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Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT.
Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Johnson KA, et al. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058. J Clin Endocrinol Metab. 2023. PMID: 36734148 Free PMC article. Clinical Trial.
METHODS: In 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, fezoline …
METHODS: In this double-blind, placebo-controlled, 12-week phase 3 trial with a 40-week active treatment extension (NCT04003142; SKYLIGHT 2) …
Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.
Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, Thurston RC, English M, Franklin C, Lee M, Neal-Perry G. Lederman S, et al. Lancet. 2023 Apr 1;401(10382):1091-1102. doi: 10.1016/S0140-6736(23)00085-5. Epub 2023 Mar 13. Lancet. 2023. PMID: 36924778 Clinical Trial.
FINDINGS: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant 30 mg, and 176 to fezolinetant 45 mg (175 in the placebo group, 174 in the fezolinetant 30 mg group, and 173 in the fezol …
FINDINGS: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant …
Fezolinetant in the treatment of vasomotor symptoms associated with menopause.
Depypere H, Lademacher C, Siddiqui E, Fraser GL. Depypere H, et al. Expert Opin Investig Drugs. 2021 Jul;30(7):681-694. doi: 10.1080/13543784.2021.1893305. Epub 2021 Jul 12. Expert Opin Investig Drugs. 2021. PMID: 33724119 Review.
There is therefore a need for safe, effective non-hormonal therapy for relief of menopausal vasomotor symptoms (VMS).Areas covered: This narrative review summarizes the dataset accrued for fezolinetant, a neurokinin-3 receptor (NK3R) antagonist in clinical development for …
There is therefore a need for safe, effective non-hormonal therapy for relief of menopausal vasomotor symptoms (VMS).Areas covered: This nar …
Fezolinetant: First Approval.
Lee A. Lee A. Drugs. 2023 Aug;83(12):1137-1141. doi: 10.1007/s40265-023-01917-1. Drugs. 2023. PMID: 37462862 Review.
Fezolinetant (VEOZAH) is an oral, small molecule, neurokinin 3 receptor (NK3R) antagonist, which is being developed by Astellas Pharma Inc. for the treatment of moderate to severe vasomotor symptoms (VMS) or hot flashes due to menopause. ...This article summarizes the mile …
Fezolinetant (VEOZAH) is an oral, small molecule, neurokinin 3 receptor (NK3R) antagonist, which is being developed by Astellas Pharm …
Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial.
Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, English M, Franklin C, Valluri U, Ottery FD. Neal-Perry G, et al. Obstet Gynecol. 2023 Apr 1;141(4):737-747. doi: 10.1097/AOG.0000000000005114. Epub 2023 Mar 9. Obstet Gynecol. 2023. PMID: 36897180 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate the safety, tolerability, and effect of fezolinetant on endometrial health over 52 weeks. METHODS: We conducted a phase 3, randomized, double-blind, 52-week safety study (SKYLIGHT 4 [Study to Find Out How Safe Long-term Treatment With Fezolinetant …
OBJECTIVE: To evaluate the safety, tolerability, and effect of fezolinetant on endometrial health over 52 weeks. METHODS: We conducte …
Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms.
Onge ES, Phillips B, Miller L. Onge ES, et al. J Pharm Technol. 2023 Dec;39(6):291-297. doi: 10.1177/87551225231198700. Epub 2023 Sep 16. J Pharm Technol. 2023. PMID: 37974591 Review.
Objective: To review the safety, efficacy, and tolerability of fezolinetant for the treatment of vasomotor symptoms associated with menopause. ...Clinical trials have demonstrated fezolinetant is superior to placebo in decreasing the frequency and severity of vasomo …
Objective: To review the safety, efficacy, and tolerability of fezolinetant for the treatment of vasomotor symptoms associated with m …
Fezolinetant.
Beninger P. Beninger P. Clin Ther. 2023 Aug;45(8):802-803. doi: 10.1016/j.clinthera.2023.06.019. Epub 2023 Jul 11. Clin Ther. 2023. PMID: 37442655 No abstract available.
Fezolinetant.
[No authors listed] [No authors listed] Am J Health Syst Pharm. 2023 Aug 18;80(17):1113-1114. doi: 10.1093/ajhp/zxad125. Am J Health Syst Pharm. 2023. PMID: 37382493 No abstract available.
Randomized Controlled Trial of Neurokinin 3 Receptor Antagonist Fezolinetant for Treatment of Polycystic Ovary Syndrome.
Fraser GL, Obermayer-Pietsch B, Laven J, Griesinger G, Pintiaux A, Timmerman D, Fauser BCJM, Lademacher C, Combalbert J, Hoveyda HR, Ramael S. Fraser GL, et al. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3519-e3532. doi: 10.1210/clinem/dgab320. J Clin Endocrinol Metab. 2021. PMID: 34000049 Free PMC article. Clinical Trial.
Women with PCOS participated in the study. Interventions included fezolinetant 60 or 180 mg/day or placebo for 12 weeks. The primary efficacy end point was change in total testosterone. ...Circulating levels of progesterone and estradiol did not change significantly vs pla …
Women with PCOS participated in the study. Interventions included fezolinetant 60 or 180 mg/day or placebo for 12 weeks. The primary …
Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).
Santoro N, Waldbaum A, Lederman S, Kroll R, Fraser GL, Lademacher C, Skillern L, Young J, Ramael S. Santoro N, et al. Menopause. 2020 Dec;27(12):1350-1356. doi: 10.1097/GME.0000000000001621. Menopause. 2020. PMID: 32769757 Free PMC article. Clinical Trial.
Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: -2.2; fezolinetant: range, -2.5 to -3.8) and 12 (placebo: -2.9; fezolinetant: range, -3.3 to -4.3) exceeded the MID (1.76). Greene Climacteric Scale-VMS domain scores improved for most …
Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: -2.2; fezolinetant: range, -2.5 to -3.8) and 12 (plac …
60 results