There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Am J Public Health. If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. 2014;21:924-32. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. At week 12, fezolinetant significantly reduced total VMS score vs placebo (-26.5 vs -12.2, P < 0.001) and decreased mean frequency of moderate/severe VMSs by five episodes per day vs placebo. For U.S./CAN Toll Free Call 1-800-526-8630 Hot flashes can interrupt a woman's daily life. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Other emerging products for Vasomotor symptoms are giving market competition to Fezolinetant (ESN364) and launch of late-stage emerging therapies in the near future will significantly impact the market. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. The trials are double-blinded and placebo-controlled for the first 12 weeks followed by 40-week active treatment extension period. Menopause, a normal part of aging, is the time of a woman's last period. 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. 2020;27:382-92. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. 1.3 Details of the supplier of the safety data sheet Company: MedChemExpress USA Tel: 609-228-6898 Fax: 609-228-5909 The report provides the clinical trials information of Fezolinetant (ESN364) covering trial interventions, trial conditions, trial status, start and completion dates. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderates levels of ovarian hormones throughout the menstrual cycle. 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. Endocrine Society is a global community of physicians and scientists dedicated to accelerating scientific breakthroughs and improving patient health and well being. 2006;96:1226-35. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 3 Fraser GL, Hoveyda HR, Clarke IJ, et al. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. Price : $50 * Buy Profile. Phil Taylor. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. By using this site, you accept our use of cookies as described in our privacy policy. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. Astellas booked 13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022. . Women were enrolled at over 280 sites within the U.S.,CanadaandEurope. In 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. What is the technology utilized in the development of Fezolinetant (ESN364)? The SKYLIGHT 4 findings, along with the results from two pivotal Phase 3 clinical trials, SKYLIGHT 1 and SKYLIGHT 2, will provide the foundational data for regulatory submissions in the U.S. and Europe. 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. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes. Fezolinetant is an antagonist of the GPCR known as the tachykinin NK3 receptor and acts on specific neurons that control body temperature to mimic the effects of estrogen, but in a non-hormonal manner, to directly and safely address the basis for HF in menopausal women. For media inquiries and reporter requests, please click here to fill out a request form. 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. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. TOKYO, March 7, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced topline results from the Phase 3 SKYLIGHT 4 clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with . For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. 2019;104:5893-5905. Fezolinetant is under clinical development by Astellas Pharma and currently in the Pre-Registration in clinical pathway. The website you are about to visit is not owned or controlled by Astellas. Fezolinetant (ESN364) Clinical Assessment. For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. MOONLIGHT 1 is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. Active ingredients. 2015;156:4214-4225. Fezolinetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, associated with menopause, according to a Phase 3 industry-sponsored study being presented Saturday at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga. Senior Communications Manager, Public Relations, Director, Communications and Media Relations. What are the other emerging products available and how these are giving competition to Fezolinetant (ESN364)? 4th ed. 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. 2008;11:32-43. 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. Any information on the products contained herein is not intended to provide medical advice nor should be used as a substitute for the advice provided by your physician or other healthcare provider. 2Fraser GL, Lederman S, Waldbaum A, et al. fezolinetant. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. from 8 AM - 9 PM ET. 6Williams RE, Kalilani L, DiBenedetti DB, et al. Endocrinology. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Elinzanetant. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Is there anything wrong with this page? [1] [2][3], As of May 2017, it has completed phase I and phase IIa clinical trials for hot flashes in postmenopausal women. 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. 2019;104:5893-5905. This report provides a detailed market assessment of Fezolinetant (ESN364) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. [2], In March 2023, results from SKYLIGHT 1, a Phase III clinical study of the treatment of moderate to severe hot flashes due to menopause were published in The Lancet. Endocrinology. 4th ed. What is the product type, route of administration and mechanism of action of Fezolinetant (ESN364)? today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug . Faslodex is available as a solution for injection in prefilled syringes (250 mg). The report also highlights the drug research and development activity details across the United States, Europe and Japan. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. J ClinEndocrinol Metab. To learn more about the Society and the field of endocrinology, visit our site atwww.endocrine.org. 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. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Sorry, you need to enable JavaScript to visit this website. What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Fezolinetant (ESN364) development? This segment of the report provides forecasted sales data from 2020 to 2030. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor . The dose is given as two injections, each given into the muscle of one buttock over one to two minutes. Improvements were achieved in all quality-of-life . The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. 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. 2014;21:924-932. 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 study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of . Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded and placebo-controlled study designed to investigate long-term safety of fezolinetant. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant", Astellas Enters into Definitive Agreement to Acquire Iveric Bio, Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Director, Communications and Media Relations Przegl Menopauzalny [Menopause Rev]. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. The safety and efficacy of fezolinetant are under investigation and have not been established. 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. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. 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. Product name : Fezolinetant Catalog No. Time Frame: From first dose date up to 21 days after last dose (up to 55 weeks) 2022624FDAfezolinetantNDA (VMS) Fezolinetant 3 (NK3) first-in-class VMS Fezolinetant (INN; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development by for the treatment of sex hormone-related disorders. SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase 3 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. "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. Menopause, a normal part of aging, is the time of a woman's last period. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. 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. Our top-ranked peer-reviewed journals are among the first to publish major developments and discovery milestones. Przegl Menopauzalny [Menopause Rev]. Menopause. Detailed results will be submitted for publication and for consideration at upcoming medical meetings. 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. Feb-23. "We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will . Menopause. [6] As such, they are similar to GnRH modulators, and present as a potential clinical alternative to them for use in the same kinds of indications. What is the forecasted market scenario of Fezolinetant (ESN364)? . Which are the late-stage emerging therapies under development for the treatment of Vasomotor symptoms.