What are the effects of fezolinetant on the endometrium?

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In a pooled analysis of the 52-week Phase 3 trials SKYLIGHT 1, 2 and 4, change in endometrial thickness from baseline was similar across fezolinetant and placebo treatment groups, and the rates of endometrial hyperplasia and malignancy were within FDA pre-specified limits

  • Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsies.1

  • Five cases (1.4%) of disordered proliferative endometrium were reported in women receiving fezolinetant 45 mg, six (1.7%) in women receiving fezolinetant 30 mg, and four (2.0%) in women receiving placebo across the three clinical trials.1
  • The frequency of endometrial hyperplasia or endometrial malignancy for postbaseline endometrial biopsies in fezolinetant-treated participants met the FDA prespecified limits of ≤ 1% with an upper limit of the one-sided 95% confidence interval (CI) rate being ≤ 4% for endometrial safety.1
    • One participant (0.3%) in the fezolinetant 30 mg group and two participants (0.6%) in the fezolinetant 45 mg group had a final biopsy diagnosis of endometrial hyperplasia (upper limit of the one-sided 95% CI of the rate was 1.3% and 1.8%, respectively).
    • One participant (0.3%) in the fezolinetant 30 mg group had a final biopsy diagnosis of endometrial malignancy (upper limit of the one-sided 95% CI of the rate was 1.3%). No participants in the fezolinetant 45 mg group had a final biopsy diagnosis of endometrial malignancy.

  1. Kagan R, Cano A, Nappi RE, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2024; Available at: https://doi.org/10.1007/s12325-024-03073-8.

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