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.

  • OPTION-VMS is an ongoing, Phase 4, longitudinal, multicenter, observational study of women prescribed non-hormonal therapy for VMS. Two preliminary analyses of the OPTION-VMS study were presented during The Menopause Society 2025 in Orlando, Florida.
  • In one of the preliminary analyses focused on assessing changes from baseline to week 12, it was reported that fezolinetant showed statistically significant improvements in MENQOL domains (VMS, sexual, psychosocial, and physical), PROMIS SD SF 8b total scores, and actigraphy endpoints, sleep onset (WASO), sleep efficiency, and sleep latency at week 12.2  The incidence of fezolinetant-related TEAEs was low, and no new safety signals were identified.
  • The other was a preliminary analysis of non-HT effect on work productivity measured with the 6-item patient-reported outcome, WPAI-VMS.3  It was reported that fezolinetant showed statistically significant within-group improvements (p < 0.001) from baseline in WPAI-VMS domains (overall work productivity loss, activity impairment, and presenteeism) at weeks 4, 8 and 12. Statistically significant within-group improvements from baseline were also seen for SSRIs/SNRIs (p < 0.001) and other non-HT treatments (p < 0.05).

  1. Data on file.

  2. Neal-Perry G, Lederman S, Mancuso S, et al. OPTION-VMS: Preliminary Analysis of a Phase IV Observational, Real-World Study of Non-hormonal Pharmacotherapies for Bothersome Menopause-Associated Vasomotor Symptoms [poster]. Orlando, FL, USA. The Menopause Society (TMS) 2025 Annual Meeting; 2025.

  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]. Orlando, FL, USA. The Menopause Society (TMS) 2025 Annual Meeting; 2025.

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