EPOGEN/PROCRIT (epoetin alfa)
EPOGEN/PROCRIT is indicated for the treatment of Anemia; Chronic Kidney Disease; Human Immunodeficiency Virus; Myelosuppression.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1989-06-01
- Patent Cliff
- 1997
- Routes
- SINGLE-USE, MULTIDOSE
- Dosage Forms
- VIAL
EPOGEN/PROCRIT Approval History
What EPOGEN/PROCRIT Treats
4 indicationsEPOGEN/PROCRIT is approved for 4 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
- Human Immunodeficiency Virus
- Myelosuppression
EPOGEN/PROCRIT 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 with chronic kidney disease (CKD) 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 i...
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 with chronic kidney disease (CKD) 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, E SA dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] . Use the lowest Epogen 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 ( 2.4 )] . Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.3 )] . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.5 )] . Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.4 )] . Perisurgery: Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] . 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 K
EPOGEN/PROCRIT Biosimilars
1 FDA-approvedThese 1 alternatives require prescriber approval to substitute for EPOGEN/PROCRIT.
What are biosimilars? Lower-cost alternatives to EPOGEN/PROCRIT with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
EPOGEN/PROCRIT 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.
Drugs Similar to EPOGEN/PROCRIT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
38 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07463820 | NCI-2026-01399 NCI-2026-01399, MM1MDS-CTG02 | Ph 2 | not yet recruiting | A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) |
| NCT05564390 | NCI-2022-07006 NCI-2022-07006, MYELOMATCH | Ph 2 | recruiting | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) |
| NCT05949684 ELEMENT-MDS | CA056-025 2022-500430-29-00 | Ph 3 | active not recruiting | ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions |
| NCT00843882 results posted | NCI-2009-01173 NCI-2009-01173, CDR0000634119 | Ph 3 | active not recruiting | Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia |
| NCT06832189 EVEREST | DAIT ITN101ST | Ph 1 | recruiting | EVR and EPO for Liver Transplant Tolerance |
| NCT07422480 ELRiSE MDS | TAK-226-3001 2025-523544-12-00 | Ph 3 | recruiting | A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions |
| NCT00560404 results posted | ML21208 | Ph 3 | completed | A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. |
| NCT05078138 results posted | 20-01H | Ph 4 | completed | Impact of Erythropoietin on Hematological Adaptations and Physical Performance |
| 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 |
| NCT03682536 COMMANDS results posted | ACE-536-MDS-002 U1111-1218-1810, 2022-501485-22 | Ph 3 | active not recruiting | A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve |
| NCT03079167 PAEAN | CTC0119 12614000669695 | Ph 3 | completed | PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns |
| NCT01685333 | EPOBLA0512IV-I2 Version 1 31/05/2012 | Ph 1 | completed | PK and PD Crossover Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects. |
| NCT01685359 | EPOBLA0612IV-I2 Version 1 25/06/2012 | Ph 1 | completed | PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant |
| NCT03799627 FO2RWARD-2 results posted | AKB-6548-CI-0025 | Ph 2 | completed | Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa |
| NCT01147666 results posted | FGCL-4592-040 | Ph 2 | completed | Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis |
| NCT04215120 DREAM-D | DESI.19.001.01 | Ph 3 | completed | Desidustat in the Treatment of Anemia in CKD on Dialysis Patients |
| NCT02273726 results posted | FGCL-4592-064 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis |
| NCT02052310 Himalayas results posted | FGCL-4592-063 2013-002753-30 | Ph 3 | completed | Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants |
| NCT03528564 HOPE-Hb | HOPE-Hb | Ph 2 | terminated | Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia |
| NCT03029247 results posted | 205665 | Ph 2 | completed | Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP) |
| NCT03140722 results posted | AKB-6548-CI-0018 | Ph 2 | terminated | Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents |
| 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 |
| NCT02174731 results posted | D5740C00002 | Ph 3 | completed | Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis. |
| 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) |
| NCT02920372 | IMIMFTCL/EPO 2016-002866-29 | Ph 1 | completed | Generation of Positive Biological Samples to Epoetin for Doping Control. |
| NCT02652806 | FGCL-4592-806 | Ph 3 | completed | FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease |
| NCT01034657 GEPARD results posted | CLBH589BDE04 EudraCT 2009-010403-84, 2009-010403-84 | Ph 2 | terminated | LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS) |
| NCT02253654 results posted | 20110208 | Ph 4 | completed | Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis |
| NCT00987454 EPO-TBI | ANZIC-RC/RB002 | Ph 3 | completed | Erythropoietin in Traumatic Brain Injury (EPO-TBI) |
| NCT00605293 results posted | ML21060 2007-002065-12 | Ph 3 | completed | A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia |
| NCT01374373 | BIOS-012010 | Ph 4 | completed | Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia |
| NCT01493973 FRIEMAX | FA_BBK_8 | Ph 2 | completed | Efficacy Study of Epoetin Alfa in Friedreich Ataxia |
| NCT01737879 results posted | 20110209 | Ph 4 | terminated | Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis |
| NCT01596855 | FGCL-4592-048 | Ph 2 | completed | Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China |
| NCT00695396 results posted | CR013651 EPOANE3018 | Ph 3 | terminated | A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion |
| NCT00680043 results posted | AFX01-15 | Ph 2 | completed | Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA |
| NCT00631202 | FA_EPO_3 | Ph 2 | completed | Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia |
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.
EPOGEN/PROCRIT FDA Label Details
Indications & Usage
FDA Label (PDF)EPOGEN/PROCRIT is indicated for the treatment of Anemia; Chronic Kidney Disease; Human Immunodeficiency Virus; Myelosuppression.
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 with chronic kidney disease (CKD) experienced greater risks for death, serious adv...
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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