Trial reportThe Journal of clinical endocrinology and metabolism2023
Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT.
Trial report in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 59 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)
Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.
A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)
Who cites it
59 citing papers in PubMed, 4 syntheses or guidelines pooled it, 175 citations in OpenAlex.
- Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies.Advances in therapy · 2025Pooled it
- Fezolinetant's efficacy and safety in treatment of vasomotor symptoms in postmenopausal women: a meta-analysis and GRADE evaluation of randomized controlled trials.European journal of medical research · 2025Pooled it
- Brazilian Guideline on Menopausal Cardiovascular Health - 2024.Arquivos brasileiros de cardiologia · 2024Guideline
- Pooled it
- Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial.Menopause (New York, N.Y.) · 2026Trial
- Pharmacokinetics, Tolerability, and Biomarker Profile of the Neurokinin 3 Receptor Antagonist Fezolinetant in Healthy Japanese Individuals: A 2-Part, Randomized, Phase 1 Study.Clinical pharmacology in drug development · 2025Trial
- Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial.BMJ (Clinical research ed.) · 2024Trial
- Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data.Advances in therapy · 2024Trial
- Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause.Advances in therapy · 2024Trial
- Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I).The Journal of international medical research · 2024Trial
- Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial.The Journal of international medical research · 2024Trial
- Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial.Scientific reports · 2023Trial
- Flushing: Neuroendocrine Mechanisms and a Structured Diagnostic Approach.Clinical endocrinology · 2026Review
- Hormone therapy (HT) in women with premature ovarian insufficiency or early menopause: Time to think of a new paradigm for healthy aging. A joint FIGO and IMS position paper.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Microvascular endothelial function is blunted in postmenopausal females with frequent hot flushes.Experimental physiology · 2026Article
- Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant.Breast (Edinburgh, Scotland) · 2026Review
- Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms Associated with Menopause: Insights from the WARMER Study.The patient · 2026Article
- Neurokinin receptor antagonists for vasomotor symptoms: from KNDy neurons to clinical translation.Nature reviews. Endocrinology · 2026Review
- TACR3 variant confers resilience to aging and Alzheimer's disease.medRxiv : the preprint server for health sciences · 2026Article
- Potential risk of neoplasms with fezolinetant: clinical evidence, mechanisms, and post-marketing implications.Journal of the Endocrine Society · 2026Review
Corrections and comments
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Authors and funding
12 authors at 9 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextVasomotor symptoms (VMS) are common, bothersome, and can persist for years before and after menopause.
objectiveWe aimed to assess efficacy/safety of fezolinetant for treatment of moderate to severe VMS associated with menopause.
methodsIn this double-blind, placebo-controlled, 12-week phase 3 trial with a 40-week active treatment extension (NCT04003142; SKYLIGHT 2), women aged 40 to 65 years with minimum average 7 moderate to severe VMS/day were randomized to 12 weeks of once-daily placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Completers were rerandomized to fezolinetant 30/45 mg for 40 additional weeks. Coprimary efficacy endpoints were mean daily change from baseline to week 4 (W4) and W12 in VMS frequency and severity. Safety was also assessed.
resultsBoth fezolinetant doses statistically significantly reduced VMS frequency/severity at W4 and W12 vs placebo. For VMS frequency, W4 least squares mean (SE) reduction vs placebo: fezolinetant 30 mg, -1.82 (0.46; P < .001); 45 mg, -2.55 (0.46; P < .001); W12: 30 mg, -1.86 (0.55; P < .001); 45 mg, -2.53 (0.55; P < .001). For VMS severity, W4: 30 mg, -0.15 (0.06; P < .05); 45 mg, -0.29 (0.06; P < .001); W12: 30 mg, -0.16 (0.08; P < .05); 45 mg, -0.29 (0.08; P < .001). Improvement in VMS frequency and severity was observed by W1 and maintained through W52. Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo, respectively.
conclusionDaily fezolinetant 30 and 45 mg were efficacious and well tolerated for treating moderate to severe VMS associated with menopause.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.