Elinzanetant (NT-814): a novel, non-hormonal dual NK-1,3 receptor antagonist for the treatment of vasomotor symptoms - key findings from the Phase 2 SWITCH-1 study

Abstract

Introduction: Vasomotor symptoms (VMS) are common, with long lasting and debilitating effects on quality of life (QoL) during and after the menopause transition. There is an unmet need for safe and effective non-hormonal treatments for these symptoms. Hypothalamic KNDy neurons are central to the thermoregulatory dysfunction associated with VMS. They express Substance P (neurokinin [NK]-1R ligand) and NKB (NK-3R ligand) and are hypertrophied and hyperactive in oestrogen-deprived post-menopausal women. Elinzanetant is a dual NK-1 and NK-3 receptor antagonist. A prior Phase 2a study showed rapid and marked improvements in VMS in post-menopausal women and this study (SWITCH-1) was a Phase 2b double-blind, placebo-controlled, dose-finding trial which evaluated the optimal dose of elinzanetant for Phase 3 studies.