Drug name (generic) | Peginesatide |
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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) |