Recent advances in the understanding of the physiopathology of OAB have driven a huge amount of basic and clinical research into novel pharmacological compounds. Among potential novel peripherally acting drugs, β3-adrenoceptor (AR) agonists appear very promising [Sacco et al. 2008]. Mirabegron (also known as YM178) is a novel, once-daily orally active, first-in-class, potent β 3-AR agonist [Takasu et al. 2007]. Regulatory applications for mirabegron are under review in several countries. In July 2011, mirabegron was granted marketing approval in Japan and was launched in September 2011. In June 2012 FDA also approved mirabegron (Myrbetriq, Astellas Pharma US, Inc.). Thereafter we reviewed clinical data on the safety and efficacy of mirabegron by searching English language full papers and abstracts in MEDLINE, ClinicalTrials.gov, controlled-trials.