epoetin alfa

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
EVR and EPO for Liver Transplant Tolerance	2025/02/18	NCT06832189	Phase 1	Not yet recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes	2024/08/30	NCT06581055	N/A	Withdrawn	Bristol-Myers Squibb
ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions	2023/07/18	NCT05949684	Phase 3	Recruiting	Bristol-Myers Squibb
Hydroxyurea and EPO in Sickle Cell Disease	2022/07/11	NCT05451940	Phase 1	Completed	Julia Xu
Impact of Erythropoietin on Hematological Adaptations and Physical Performance	2021/10/14	NCT05078138	Phase 4	Completed	United States Army Research Institute of Environmental Medicine
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients	2020/01/02	NCT04215120	Phase 3	Completed	Zydus Lifesciences Limited
Evaluate the Efficacy and Safety of HIF-PHI for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in ESRD Newly Initiated Dialysis Patients	2019/10/21	NCT04134026	Phase 4	Not yet recruiting	Second Xiangya Hospital of Central South University
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease	2019/06/19	NCT03992066	Phase 1	Completed	Akebia Therapeutics
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa	2019/01/10	NCT03799627	Phase 2	Completed	Akebia Therapeutics
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	2018/09/24	NCT03682536	Phase 3	Active, not recruiting	Celgene

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
RETACRIT	Vifor (International) Inc.	59353-004	INTRAVENOUS, SUBCUTANEOUS	4000 [iU] in 1 mL	5/12/2023
EPOGEN	Amgen Inc	55513-267	INTRAVENOUS, SUBCUTANEOUS	3000 [iU] in 1 mL	7/25/2018
RETACRIT	Pfizer Laboratories Div Pfizer Inc	0069-1309	INTRAVENOUS, SUBCUTANEOUS	40000 [iU] in 1 mL	4/1/2023
RETACRIT	Vifor (International) Inc.	59353-002	INTRAVENOUS, SUBCUTANEOUS	2000 [iU] in 1 mL	5/12/2023
RETACRIT	Vifor (International) Inc.	59353-003	INTRAVENOUS, SUBCUTANEOUS	3000 [iU] in 1 mL	5/12/2023
EPOGEN	Amgen Inc	55513-148	INTRAVENOUS, SUBCUTANEOUS	4000 [iU] in 1 mL	7/25/2018
RETACRIT	Pfizer Laboratories Div Pfizer Inc	0069-1318	INTRAVENOUS, SUBCUTANEOUS	10000 [iU] in 1 mL	4/1/2023
EPOGEN	Amgen Inc	55513-126	INTRAVENOUS, SUBCUTANEOUS	2000 [iU] in 1 mL	7/25/2018
EPOGEN	Amgen Inc	55513-144	INTRAVENOUS, SUBCUTANEOUS	10000 [iU] in 1 mL	7/25/2018
RETACRIT	Vifor (International) Inc.	59353-120	INTRAVENOUS, SUBCUTANEOUS	20000 [iU] in 1 mL	5/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Epoetin Alfa Hexal	Hexal AG,Industriestrasse 25,D-83607 Holzkirchen,Germany	Authorised	8/27/2007
Epoetin Alfa Hexal	Hexal AG,Industriestrasse 25,D-83607 Holzkirchen,Germany	Authorised	8/27/2007
Binocrit	Sandoz GmbH,Biochemiestrasse 10,AT-6250 Kundl,Austria	Authorised	8/28/2007
Abseamed	Medice Arzneimittel Pütter GmbH Co. KG,Kuhloweg 37-39,D-58638 Iserlohn,Germany	Authorised	8/27/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EPREX epoetin alfa (rch) 40000IU/mL injection syringe	73487	Janssen-Cilag Pty Ltd	Medicine	A	9/4/2000
EPREX epoetin alfa (rch) 5000IU/0.5mL injection syringe	76970	Janssen-Cilag Pty Ltd	Medicine	A	12/21/2000
EPREX epoetin alfa 10000IU/1.0mL injection syringe	65446	Janssen-Cilag Pty Ltd	Medicine	A	9/17/1998
EPREX epoetin alfa 2000IU/0.5mL injection syringe	65443	Janssen-Cilag Pty Ltd	Medicine	A	9/17/1998
EPREX epoetin alfa 3000IU/0.3mL injection syringe	65444	Janssen-Cilag Pty Ltd	Medicine	A	9/17/1998
EPREX epoetin alfa (rch) 8000IU/0.8mL injection syringe	76973	Janssen-Cilag Pty Ltd	Medicine	A	12/21/2000
EPREX epoetin alfa (rch) 20000IU/0.5mL injection syringe	73486	Janssen-Cilag Pty Ltd	Medicine	A	9/4/2000
EPREX epoetin alfa 4000IU/0.4mL injection syringe	65445	Janssen-Cilag Pty Ltd	Medicine	A	9/17/1998
EPREX epoetin alfa (rch) 30000IU/0.75mL injection syringe	135069	Janssen-Cilag Pty Ltd	Medicine	A	1/14/2008
EPREX epoetin alfa 1000IU/0.5mL injection syringe	65442	Janssen-Cilag Pty Ltd	Medicine	A	9/17/1998

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The COMMANDS trial reveals luspatercept's superior long-term efficacy over epoetin alfa in achieving transfusion independence in patients with myelodysplastic syndromes (MDS).

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