Language links are at the top of the page across from the title. DUBLIN--(BUSINESS WIRE)--The "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. Menopause. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Human Reproductive Biology. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. Vasomotor SymptomsVMSfezolinetant . Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Which company is developing Fezolinetant (ESN364) along with the phase of the clinical study? With the trio of trials now complete, Astellas says it can press ahead with regulatory filings for the new drug, keeping its nose ahead of its main rival Bayer, which paid $425 million upfront to . Astellas are not responsible for the information or services on this site. 2005;3:47. The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. Endocrinology. The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause, For further information: Contacts for inquiries or additional information: Astellas Portfolio Communications: Anna Otten, TEL: +1 (847) 682-4812, anna.otten@astellas.com; Astellas Pharma Inc., Corporate Advocacy & Relations, TEL: +81-3-3244-3201, California Declaration of Comprehensive Compliance Program, Vermonts Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, Understanding the Gastric and GEJ Cancer Landscape. Proposed indication. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Faslodex is available as a solution for injection in prefilled syringes (250 mg). Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. 2008;11:32-43. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Randomisation was double-blind and the randomisation number was assigned based on information obtained from Interactive Response A (new medicine) Publication date. It is being developed by Astellas. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Feb-23. TOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. [emailprotected], Jenni Glenn Gingery There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
