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Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan | ||
By: PR Newswire Association LLC. - 04 Mar 2024 | Back to overview list |
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TOKYO, March 3, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women. In Japan, two Phase 3 clinical studies are underway. STARLIGHT 2 is evaluating the efficacy and safety of fezolinetant once-daily through 12 weeks. STARLIGHT 3 is evaluating the safety and tolerability of fezolinetant once-daily through 52 weeks. Marci English, Vice President, Head of BioPharma Development, Astellas Dosing for the STARLIGHT Phase 3 clinical studies was determined based on available global data, including the STARLIGHT Phase 2b study (NCT05034042) that enrolled 147 patients and completed in 2022. Primary results of STARLIGHT Phase 2b were presented at the Annual Meeting of the Japan Society for Menopause and Women's Health on Dec. 3, 2023. About STARLIGHT 2 About STARLIGHT 3 About VMS About Fezolinetant About Astellas Cautionary Notes References 1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. 3 Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. Przegl Menopauzalny [Menopause Rev]. 2014;13:203-211. 4 Gold EB, Colvin A, Avis N, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006;96:1226-1235. 5 Tomida M, Otsuka R, Tange C, et al. Vasomotor symptoms, sleep problems, and depressive symptoms in community-dwelling Japanese women. J Obstet Gynaecol Res. 2021 Oct;47(10):3677-3690. doi: 10.1111/jog.14937. Epub 2021 Jul 18. PMID: 34278662; PMCID: PMC9291044. 6 NHK World-Japan. Survey on Menopause and Work 2021: Summary of Results. https://www.jil.go.jp/tokusyu/covid-19/collab/nhk-jilpt/docs/20211103-nhk-jilpt.pdf 7 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905. 8 Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392. 9 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225. View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-initiates-phase-3-clinical-studies-of-fezolinetant-for-vms-associated-with-menopause-in-japan-302077555.html SOURCE ASTELLAS PHARMA INC. |
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