AIM To evaluate clinical efficacy and safety of AOBO-001 oral capsule for the treatment of Urinary incontinence (UI).METHODS The Phase Ⅱ a clinical trial was a randomized, double-blind, placebo-controlled, parallel-group study in adult patients with symptoms related to OAB, and was conducted at five centers in the United States.Sixty-six subjects who successfully completed a 2-week placebo run-in period were randomized to three treatment groups for 12 weeks in a 1: 1:1 ratio of AOBO-001 1.6 g b.i.d.or 3.2 g b.i.d or matching placebo.The primary endpoints for the efficacy assessment were "Change in Average Number of Micturitions per 24 Hours" and "Change in Average Number of Urge Urinary Incontinence Episodes per 24 Hours" based upon the FDA approval standards for the "overactive bladder" treatments such as Fesoterodine Fumarate (Toviaz).RESULTS Average age was 54.5 years (range : 23 to 83 years) and 80% were women.Change in micturitions per 24 h : the average reductions from baseline micturitions were 1.8 for the both active treatment groups, compared with-1.2 for placebo.Change in urge incontinence per 24 h: the average reductions in urge incontinence were-2.09 and-3.39 for 1.6 g and 3.2 g (BID) doses, compared with-1.56 for placebo among subjects with baseline number of micturitions > 8 per 24 h and baseline number of urge urinary incontinence episodes > 3 per 24 h.The results of our analyses are similar to the reported treatment effects observed in Toviaz pivotal studies.CONCLUSION The observed decrease in disease activity scores was clinical significant and relevant in AOBO-001 active treatments.Further confirmation is indicated in a larger efficacy study.