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. Author manuscript; available in PMC: 2017 Oct 1.
Published in final edited form as: Expert Opin Drug Saf. 2016 Aug 23;15(10):1421–1426. doi: 10.1080/14740338.2016.1218467
Drug name (generic) Peginesatide
Phase (for indication under discussion) Voluntary withdrawal by the manufacturer from the United States market in 2013
Indication Anemia treatment among adult CKD patients receiving hemodialysis
Pharmacology description/mechanism of action Peginesatide mimics the structure of erythropoietin and stimulates erythropoiesis in red blood cell precursors in a manner similar to recombinant ESAs
Chemical structure Peginesatide is a synthetic dimeric peptide, attached to polyethylene glycol (“ pegylated”) by a unique space linker and composed of two 21 amino acid chains. The peptide structure shares no homology with first and second generation ESAs, erythropoietin and darbepoetin.
Pivotal trials *A phase 2 study investigating whether peginesatide can stimulate erythropoiesis in CKD patients with PRCA due to antierythropoietin antibodies (5)
*EMERALD 1 and 2 phase 3 studies evaluated the efficacy and safety of peginesatide in previously ESA-treated patients with anemia due to CKD on dialysis (9)
*PEARL 1 and 2 phase 3 studies evaluated the efficacy and safety of peginesatide in patients with anemia due to CKD and not on dialysis or ESAs (10)