Aranesp

(darbepoetin alfa)

ApprovedBiologic

Darbepoetin alfa is used to treat anemia (low red blood cell count) in patients with chronic kidney disease or cancer patients receiving chemotherapy. It works by stimulating the body to produce more red blood cells.[2] Aranesp is currently approved and in use across 8 indications[4].[1]

Aranesp is one of 215 biologic programs targeting Diabetic Nephropathy. It is currently in Approved.

Indications

138

Total Trials

Active Trials

214

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Diabetic NephropathyActive, not recruiting

Anemia (phenotype)Unknown

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Colorectal CancerCompleted

Chronic Kidney DiseaseCompleted

MDSCompleted

InfantsRecruiting

Chronic Renal Failure SyndromeUnknown

Diabetic NephropathyPreclinical

Active, not recruiting

Anemia (phenotype)Preclinical

Unknown

Hematopoietic and Lymphoid Cell NeoplasmPreclinical

Active, not recruiting

Colorectal CancerApproved

Completed

Chronic Kidney DiseaseApproved

Completed

MDSPhase 3

Completed

InfantsPhase 2

Recruiting

Chronic Renal Failure SyndromePreclinical

Unknown

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 3

34 2

Keytruda

Merck & Co.

Phase 3

25 3

Aranesp

Amgen

Approved

1 4

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

8 5

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

4 6

Mfolfox6

Roche

Phase 3

5 7

Botensilimab

AAgenus Inc.

Phase 3

9 8

Balstilimab

AAgenus Inc.

Phase 3

9 9

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 10

Serplulimab

Shanghai Henlius Biotech

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Infants

NCT05340465

Q3 2027

Phase 3Not yet recruiting

Chronic Kidney Disease

NCT07300111

Phase 3Recruiting

Chronic Kidney Disease

NCT06466785

Phase 2Recruiting

Anemia Associated With Chronic Kidney Disease

NCT07854561

Clinical

Trials by Indication[1]

Chronic Kidney Disease40 trials

Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT03329196·304 enrolled

Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

Completed· Amgen logo

Amgen·Phase 3·NCT00925587·358 enrolled

Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Withdrawn·AAkebia Therapeutics·Phase 3·NCT03242967

Show 37 more trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02680574·1,725 enrolled

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Completed· GSK logo

GSK·Phase 3·NCT02876835·3,872 enrolled

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Completed· Roche logo

Roche·Phase 3·NCT00090753·1,228 enrolled

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

Completed· Roche logo

Roche·Phase 3·NCT00559273·307 enrolled

A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)

Completed· GSK logo

GSK·Phase 3·NCT02969655·271 enrolled

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Terminated· GSK logo

GSK·Phase 2·NCT03446612·6 enrolled

Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT03439137·323 enrolled

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Completed· Astellas logo

Astellas·Phase 3·NCT02021318·616 enrolled

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02865850·369 enrolled

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02892149·3,554 enrolled

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

Completed·AAkebia Therapeutics·Phase 3·NCT02648347·1,751 enrolled

Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

Completed·BBiocad·Phase 3·NCT02506868·196 enrolled

Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.

Completed·—··NCT02987465·29 enrolled

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Completed· Roche logo

Roche·Phase 3·NCT00442702·228 enrolled

A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)

Not yet recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT07300111·100 enrolled

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Completed· Roche logo

Roche·Phase 4·NCT00773513·2,825 enrolled

Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

Completed· Bayer logo

Bayer·Phase 2·NCT02021409·126 enrolled

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 recruiting·GGangnam Severance Hospital·Phase 4·NCT07025460·40 enrolled

Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

Completed· Amgen logo

Amgen·Phase 3·NCT00436995·114 enrolled

Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

Completed· Amgen logo

Amgen·Phase 3·NCT00096915·110 enrolled

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

Completed· Astellas logo

Astellas·Phase 2·NCT01888445·130 enrolled

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

Completed· GSK logo

GSK·Phase 3·NCT03029208·312 enrolled

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease

Completed·AAkebia Therapeutics·Phase 1·NCT03992066·46 enrolled

Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease

Completed·RRufaida Mazahir·Phase 4·NCT04959578·50 enrolled

STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

Terminated· Amgen logo

Amgen·Phase 3·NCT00364845·51 enrolled

A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting·GGenexine, Inc.·Phase 3·NCT06466785·429 enrolled

