Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause. Fezolinetant is an oral, nonhormonal therapy that works by blocking neurokinin B (NKB) binding on the KNDy neuron to moderate neuronal activity in the hypothalamus to reduce the frequency and severity of symptoms associated with menopause. The report provides the clinical trials information of Fezolinetant (ESN364) covering trial interventions, trial conditions, trial status, start and completion dates. The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. 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. The Institute for Clinical and Economic Review stated fezolinetant's evidence is rated as promising but inconclusive to determine whether fezolinetant provides a net health benefit for patients over the long term; however, using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 . Before Seagen's $43 billion deal to be acquired by Pfizer last month, the biotech company had received takeover offers going back to at least 2019, according to a new filing that provides a play . Waltham, MA: Elsevier, 2014:120. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the . 2014;13:203-211. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . 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. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. 2019;104:5893-5905. Laura Wood, Senior Press Manager 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. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2,3 The safety and efficacy of fezolinetant are under investigation and have not been established. News | Astellas Pharma Inc. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Fezolinetant (ESN364) Analytical Perspective, In-depth Fezolinetant (ESN364) Market Assessment. Fezolinetant | C16H15FN6OS | CID 117604931 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. News | Astellas Pharma Inc. Endocrinology. [6][7], Unlike GnRH modulators, but similarly to estrogens, NK3 receptor antagonists including fezolinetant and MLE-4901 (also known as AZD-4901, formerly AZD-2624) have been found to alleviate hot flashes in menopausal women. Astellas Provides Update on Fezolinetant New Drug Application in U.S. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. 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. Date Article; Mar 13, 2023: Results from Astellas' Pivotal Phase 3 SKYLIGHT 1 Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet: Feb 20, 2023: Astellas Provides Update on Fezolinetant New Drug Application in U.S. Aug 18, 2022: U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant: Jun 23, 2022 We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. The Endocrine News podcast brings you the latest research and clinical advances from experts in the field, whether you are in your car, office, or out for a run. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. Astellas Provides Update on Fezolinetant New Drug Application in U.S. The report also features the SWOT analysis with analyst insights and key findings of Fezolinetant (ESN364). Our top-ranked peer-reviewed journals are among the first to publish major developments and discovery milestones. Padcev (enfortumab vedotin) is the first Nectin-4-directed antibody-drug conjugate (ADC) approved for the treatment of advanced urothelial cancer, the most common form of bladder cancer.. The website you are about to visit is not owned or controlled by Astellas. FDA to Review NDA for Nonhormonal Therapy for Menopause [emailprotected]. Endocrinology. Menopause. 4Gold EB, Colvin A, Avis N, et al. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030", https://www.researchandmarkets.com/r/q7m5ni. Fezolinetant in Hot Flashes - Clinical Trials Registry - ICH GCP About VMS Associated with Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS and, in the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition.3,4,5,6VMS can have a disruptive impact on women's daily activities and overall quality of life.1, About FezolinetantFezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Our communications team will respond to verified media requests within 24-48 hours as appropriate. 2008;11:32-43. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. All rights reserved. 2015;156:4214-4225. The Society has more than 18,000 members, including scientists, physicians, educators, nurses, and students in 122 countries. The website you are about to visit is not owned or controlled by Astellas. The new PDUFA date is set for May 22. 2014;21:924-932. Elinzanetant. 2006;96:1226-1235. SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase III clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. Fezolinetant is an oral, nonhormonal therapy that works by . The PDUFA date is Feb 22, 2023. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets.