HematologyFDA Approved

Peginesatide (Omontys)

Intravenous, Subcutaneous injection

Overview

Peginesatide is a synthetic pegylated peptide-based erythropoiesis-stimulating agent (ESA) consisting of two 21-amino acid chains linked to polyethylene glycol. Unlike recombinant erythropoietin, it contains no erythropoietin sequence homology yet activates the erythropoietin receptor to stimulate red blood cell production.

Mechanism of Action

The pegylation confers a prolonged half-life, enabling once-monthly dosing in dialysis-dependent chronic kidney disease..

Research Summary & Key Findings

The FDA approved peginesatide in March 2012 for treatment of anemia in adult dialysis-dependent chronic kidney disease patients, based on two Phase 3 trials (EMERALD 1 and 2) demonstrating non-inferiority to darbepoetin alfa. The manufacturer voluntarily withdrew peginesatide from the U.S. market in February 2013 following reports of serious hypersensitivity reactions including anaphylaxis and deaths.

Clinical Status

FDA Approved

Peginesatide (Omontys) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

IntravenousSubcutaneous injection

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.