• Holger Schmid.
• University of Munich, Department of Internal Medicine, Munich, D-80336, Germany. holger.schmid@lrz.uni-muenchen.de
• Expert Opin Pharmacother. 2013 May 1;14(7):937-48.

IntroductionErythropoiesis-stimulating agents (ESAs) are the mainstay of treatment in anemic chronic kidney disease (CKD) patients. A tailored ESA therapy should combine maximal efficacy and safety with greatest convenience in dosing. Peginesatide, recently approved in the US for once-monthly dosing in adult patients on dialysis, is a promising novel PEGylated erythropoietin-mimetic peptide for the treatment of renal disease-induced anemia.Areas CoveredPublished animal and human studies that evaluated the pharmacodynamics, pharmacokinetics, clinical efficacy and safety of peginesatide were critically analyzed.Expert OpinionPeginesatide has a well-studied pharmacological and immunological profile, and latest published data favor the use of peginesatide in place of epoetin in dialysis patients. A more detailed evaluation of its safety profile particularly in trials with CKD patients not requiring dialysis is urgently needed, as peginesatide could be a perfect treatment solution for these patients. In addition, clinical long-term data and results from supplemental studies, e.g., with the PEGylated continuous erythropoietin receptor activator as comparator, should briefly follow. The fate of peginesatide on the highly competitive ESA market is currently not predictable and depends on safety and efficacy results of upcoming trials as well as finally on market and price policy.

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