Darbepoetin alfa

Overview

Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Indication

For the treatment of anemia (from renal transplants or certain HIV treatment)

Associated Conditions

Anemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis	2025/08/20	NCT07131280	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
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, Multicenter, Phase 4 Study	2025/06/17	NCT07025460	Phase 4	Active, not recruiting	Gangnam Severance Hospital
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.	2025/06/04	NCT07002827	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis	2024/06/20	NCT06466785	Phase 3	Recruiting	Genexine, Inc.
Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers	2023/05/18	NCT05864261	Phase 4	Completed	Yi Fang
High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia	2023/03/15	NCT05768997	Phase 3	Recruiting	Hallym University Medical Center
Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants	2022/04/22	NCT05340465	Phase 2	Recruiting	University of Washington
A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis	2022/03/03	NCT05265325	Phase 2	Completed	Kind Pharmaceuticals LLC
Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease	2021/07/13	NCT04959578	Phase 4	Completed	Rufaida Mazahir
Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA	2021/03/15	NCT04798339	Phase 1	Active, not recruiting	H. Lee Moffitt Cancer Center and Research Institute

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Aranesp	Amgen Europe B.V.,Minervum 7061,NL-4817 ZK Breda,The Netherlands	Authorised	6/8/2001

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NESP INJECTION PLASTIC SYRINGE 60 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14743P	INJECTION, SOLUTION, CONCENTRATE	60 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 180 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14745P	INJECTION, SOLUTION, CONCENTRATE	180 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 120 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14744P	INJECTION, SOLUTION, CONCENTRATE	120 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 30 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14741P	INJECTION, SOLUTION, CONCENTRATE	30 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 10 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14739P	INJECTION, SOLUTION, CONCENTRATE	10 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 20 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14740P	INJECTION, SOLUTION, CONCENTRATE	20 μg	3/2/2015
NESP INJECTION PLASTIC SYRINGE 40 μg/0.5 ml	Terumo Corporation (Kofu Factory)	SIN14742P	INJECTION, SOLUTION, CONCENTRATE	40 μg	3/2/2015

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
NESP INJECTION PLASTIC SYRINGE 40MCG/0.5ML	N/A	DKSH Hong Kong Limited	N/A	N/A	8/25/2014
NESP INJECTION PLASTIC SYRINGE 180MCG/0.5ML	N/A	DKSH Hong Kong Limited	N/A	N/A	8/25/2014
NESP INJECTION PLASTIC SYRINGE 20MCG/0.5ML	N/A	DKSH Hong Kong Limited	N/A	N/A	8/25/2014
NESP INJECTION PLASTIC SYRINGE 120MCG/0.5ML	N/A	DKSH Hong Kong Limited	N/A	N/A	8/25/2014

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ARANESP darbepoetin alfa (rch) 20 microgram/0.5mL injection syringe within a pen injector	122853	Amgen Australia Pty Ltd	Medicine	A	6/7/2006
ARANESP darbepoetin alpha (rch) 60 microgram/0.3mL injection syringe within a pen injector	122849	Amgen Australia Pty Ltd	Medicine	A	6/7/2006
ARANESP darbepoetin alfa (rch) 50 microgram/0.5mL injection syringe	77955	Amgen Australia Pty Ltd	Medicine	A	7/13/2001
ARANESP darbepoetin alfa (rch) 40 microgram/0.4mL injection syringe with automatic needle guard	166094	Amgen Australia Pty Ltd	Medicine	A	6/17/2010
ARANESP darbepoetin alpha (rch) 60 microgram/0.3mL injection syringe with automatic needle guard	166688	Amgen Australia Pty Ltd	Medicine	A	6/17/2010
ARANESP darbepoetin alfa (rch) 300 microgram/0.6mL injection syringe with automatic needle guard	166093	Amgen Australia Pty Ltd	Medicine	A	6/17/2010
ARANESP darbepoetin alfa (rch) 10 microgram/0.4mL injection syringe within a pen injector	122848	Amgen Australia Pty Ltd	Medicine	A	6/7/2006
ARANESP darbepoetin alfa (rch) 150 microgram/0.3mL injection syringe within a pen injector	122854	Amgen Australia Pty Ltd	Medicine	A	6/7/2006
ARANESP darbepoetin alfa (rch) 15 microgram/0.38mL injection syringe within a pen injector	122858	Amgen Australia Pty Ltd	Medicine	A	6/7/2006
ARANESP darbepoetin alfa (rch) 500 microgram/1.0mL solution for injection syringe	91948	Amgen Australia Pty Ltd	Medicine	A	11/26/2002

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ARANESP	Amgen Canada Inc	02391813	Solution - Subcutaneous , Intravenous	500 MCG / ML	N/A
ARANESP	Amgen Canada Inc	02392313	Solution - Intravenous , Subcutaneous	25 MCG / ML	8/16/2013
ARANESP	Amgen Canada Inc	02391791	Solution - Intravenous , Subcutaneous	500 MCG / ML	4/21/2014
ARANESP	Amgen Canada Inc	02392364	Solution - Intravenous , Subcutaneous	500 MCG / ML	2/24/2014
ARANESP	Amgen Canada Inc	02392356	Solution - Subcutaneous , Intravenous	200 MCG / ML	4/3/2014
ARANESP -(HSA-FREE)	Amgen Canada Inc	02246360	Solution - Intravenous , Subcutaneous	500 MCG / ML	8/13/2002
ARANESP -(HSA-FREE)	Amgen Canada Inc	02246355	Solution - Intravenous , Subcutaneous	40 MCG / ML	8/13/2002
ARANESP -(HSA-FREE)	Amgen Canada Inc	02246357	Solution - Intravenous , Subcutaneous	100 MCG / ML	8/20/2002
ARANESP	Amgen Canada Inc	02391805	Solution - Subcutaneous , Intravenous	500 MCG / ML	5/5/2014
ARANESP	Amgen Canada Inc	02246359	Solution - Intravenous , Subcutaneous	325 MCG / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ARANESP 300 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	01185096	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 40 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	01185083	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 80 microgramos SOLUCION INYECTABLE EN PLUMA PRECARGADA	Amgen Europe B.V.	01185052	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 500 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	01185031	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Uso Hospitalario	Not Commercialized
ARANESP 300 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	01185021	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Uso Hospitalario	Not Commercialized
ARANESP 150 microgramos SOLUCION INYECTABLE EN PLUMA PRECARGADA	Amgen Europe B.V.	01185054	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 100 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADA	Amgen Europe B.V.	01185018	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Uso Hospitalario	Not Commercialized
ARANESP 40 microgramos SOLUCION INYECTABLE EN PLUMA PRECARGADA	Amgen Europe B.V.	01185049	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 500 microgramos SOLUCION INYECTABLE EN PLUMA PRECARGADA	Amgen Europe B.V.	01185056	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Commercialized
ARANESP 130 microgramos SOLUCION INYECTABLE EN PLUMA PRECARGADA	Amgen Europe B.V.	01185072	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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