PEGINESATIDE ACETATE

US Previously Marketed

First approved in 2012

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf
Curator's Comment: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/22971699; http://www.ncbi.nlm.nih.gov/pubmed/23318685

Peginesatide (trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Erythropoietin receptor 2 Target ID: P19235 Gene ID: 2057.0 Gene Symbol: EPOR Target Organism: Homo sapiens (Human) Sources: http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/09/WC500148933.pdf	Activator 1430

Conditions

Condition	Modality	Targets	Highest Phase	Product
Anemia 68 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf	Primary		Approved 8429	OMONTYS Approved Use Indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Launch Date 2012

PubMed

Title	Date	PubMed
Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile.	2009 Nov	19710368
Detection of peginesatide in equine serum using liquid chromatography-tandem mass spectrometry for doping control purposes.	2012	22971699
Lessons learned from peginesatide in the treatment of anemia associated with chronic kidney disease in patients on dialysis.	2013	24348017
Managing dialysis patients who develop anemia caused by chronic kidney disease: focus on peginesatide.	2013	24023516
Peginesatide for anemia in chronic kidney disease.	2013 Apr 18	23594011
Peginesatide for anemia in chronic kidney disease.	2013 Apr 18	23594010
Peginesatide as a new approach for treating anemia of CKD patient: is it like a falling star?	2013 Jul	23675762
[New treatments of anemia in chronic renal failure].	2014 Jul 7	24467877
Relative safety of peginesatide and epoetin alfa.	2014 Oct	24905967
Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis.	2015 Jul-Aug	24584613

Patents

Sample Use Guides

In Vivo Use Guide

Initiate OMONTYS treatment when the hemoglobin level is less than 10 g/dL. The recommended starting dose for the treatment of anemia in patients who are not currently treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly.

Route of Administration: Intravenous

In Vitro Use Guide

Unknown

Substance Class	Protein Created by `admin` on `Fri Dec 15 23:04:29 GMT 2023` Edited by `admin` on `Fri Dec 15 23:04:29 GMT 2023`
Protein Sub Type
Sequence Type	COMPLETE
Record UNII	44STI720CW
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

PEGINESATIDE ACETATE

Official Name

English

AF37702 ACETATE

Code

English

PEGINESATIDE ACETATE [ORANGE BOOK]

Common Name

English

HEMATIDE ACETATE

Brand Name

English

Peginesatide acetate [WHO-DD]

Common Name

English

PEGINESATIDE ACETATE [USAN]

Common Name

English

AF-37702 ACETATE

Code

English

AF 37702 ACETATE

Code

English

Code System Code Type Description

USAN

ZZ-99