Have alternative fezolinetant doses or regimens been studied for vasomotor symptoms?

Published

Prescribing Information including BOXED WARNING

The recommended dose of fezolinetant is 45 mg orally once daily. Fezolinetant was studied at doses of 30 mg and 45 mg once daily in Phase 3 studies, and at total daily doses ranging from 15 mg to 180 mg in Phase 2 studies

Fezolinetant was studied at doses of:

30 mg and 45 mg once daily in Phase 3 studies^1–6
15 mg, 30 mg, 60 mg, and 90 mg twice daily and 15 mg, 30 mg, 60 mg, and 120 mg once daily in Phase 2 studies in women with menopausal vasomotor symptoms^7–10
60 mg and 180 mg once daily in Phase 2 studies in women with polycystic ovary syndrome¹¹ and uterine fibroids¹²

Dosing regimens outside of the prescribing information are not recommended and would be up to the clinical discretion of the prescriber.

Additional details of the Phase 2 and 3 clinical trials are available on request.

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. Endocrinol. Metab. 2023;108(8):1981-1997. Available at: https://doi.org/10.1210/clinem/dgad058.
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. Available at: https://doi.org/10.1016/s0140-6736(23)00085-5.
Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause. Obstet. Gynecol. 2023;141(4):737-747. Available at: https://doi.org/10.1097/aog.0000000000005114.
Schaudig K, Wang X, Bouchard C, et al. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial. BMJ. 2024;387(387):e079525. Available at: https://doi.org/10.1136/bmj-2024-079525.
Ruan X, Bai W, Ren M, et al. Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I). J. Int. Méd. Res. 2024;52(5):1-19. Available at: https://doi.org/10.1177/03000605241247684.
Yu Q, Ming F, Ma J, et al. Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial. J. Int. Méd. Res. 2024;52(5):1-16. Available at: https://doi.org/10.1177/03000605241246624.
Depypere H, Timmerman D, Donders G, et al. Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial. J. Clin. Endocrinol. Metab. 2019;104(12):5893-5905. Available at: https://doi.org/10.1210/jc.2019-00677.
Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause (N. York, Ny). 2020;27(4):382-392. Available at: https://doi.org/10.1097/GME.0000000000001510.
Santoro N, Waldbaum A, Lederman S, et al. Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA). Menopause (N. York, Ny). 2020;27(12):1350-1356. Available at: https://doi.org/10.1097/GME.0000000000001621.
Takamatsu K, Miki T, Miyazaki K, et al. Phase II study of fezolinetant for treatment of vasomotor symptoms associated with menopause in Japan. Climacteric. 2024;27(4):389-397. Available at: https://doi.org/10.1080/13697137.2024.2356854.
Fraser GL, Obermayer-Pietsch B, Laven J, et al. Randomized Controlled Trial of Neurokinin 3 Receptor Antagonist Fezolinetant for Treatment of Polycystic Ovary Syndrome. J. Clin. Endocrinol. Metab. 2021;106(9):e3519-e3532. Available at: https://doi.org/10.1210/clinem/dgab320.
Data on file.