Is there a known drug-drug interaction (DDI) between fezolinetant and testosterone?

Published

Astellas has not conducted clinical studies to evaluate a DDI between fezolinetant and testosterone and there was no previous and / or concomitant use of testosterone reported in key Phase 3 studies of fezolinetant. According to several DDI databases, there is no known interaction between fezolinetant and testosterone.

  • Fezolinetant is primarily metabolized by CYP1A2, and to a lesser extent by CYP2C9 and CYP2C19.1
  • Participants were excluded from the fezolinetant Phase 3 clinical trials (SKYLIGHT 1, 2, and 4) if they were receiving strong or moderate CYP1A2 inhibitors, HRT, hormonal contraceptives, or any treatment for VMS (prescription, over the counter, or herbal).2–4
  • According to Drugs, Lexicomp and DynaMed drug interaction results, there is no known risk of DDI between fezolinetant and testosterone.5–7

  1. Data on File.

  2. 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.

  3. 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.

  4. 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.

  5. Electronic Citation. Drug Interactions Checker. Available at: https://www.drugs.com/.

  6. Electronic Citation. DynaMed. Available at: https://www.dynamed.com/.

  7. Electronic Citation. Lexidrug Drug Interactions Checker. Available at: http://online.lexi.com/.

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