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

Completed· Roche logo

Roche·Phase 3·NCT00717821·421 enrolled

A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Completed· Roche logo

Roche·Phase 3·NCT00081471·324 enrolled

Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis

Completed· Amgen logo

Amgen·Phase 3·NCT00111098·150 enrolled

A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 3·NCT02912494

Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

Completed· Amgen logo

Amgen·Phase 3·NCT00121602·446 enrolled

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Completed· Amgen logo

Amgen·Phase 3·NCT01652872·756 enrolled

Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease

Completed·UUniversity of Maryland, Baltimore··NCT00883415·20 enrolled

Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

Withdrawn· Amgen logo

Amgen·Phase 1·NCT01428154

A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

Completed· Astellas logo

Astellas·Phase 3·NCT02952092·303 enrolled

Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Terminated· Amgen logo

Amgen·Phase 3·NCT00436748·116 enrolled

PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 3·NCT01581073·476 enrolled

Anemia38 trials

A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

Completed· Roche logo

Roche·Phase 3·NCT00394953·490 enrolled

Maintenance Treatment of Renal Anemia in Dialysis Subjects

Completed· Bayer logo

Bayer·Phase 3·NCT03543657·229 enrolled

A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

Completed· Bayer logo

Bayer·Phase 3·NCT03350321·162 enrolled

Show 35 more trials

Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

Completed· Amgen logo

Amgen·Phase 2·NCT00121030

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)

Completed·AAkebia Therapeutics·Phase 3·NCT04313153·319 enrolled

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

Completed·AAffymax·Phase 3·NCT00598442·493 enrolled

COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

Completed· Roche logo

Roche·Phase 4·NCT00377481·48 enrolled

A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT00344409·200 enrolled

Treatment for Patients Suffering From Anemia Due to Chemotherapy

Completed· Amgen logo

Amgen·Phase 2·NCT00120692

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy

Completed·MMayo Clinic·Phase 2·NCT00416624·239 enrolled

A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.

Completed·JJW Pharmaceutical·Phase 3·NCT04027517·172 enrolled

Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00091858·1,000 enrolled

Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients

Completed·AAndrea L Woodland·Phase 4·NCT02817555·50 enrolled

Darbepoetin Alfa and Anemia of Cancer

Terminated· Amgen logo

Amgen·Phase 2·NCT00989092·287 enrolled

Completed· Amgen logo

Amgen·Phase 2·NCT00036023

Cost-effectiveness Study of Epoetin Alfa and Darbepoetin Alfa in Adult Patients With Cancer Who Have Anemia

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT00264108·492 enrolled

Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Completed· Amgen logo

Amgen·Phase 3·NCT00110955·391 enrolled

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

Completed· Roche logo

Roche·Phase 3·NCT00077766·313 enrolled

Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Completed·JJonsson Comprehensive Cancer Center·Phase 3·NCT00070382·14 enrolled

AIM 3: Anemia and Iron Management With Every 3 Week Dosing in Anemic Subjects With Nonmyeloid Malignancies

Completed· Amgen logo

Amgen·Phase 3·NCT00135317

A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects

Completed· Bayer logo

Bayer·Phase 3·NCT03350347·164 enrolled

Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

Completed·AAffymax·Phase 3·NCT00598273·490 enrolled

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Completed· Astellas logo

Astellas·Phase 3·NCT02278341·838 enrolled

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Completed· Amgen logo

Amgen·Phase 3·NCT00118638·705 enrolled

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Unknown status·HHallym University Medical Center·Phase 3·NCT05768997·312 enrolled

Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

Completed·TThe Hospital for Sick Children·Phase 3·NCT00213291·40 enrolled

Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

Completed· Amgen logo

Amgen·Phase 2·NCT00239239·44 enrolled

Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia

Completed·HHospital Authority, Hong Kong·N/A·NCT00563446·16 enrolled

Desidustat in the Treatment of Anemia in CKD

Completed·ZZydus Lifesciences Limited·Phase 3·NCT04012957·588 enrolled

Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

Terminated·FFundacion para el Estudio de la Hematologia y Hemoterapia en Aragon·Phase 2·NCT01039350·80 enrolled

Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Completed· Amgen logo

Amgen·Phase 2·NCT00095277·220 enrolled

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

Completed·MMayo Clinic·Phase 3·NCT00661999·502 enrolled

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

Completed· Amgen logo

Amgen·Phase 3·NCT00117624

A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT00359840·120 enrolled

Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

Completed· Amgen logo

Amgen·Phase 2·NCT00111462

Erythropoietin for Management of Anemia Caused by Chemotherapy

Completed·KKosin University Gospel Hospital·Phase 2·NCT02890602·53 enrolled

Anemia in Patients With a Non-Myeloid Malignancy

Completed· Amgen logo

Amgen·Phase 3·NCT00038064·707 enrolled

Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

Completed· Amgen logo

Amgen·Phase 3·NCT00119587

Non-Small Cell Lung Cancer4 trials

A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

Completed· Roche logo

Roche·Phase 2·NCT00327535·153 enrolled

Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

Completed· Amgen logo

Amgen·Phase 2·NCT00120679

Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

Terminated· Amgen logo

Amgen·Phase 3·NCT00858364·2,549 enrolled

Show 1 more trial

Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00077311·160 enrolled

Myelodysplastic Syndrome4 trials

A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

Completed·PPeter L Greenberg·Phase 1/2·NCT00230321·21 enrolled

Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Completed· Amgen logo

Amgen·Phase 3·NCT01362140·147 enrolled

Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01222195·1 enrolled

Show 1 more trial

A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Completed· Amgen logo

Amgen·Phase 2·NCT00095264·209 enrolled

Erythropoietin3 trials

A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

Completed· AbbVie logo

AbbVie·Phase 4·NCT01506947·65 enrolled

Comparison Among Erythropoietin Stimulating Agents

Completed·HHamad Medical Corporation·Phase 4·NCT02049346·327 enrolled

To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin

Completed·GGreen Cross Corporation·Phase 1·NCT01363934·100 enrolled

32 more indications

Encephalopathy3 trials

Darbe Administration in Newborns Undergoing Cooling for Encephalopathy

Completed·UUniversity of Utah·Phase 1/2·NCT01471015·30 enrolled

Darbepoetin in Neonatal Encephalopathy Trial

Recruiting·IImperial College London·Phase 2·NCT04432662·150 enrolled

Mild Encephalopathy in the Newborn Treated With Darbepoetin

Completed·UUniversity of New Mexico·Phase 2·NCT03071861·28 enrolled

Heart Failure3 trials

An Exploratory Sub-study for the RED-HF™ (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial

Terminated· Amgen logo

Amgen·Phase 3·NCT00534456·12 enrolled

Heart Failure and Anemia

Completed· Amgen logo

Amgen·Phase 2·NCT00049985·300 enrolled

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

Completed· Amgen logo

Amgen·Phase 3·NCT00358215·2,278 enrolled

Congestive Heart Failure3 trials

A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

Completed· Amgen logo

Amgen·Phase 1/2·NCT00117247

Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia

Completed· Amgen logo

Amgen·N/A·NCT00117234

Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

Completed· Amgen logo

Amgen·Phase 2·NCT00086086·150 enrolled

Myeloid Malignancies3 trials

Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

Completed· Amgen logo

Amgen·Phase 2·NCT00540696·300 enrolled

Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Completed· Amgen logo

Amgen·Phase 3·NCT00111137·718 enrolled

Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

Completed· Amgen logo

Amgen·Phase 2·NCT00120705·204 enrolled

Breast Cancer2 trials

Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

Unknown status·HHeinrich-Heine University, Duesseldorf·N/A·NCT00309920·1,234 enrolled

Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

Completed·—·Phase 2·NCT00146562·135 enrolled

MDS2 trials

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT04798339·13 enrolled

Darbepoetin Alfa MDS Companion Protocol

Completed· Amgen logo

Amgen·Phase 3·NCT02175277·9 enrolled

Chemotherapy2 trials

A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy

Terminated· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00386152·235 enrolled

A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

Completed· Amgen logo

Amgen·Phase 3·NCT00115167·371 enrolled

Infants2 trials

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Recruiting·UUniversity of Washington·Phase 2·NCT05340465·120 enrolled

Darbepoetin Administration to Preterm Infants

Completed·UUniversity of New Mexico·Phase 2·NCT00334737·102 enrolled

Lung Cancer2 trials

A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

Completed· Amgen logo

Amgen·Phase 3·NCT03776032·320 enrolled

A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Completed· Amgen logo

Amgen·Phase 3·NCT00119613·600 enrolled

Diffuse Large B-Cell Lymphoma1 trial

R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma

Completed·LLymphoma Study Association·Phase 3·NCT00144755·600 enrolled

ARB1 trial

Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling

Completed·SSeoul National University Bundang Hospital·Phase 2·NCT01538771·80 enrolled

Quality of Life1 trial

A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer

Completed·—·Phase 4·NCT00153868·43 enrolled

Kidney Transplant1 trial

A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

Completed· Roche logo

Roche·Phase 3·NCT00605345·71 enrolled

Hemoglobin1 trial

A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

Terminated· Roche logo

Roche·Phase 3·NCT00454246·111 enrolled

Germ Cell Tumor1 trial

Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

Completed·UUniversity Hospital Tuebingen·Phase 2·NCT00204633·108 enrolled

Cardiovascular Events1 trial

Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

Completed· Amgen logo

Amgen·Phase 3·NCT00093015·4,038 enrolled

Stroke1 trial

Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

Unknown status·UUMC Utrecht·Phase 2·NCT03171818·80 enrolled

Colorectal Cancer1 trial

The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

Completed·—·Phase 4·NCT00122720·200 enrolled

Intravenous1 trial

Darbepoetin Alfa With or Without Intravenous (IV) Iron

Completed· Amgen logo

Amgen·Phase 2·NCT00401544·243 enrolled

Prophylaxis1 trial

Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

Terminated·IInstitut Claudius Regaud·Phase 2·NCT00210002·55 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

Withdrawn·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00579046

Prostate Cancer1 trial

Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer

Terminated·UUniversity of Aarhus·Phase 2/3·NCT00381836·140 enrolled

CAR1 trial

Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"

Completed·UUniversity Hospital, Montpellier·Phase 3·NCT01043991·54 enrolled

Tics1 trial

Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers

Completed·BBiocad·Phase 1·NCT02506881·74 enrolled

Allogeneic Stem Cell Transplantation1 trial

Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Completed·—·N/A·NCT00355407·31 enrolled

Phase 21 trial

Phase 2 Study of Darbepoetin Alfa Extended Dosing

Completed· Amgen logo

Amgen·Phase 2·NCT00527215·98 enrolled

Diabetic Nephropathy1 trial

A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

Terminated·—·N/A·NCT00907608·16 enrolled

Lymphoma1 trial

Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00058422·65 enrolled

Pediatric1 trial

NESP Pediatric Study

Completed· Amgen logo

Amgen·Phase 3·NCT00527137·120 enrolled

Complication1 trial

The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial

Completed·UUniversity of Pennsylvania·Phase 2·NCT00647998·18 enrolled

Anemia Associated With Chronic Kidney Disease1 trial

A Clinical Trial to Evaluate the Safety of the Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents (ESAs) in ESA-resistant Anemic Patients

Recruiting·CChinese University of Hong Kong·Phase 2·NCT07854561·12 enrolled

Unspecified5 trials

STAAR-2 Clinical Study

Completed· Amgen logo

Amgen·Phase 4·NCT00368901·618 enrolled

Fixed Dose NESP Study in Subjects With CRI

Completed· Amgen logo

Amgen·Phase 2·NCT00526929·75 enrolled

EPO-4-Rhesus Study

Unknown status·SSanquin-LUMC J.J van Rood Center for Clinical Transfusion Research·Phase 2/3·NCT03104426·42 enrolled

