MedPath

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

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

Title
Posted
Study ID
Phase
Status
Sponsor
2022/05/27
Phase 3
Recruiting
2022/05/04
Early Phase 1
Completed
2022/04/13
Phase 4
Active, not recruiting
2022/03/29
Phase 4
Active, not recruiting
United States Army Research Institute of Environmental Medicine
2022/01/06
Phase 1
Recruiting
2021/12/22
Phase 2
Completed
2021/10/15
Phase 3
Active, not recruiting
University Hospital, Angers
2021/07/13
Phase 4
Completed
Rufaida Mazahir
2021/06/02
Phase 3
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
2021/05/13
Phase 2
Completed

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

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

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Human Erythropoietin Injection
国药准字S20053103
生物制品
注射剂
5/15/2020
Human Erythropoietin Injection
国药准字S20133012
生物制品
注射剂
4/30/2020
Human Erythropoietin Injection
国药准字S20133003
生物制品
注射剂
1/13/2020
Human Erythropoietin Injection
国药准字S20103002
生物制品
注射剂
1/13/2020
Human Erythropoietin Injection
国药准字S20020060
生物制品
注射剂(注射液)
6/23/2021
Human Erythropoietin Injection
国药准字S20053105
生物制品
注射剂
5/15/2020
Human Erythropoietin Injection
国药准字S19980073
生物制品
注射剂
7/13/2020
Human Erythropoietin Injection
国药准字S20030021
生物制品
注射剂
2/22/2020
Human Erythropoietin Injection
国药准字S20153009
生物制品
注射剂
6/11/2020
Human Erythropoietin Injection
国药准字S20010041
生物制品
注射剂
4/26/2024

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath