ Dec 2025 |
| Known as | Darbepoetin alpha | “Darbepoetin alpha (300 microg) or placebo was administered once per week for 4 weeks then every 3 weeks for up to six cycles of chemotherapy (carboplatin plus etoposide or...” PMID 18467726 ↗ May 20088“To determine whether or not Darbepoetin alpha (DA) was non-inferior to recombinant human erythropoietin (rHuEPO) in the treatment of anemia in children with chronic kidney...” PMID 36220980 ↗ Oct 2022 “AIM: To evaluate the ability of intracoronary administration of darbepoetin-alpha (DA) at the very onset of the reperfusion, to decrease infarct size (IS).” PMID 23582675 ↗ Feb 2013 “Darbepoetin alpha (Aranesp®) is produced by gene-technology in Chinese Hamster Cells (CHO-K1).” NCT00381836 ↗ “Darbepoetin alpha administered QM was well tolerated in study subjects.” PMID 17116009 ↗ Dec 2006 “Darbepoetin Alpha (10 mcg/kg) IV x2 doses following cooling therapy.” NCT04432662 ↗ “darbepoetin alpha (DA) for treating patients” PMID 18227526 ↗ Jan 2008 |
| Known as | darbepoetin-α | “darbepoetin-α (ARANESP®; Jeil-Kirin Pharm., Korea)” PMID 23506972 ↗ Mar 2013 |
| Known as | Darbepoietin alfa | “Darbepoietin alfa will be administered to these patients.” NCT02890602 ↗ |
| Known as | EPO | “Growth factors {like GCSF, darbepoetin (EPO) have shown survival benefits with improve liver repair and regeneration” NCT07131280 ↗ |
| Known as | KRN321 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01497145 ↗ |
| Known as | NESP | “A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) Using Fixed and Weight-Based Dosing for the Treatment of Anemia in Subjects...” NCT00111462 ↗13“A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection...” NCT05864261 ↗ “A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid...” NCT00038064 ↗ “An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)” NCT00540696 ↗ “Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)” NCT00540384 ↗ “Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP)” NCT00035607 ↗ “Darbepoetin alfa, (also referred to as Aranesp or NESP)” NCT00245895 ↗ “darbepoetin alfa (NESP)” NCT00526929 ↗ |
| Known as | Novel Erythropoiesis Stimulation Protein | “A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid...” NCT00038064 ↗ |
| Action | Activate | “including activation of the EPO receptor” NCT01471015 ↗ |
| Modality | Protein / enzyme biologic | “Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells.” NCT00035607 ↗ |
| Route | Subcutaneous | “Subcutaneous (SC) injection of darbepoetin alfa” NCT00035607 ↗ |