Does fezolinetant treat hot flashes (VMS) induced by medication?

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Currently, no information is available on the safety and efficacy of fezolinetant in individuals suffering from treatment-induced vasomotor symptoms (VMS).

  • The Phase 3 HIGHLIGHT 1 trial (NCT06440967) is ongoing to investigate the safety and efficacy of fezolinetant 45 mg for the treatment of moderate to severe VMS in women with Stage 0 to 3 hormone receptor positive (either HER-2+ or HER-2-) breast cancer who are receiving adjuvant endocrine therapy (tamoxifen 20 mg or daily aromatase inhibitors) with or without gonadotrophin releasing hormone (GnRH) agonists/antagonists for a minimum of four months and not receiving chemotherapy.1
  • OPTION-VMS (NCT06049797) is an ongoing real-world Phase 4 study to assess the change in VMS bother in women with a confirmed diagnosis of VMS who are initiating nonhormonal therapy, including fezolinetant.2,3 Participants with non-metastatic (Stage 0 to 3) breast cancer who have been prescribed adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitors with or without GnRH analogues) and have maintained a stable treatment regimen for ≥ 3 months can be included.
  • There are currently no studies on the effect of fezolinetant on treatment-induced VMS in men.

  1. Bouchard C, Miyazaki K, Tang CH, et al. Trial in Progress: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the efficacy and safety of fezolinetant for treatment of moderate-to-severe vasomotor symptoms (hot flashes) in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy [poster]. The International Menopause Society (IMS) World Congress. Melbourne, Australia. Poster #P055. 2024.

  2. Pozlep B. OPTION-VMS: First real-world fezolinetant effectiveness and safety data, including objective sleep data, in a phase 4 observational study of non-hormonal treatments for bothersome menopause-associated vasomotor symptoms [oral slide presentation]. Congress of Slovenian Gynaecologists and Obstetricians (SCG). Ljubljana, Slovenia. 2026.

  3. Maki PM, Mancuso S, Helbing M, et al. Preliminary Analysis of Work Productivity Outcomes in OPTION-VMS: A Phase IV Observational, Real-World Study of Non-hormonal Treatment for Bothersome Menopause-Associated Vasomotor Symptoms [poster]. The Menopause Society (TMS) 2025 Annual Meeting. Orlando, FL, USA. 2025.

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