Show 2 more trials

STAAR-3 Clinical Study

Completed· Amgen logo

Amgen·Phase 4·NCT00369733·443 enrolled

STAAR-1 Clinical Study

Completed· Amgen logo

Amgen·Phase 4·NCT00369772·2,000 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 17, 2001

ARANESP

NDA BLA103951

Sep 17, 2001

ARANESP

BLA BLA103951

Jul 19, 2002

ARANESP

NDA BLA103951

Nov 18, 2004

ARANESP

NDA BLA103951

Dec 16, 2004

ARANESP

NDA BLA103951

Mar 24, 2005

ARANESP

NDA BLA103951

Oct 26, 2005

ARANESP

NDA BLA103951

Dec 15, 2005

ARANESP

NDA BLA103951

Mar 23, 2006

ARANESP

NDA BLA103951

Mar 9, 2007

ARANESP

NDA BLA103951

Apr 10, 2007

ARANESP

NDA BLA103951

Nov 8, 2007

ARANESP

NDA BLA103951

Nov 13, 2007

ARANESP

NDA BLA103951

Dec 17, 2007

ARANESP

NDA BLA103951

Mar 7, 2008

ARANESP

NDA BLA103951

May 5, 2008

ARANESP

NDA BLA103951

Nov 19, 2008

ARANESP

NDA BLA103951

Oct 13, 2009

ARANESP

NDA BLA103951

Jan 11, 2010

ARANESP

NDA BLA103951

Feb 16, 2010

ARANESP

NDA BLA103951

Jun 24, 2011

ARANESP

NDA BLA103951

Jun 24, 2011

ARANESP

NDA BLA103951

Jun 24, 2011

ARANESP

NDA BLA103951

May 31, 2012

ARANESP

NDA BLA103951

Mar 27, 2013

ARANESP

NDA BLA103951

Dec 31, 2013

ARANESP

NDA BLA103951

Dec 31, 2013

ARANESP

NDA BLA103951

Apr 17, 2014

ARANESP

NDA BLA103951

Jul 23, 2015

ARANESP

NDA BLA103951

Apr 27, 2016

ARANESP

NDA BLA103951

Apr 13, 2017

ARANESP

NDA BLA103951

Oct 31, 2017

ARANESP

NDA BLA103951

Dec 20, 2018

ARANESP

NDA BLA103951

Jan 30, 2019

ARANESP

NDA BLA103951

Apr 30, 2024

ARANESP

NDA BLA103951

Sources

References

[1]
ClinicalTrials.gov — 138 trial records for darbepoetin alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aranesp drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — darbepoetin alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for darbepoetin alfa. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA103951). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Erythropoietin Receptor Agonist[3]
Modality: Biologic[3]
Highest Phase: Approved[1]
Company: Amgen

Aranesp

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Chronic Kidney Disease40 trials

Anemia38 trials

Non-Small Cell Lung Cancer4 trials

Myelodysplastic Syndrome4 trials

Erythropoietin3 trials

Encephalopathy3 trials

Heart Failure3 trials

Congestive Heart Failure3 trials

Myeloid Malignancies3 trials

Breast Cancer2 trials

MDS2 trials

Chemotherapy2 trials

Infants2 trials

Lung Cancer2 trials

Diffuse Large B-Cell Lymphoma1 trial

ARB1 trial

Quality of Life1 trial

Kidney Transplant1 trial

Hemoglobin1 trial

Germ Cell Tumor1 trial

Cardiovascular Events1 trial

Stroke1 trial

Colorectal Cancer1 trial

Intravenous1 trial

Prophylaxis1 trial

Chronic Obstructive Pulmonary Disease1 trial

Prostate Cancer1 trial

CAR1 trial

Tics1 trial

Allogeneic Stem Cell Transplantation1 trial

Phase 21 trial

Diabetic Nephropathy1 trial

Lymphoma1 trial

Pediatric1 trial

Complication1 trial

Anemia Associated With Chronic Kidney Disease1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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