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Erythropoietin

Generic Name
Erythropoietin
Brand Names
Procrit, Eprex, Epprex, Epoetin Alfa Hexal, Silapo, Biopoin, Abseamed, Eporatio, NeoRecormon, Epogen, Retacrit
Drug Type
Biotech
CAS Number
11096-26-7
Unique Ingredient Identifier
64FS3BFH5W

Overview

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Background

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Indication

用于肾功能不全合并的贫血,艾滋病本身或因治疗引起的贫血,恶性肿瘤伴发的贫血及风湿性贫血等。另外,为择期手术储存自体血而反复采血的患者,同时应用本品可预防发生贫血。

Associated Conditions

  • Anemia
  • Blood Loss During Surgery
  • Anemia caused by Zidovudine

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/17
Phase 3
Recruiting
2025/05/21
N/A
Not yet recruiting
2025/04/09
Phase 1
Not yet recruiting
2025/03/03
Phase 2
Not yet recruiting
2024/12/06
Phase 3
Completed
2024/09/10
Early Phase 1
Not yet recruiting
2024/08/07
Phase 2
Recruiting
Federal University of São Paulo
2024/07/22
Phase 4
Recruiting
2023/12/21
Phase 4
Completed
2023/11/18
Phase 3
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-2523
INTRAVENOUS, SUBCUTANEOUS
10000 [iU] in 1 mL
1/17/2013
Janssen Products, LP
59676-304
INTRAVENOUS, SUBCUTANEOUS
4000 [iU] in 1 mL
11/1/2023
Janssen Products, LP
59676-303
INTRAVENOUS, SUBCUTANEOUS
3000 [iU] in 1 mL
11/1/2023
Janssen Products, LP
59676-312
INTRAVENOUS, SUBCUTANEOUS
10000 [iU] in 1 mL
11/1/2023
Physicians Total Care, Inc.
54868-5802
INTRAVENOUS, SUBCUTANEOUS
40000 [iU] in 1 mL
1/17/2013
Janssen Products, LP
59676-340
INTRAVENOUS, SUBCUTANEOUS
40000 [iU] in 1 mL
11/1/2023
Janssen Products, LP
59676-320
INTRAVENOUS, SUBCUTANEOUS
20000 [iU] in 1 mL
11/1/2023
Janssen Products, LP
59676-310
INTRAVENOUS, SUBCUTANEOUS
10000 [iU] in 1 mL
11/1/2023
Physicians Total Care, Inc.
54868-5673
INTRAVENOUS, SUBCUTANEOUS
20000 [iU] in 1 mL
1/17/2013
Janssen Products, LP
59676-302
INTRAVENOUS, SUBCUTANEOUS
2000 [iU] in 1 mL
11/1/2023

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Human Erythropoietin for Injection
国药准字S19991023
生物制品
冻干粉针剂
8/5/2020
Human Erythropoietin for Injection
国药准字S19980080
生物制品
冻干粉针剂
5/12/2020
Human Erythropoietin for Injection
国药准字S19991024
生物制品
冻干粉针剂
5/12/2020
Human Erythropoietin for Injection
国药准字S20217021
生物制品
冻干粉针剂
8/30/2021
Human Erythropoietin for Injection
国药准字S19991025
生物制品
冻干粉针剂
7/2/2020
Human Erythropoietin Injection
国药准字S20113005
生物制品
注射液
7/13/2020
Human Erythropoietin Injection
国药准字S20230053
生物制品
注射剂
9/28/2023
Human Erythropoietin Injection
国药准字S20010018
生物制品
注射剂
4/26/2024
Human Erythropoietin Injection
国药准字S20000027
生物制品
注射剂
4/30/2020
Human Erythropoietin Injection
国药准字S19980074
生物制品
注射剂
7/13/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
RECORMON P/FILLED SYRINGE 5000IU/0.3ML
N/A
N/A
N/A
12/11/2000
RECORMON P/FILLED SYRINGE 4000IU/0.3ML
N/A
N/A
N/A
1/11/2002
RECORMON P/FILLED SYRINGE 2000IU/0.3ML
N/A
N/A
N/A
12/11/2000
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