Fezolinetant is not indicated for use in pre- and perimenopause as there are insufficient data to support clinical use in this population
Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401(10382):1091-1102. https://dx.doi.org/10.1016/s0140-6736(23)00085-5.
Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocr Metab. 2023;108(8):1981-1997. https://dx.doi.org/10.1210/clinem/dgad058.
Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023;141(4):737-747. https://dx.doi.org/10.1097/aog.0000000000005114.
Data on file.
Fraser GL, Ramael S, Hoveyda HR, Gheyle L, Combalbert J. The NK3 Receptor Antagonist ESN364 Suppresses Sex Hormones in Men and Women. J Clin Endocrinol Metab. 2016;101(2):417-426. https://dx.doi.org/10.1210/jc.2015-3621.
Takamatsu K, Miki T, Miyazaki K, Hashimoto A, He W, Wang X. Phase II study of fezolinetant for treatment of vasomotor symptoms associated with menopause in Japan. Climacteric. 2024. https://dx.doi.org/10.1080/13697137.2024.2356854.
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