For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. [2] Phase IIa trials in polycystic ovary syndrome patients are ongoing. Regarding AT132, we submitted a series of responses to clinical hold by FDA by -- in March. Fezolinetant is an investigational oral . Our communications team will respond to verified media requests within 24-48 hours as appropriate. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2, "In the United States, 60% to 80% of individuals experience VMS during or after the menopausal transition, with limited nonhormonal treatment options," said Ahsan Arozullah,M.D., M.P.H.,Senior Vice President and Head of Development Therapeutic Areas, Astellas. Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The product details cover mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. Colleen Williams Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science intoVALUE for patients. 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Help us improve the Therapeutic Goods Administration site. This website provides access to information from Astellas sponsored clinical trials and the purpose is not to promote or advertise any Read about our latest progress around our Corporate Strategic Plan. It is being developed by Astellas. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. It is being developed by Astellas. Astellas' eyes filings for menopause drug fezolinetant after ph3 win ", "Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area," said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology.
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