Key finding
In SKYLIGHT 1, 527 women with moderate to severe hot flushes took fezolinetant 30 mg, 45 mg or placebo daily. By week 12, both doses reduced hot flushes by about 2.4 to 2.6 more episodes a day than placebo and reduced their severity, with benefit from the first week. The effect was maintained to week 52 in an extension without a placebo group. Sleep disturbance scores did not improve significantly.
Fezolinetant gives an option for women who cannot or prefer not to use hormone therapy, where it is available. Rare but serious liver injury has been reported (US boxed warning, December 2024): check liver blood tests before starting and during treatment, as the product labelling sets out, and stop at once if signs of liver injury appear.
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.
Read the original paperSummarised by the Draxer Clinical Advisory Department for health professionals. It supports, and does not replace, clinical judgement.