Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, last week initiated a late-stage trial in Japan for fezolinetant, a neurokinin B (NKB) blocker, as a potential treatment for vasomotor symptoms (VMS) associated with menopause in women. This placebo-controlled study aims to evaluate the efficacy and safety of the oral, once-daily, nonhormonal compound over a 12-week period, with the primary endpoint being the mean change in the frequency of VMS from baseline.
Parallel to this, Astellas is already engaged in another Phase III study that assesses the candidate’s safety and tolerability over a longer duration of 52 weeks. The primary endpoint for this study is focused on the frequency and severity of adverse events.- Flcube.com