INTRODUCTION: Erythropoiesis-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 COVERED: Published animal and human studies that evaluated the 
pharmacodynamics, pharmacokinetics, clinical efficacy and safety of peginesatide 
were critically analyzed.
EXPERT OPINION: Peginesatide 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.