ARANESP (darbepoetin alfa)
ARANESP is indicated for the treatment of Anemia due to chronic kidney disease in patients on dialysis; Anemia due to chronic kidney disease in patients not on dialysis; Anemia in patients with non-myeloid malignancies due to concomitant myelosuppressive chemotherapy.
How ARANESP Works
Aranesp acts as an erythropoiesis-stimulating agent to increase the production of red blood cells. It functions by stimulating erythropoiesis through the same biological mechanism as endogenous erythropoietin. By activating this process, the drug helps elevate red blood cell levels to treat anemia caused by kidney disease or chemotherapy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2001-09-17
- Revenue
- $357M (Q3-2025)
- Routes
- SUBCUTANEOUS, INTRAVENOUS
- Dosage Forms
- VIAL
ARANESP Approval History
What ARANESP Treats
3 indicationsARANESP is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia due to chronic kidney disease in patients on dialysis
- Anemia due to chronic kidney disease in patients not on dialysis
- Anemia in patients with non-myeloid malignancies due to concomitant myelosuppressive chemotherapy
ARANESP Boxed Warning
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [ see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target le...
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [ see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] . Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )] . Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non- small cell lung, head and neck, lymphoid, and cervical cancers [ see Warnings and Precautions ( 5.2 )] . To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.3 )] . Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.2 )]. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.3 )]. Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.3 )] . WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease : In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis - stimulating agents (ESAs) to ta
ARANESP Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ARANESP's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ARANESP treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
56 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03329196 results posted | MT-6548-J01 | Ph 3 | completed | Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan |
| NCT03439137 results posted | MT-6548-J03 | Ph 3 | completed | Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan |
| NCT05340465 DIVI | STUDY00015143 R01HD107003 | Ph 2 | recruiting | Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants |
| NCT07300111 | QLG1218-301 | Ph 3 | not yet recruiting | A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) |
| NCT04798339 | MCC-20552 CACZ885TUS02T | Ph 1, Ph 2 | active not recruiting | Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA |
| NCT07025460 | 3-2019-0358 | Ph 4 | active not recruiting | 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 |
| NCT04313153 results posted | 404-201-00012 AKB-6548-CI-0036, 2019-004851-36 | Ph 3 | completed | 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) |
| NCT02278341 Pyrenees results posted | 1517-CL-0613 2013-001497-16 | Ph 3 | completed | Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis |
| NCT02021318 Dolomites results posted | 1517-CL-0610 2013-000951-42 | Ph 3 | completed | Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa |
| NCT02952092 | 1517-CL-0307 | Ph 3 | completed | A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia |
| NCT01888445 | 1517-CL-0304 | Ph 2 | completed | 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 |
| NCT01471015 DANCE results posted | 49096 | Ph 1, Ph 2 | completed | Darbe Administration in Newborns Undergoing Cooling for Encephalopathy |
| NCT06466785 | GX-E4-CKD-002 | Ph 3 | recruiting | A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis |
| NCT02876835 results posted | 200808 2016-000542-65 | Ph 3 | completed | Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) |
| NCT03446612 results posted | 205767 2017-002268-42 | Ph 2 | terminated | Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) |
| NCT03071861 MEND results posted | MEND 16-330 | Ph 2 | completed | Mild Encephalopathy in the Newborn Treated With Darbepoetin |
| NCT00858364 results posted | 20070782 2007-005792-34 | Ph 3 | terminated | Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy |
| NCT00436748 results posted | 20050256 | Ph 3 | terminated | Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease |
| NCT01652872 START-CKD results posted | 20110226 | Ph 3 | completed | Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease |
| NCT02865850 results posted | AKB-6548-CI-0016 2016-000838-21 | Ph 3 | completed | 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) |
| NCT02892149 results posted | AKB-6548-CI-0017 2016-001360-11 | Ph 3 | completed | Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) |
| NCT02648347 results posted | AKB-6548-CI-0014 2015-004265-81 | Ph 3 | completed | Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease |
| NCT02680574 results posted | AKB-6548-CI-0015 2015-004774-14 | Ph 3 | completed | Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) |
| NCT04012957 DREAM-ND | DESI.18.001 | Ph 3 | completed | Desidustat in the Treatment of Anemia in CKD |
| NCT03029208 results posted | 201410 2016-000507-86 | Ph 3 | completed | Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID) |
| NCT00717821 | ML21145 | Ph 3 | completed | A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis. |
| NCT01506947 results posted | W12-645 | Ph 4 | completed | A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients |
| NCT04959578 | EC/01/18/1317 | Ph 4 | completed | Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease |
| NCT02241200 | DA3880_ANE_I | Ph 1 | completed | A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen) |
| NCT04027517 | JWP-JTZ-301 | Ph 3 | completed | A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis. |
| NCT03543657 MIYABI HD-M | 19352 | Ph 3 | completed | Maintenance Treatment of Renal Anemia in Dialysis Subjects |
| NCT03350321 MIYABI ND-C | 19349 | Ph 3 | completed | A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects |
| NCT03350347 MIYABI ND-M | 19350 | Ph 3 | completed | A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects |
| NCT02969655 results posted | 201754 | Ph 3 | completed | 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) |
| NCT03992066 | AKB-6548-CI-0034 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease |
| NCT02506868 results posted | BCD-066-2 | Ph 3 | completed | Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients |
| NCT03693950 results posted | BCD-066-3 | Ph 1 | completed | The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers |
| NCT02890602 | EPOMA | Ph 2 | completed | Erythropoietin for Management of Anemia Caused by Chemotherapy |
| NCT02021409 DIALOGUE 2 | 15261 2013-001192-21 | Ph 2 | completed | Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 |
| NCT02817555 results posted | HIC10.104 | Ph 4 | completed | Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients |
| NCT00773513 results posted | BH21260 2007-005129-31 | Ph 4 | completed | 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) |
| NCT02912494 | JR-131-301 | Ph 3 | completed | A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) |
| NCT02175277 results posted | 20130113 2013-000727-13 | Ph 3 | completed | Darbepoetin Alfa MDS Companion Protocol |
| NCT03242967 TRILOGY | AKB-6548-CI-0023 | Ph 3 | withdrawn | Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) |
| NCT01581073 PREDICT | TRIGU1115 UMIN000006616 | Ph 3 | completed | PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease |
| NCT01362140 results posted | 20090160 2009-016522-14 | Ph 3 | completed | Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) |
| NCT02049346 | 11021/11 | Ph 4 | completed | Comparison Among Erythropoietin Stimulating Agents |
| NCT00647998 DISC results posted | DISC-001 | Ph 2 | completed | The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial |
| NCT01428154 | 20090302 | Ph 1 | withdrawn | Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease |
| NCT02506881 results posted | BCD-066-1 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers |
Showing 50 of 56 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARANESP FDA Label Details
Indications & Usage
FDA Label (PDF)ARANESP is indicated for the treatment of Anemia due to chronic kidney disease in patients on dialysis; Anemia due to chronic kidney disease in patients not on dialysis; Anemia in patients with non-myeloid malignancies due to concomitant myelosuppressive chemotherapy.
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and...
Pro Intelligence Preview
Deep insights for ARANESP
Revenue Insights
- • Q3-2025: $357M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 58 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment