VMS, commonly referred to as hot flashes (HF, also called “flushes”), are one of the mostcommon, bothersome and distressing symptoms felt by women during the menopausetransition, and the leading cause for seeking medical attention during this particular phase of awoman’s life (Pachman et al. 2010). Effective treatment options are mostly limited tohormone therapy, which despite being effective is associated with safety concerns such asincreased risk of hormone-dependent cancers and cardiovascular adverse effects, includingthrombotic risk (BIJUVA® Prescribing Information 2018, PREMARIN® Prescribinginformation 2017). A low dose of the anti-depressant paroxetine is approved in US fortreatment of VMS but has limited efficacy and a range of safety and tolerability concerns thatprevent its widespread usage (BRISDELLE® Prescribing Information 2017).Since hormone treatment is not an option for many women suffering from moderate andsevere VMS, either because of contraindications or personal preferences, there is a strongmedical need for an effective non-hormonal treatment option with improved benefit / riskbalance.Elinzanetant (formerly NT-8141) is a dual neurokinin (NK)-1,3 receptor antagonist. Dataindicate that HF may be treated by targeting the neuroendocrine factors that trigger the VMS(Rance et al. 2013).