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Can fezolinetant be used in women who are not postmenopausal?

Published:

Fezolinetant is not indicated for use in pre- and perimenopause as there are insufficient data to support clinical use in this population

  • Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause, based on data from the Phase 3 SKYLIGHT studies which only enrolled women aged ≥ 40 and ≤ 65 years who were confirmed as postmenopausal.1–3

  • Premenopausal women with a regular ovulatory menstrual cycle have been included in Phase 1 studies to assess single and multiple dose safety and tolerability in healthy Japanese individuals4, and safety, pharmacokinetics, and pharmacokinetics on gonadotropins and sex hormones after single- and multiple-doses.5
  • Some perimenopausal women were enrolled in the Phase 2 STARLIGHT study to select the optimal dose(s) in Japanese women suffering from VMS associated with menopause.6

  1. 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.

  2. 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.

  3. 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.

  4. Data on file.

  5. 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.

  6. 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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