The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions. Climacteric. ET. Climacteric. For more information, please visit our website at https://www.astellas.com/en. 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. Astellas was notified on February 17, 2023, that the FDA is extending the PDUFA goal date by three months, to May 22, 2023, to allow more time to complete their review. 2006;96:1226-35. This in-depth analysis of the forecasted sales data of Fezolinetant (ESN364) from 2020 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Fezolinetant (ESN364). The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Hot flashes can interrupt a woman's daily life. Przegl Menopauzalny [Menopause Rev]. Adis is an information provider. 2014;13:203-211. J ClinEndocrinol Metab. What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Fezolinetant (ESN364) development? California Declaration of Comprehensive Compliance Program, Vermonts Pharmaceutical Marketer Price Disclosure, Wholesale Acquisition Cost Information for Colorado Prescribers, Consumer Product Safety Commission Regulations, the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant", Understanding the Gastric and GEJ Cancer Landscape. "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 continue to work with the FDA on its review of the NDA for . 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. Am J Public Health. 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. Menopause. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. 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 2015;156:4214-4225. Treatment for: Menopausal Disorders, Hot Flashes. fezolinetant. 2006;96:1226-1235. Faslodex can only be obtained with a prescription. The study's primary objectives were to evaluate the effect offezolinetanton endometrial health and the long-term safety and tolerability of fezolinetant. 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. The drug is indicated for locally advanced or metastatic urothelial cancer patients who have previously been treated with platinum-containing chemotherapy or programmed cell death ligand 1 (PD-1) or PD-L1 . Astellas was notified on February 17, 2023, that the FDA is extending the PDUFA goal date by three months, to May 22, 2023, to allow more time to complete their review. About FezolinetantFezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women's health disorders. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). At the 45 mg dose, fezolinetant showed a -2.55 (p=<0.001) and -2.53 (p=<0.001) mean change per day in VMS frequency versus placebo at weeks 4 and 12, respectively. 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. . For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. Health Qual Life Outcomes. Is there anything wrong with this page? 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. Bayer acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020, while Astellas acquired fezolinetant as part of its 2017 takeover of Ogeda. M.D., senior vice president and head of development therapeutic areas at Astellas, said in a press release. In the coming years, the market scenario for Vasomotor symptoms is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. For the co-primary endpoint of reduction in mean frequency of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -1.82 (p=<0.001) and -1.86 (p=<0.001) mean change per day at . 2Jones RE, Lopez KH, eds. 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. Atlanta, GA June 11, 2022. 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 4clinical 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 menopause (VMS) which will support future regulatory filing submissions. The impact of this matter on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. Przegl Menopauzalny [Menopause Rev]. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. C[C@@H]1C2=NN=C(N2CCN1C(=O)C3=CC=C(C=C3)F)C4=NC(=NS4)C, InChI=1S/C16H15FN6OS/c1-9-13-19-20-14(15-18-10(2)21-25-15)23(13)8-7-22(9)16(24)11-3-5-12(17)6-4-11/h3-6,9H,7-8H2,1-2H3/t9-/m1/s1, List of investigational sex-hormonal agents GnRH/gonadotropins, "Optimization of Novel Antagonists to the Neurokinin3 Receptor for the Treatment of Sex-Hormone Disorders (Part II)", "Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study", "A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause", "The NK3 Receptor Antagonist ESN364 Suppresses Sex Hormones in Men and Women", "The NK3 Receptor Antagonist ESN364 Interrupts Pulsatile LH Secretion and Moderates Levels of Ovarian Hormones Throughout the Menstrual Cycle", "Gone in a Flash: New Drug Class Targets Menopause Symptom", "Ogeda Announces Positive Data From Phase IIa Trial Of Fezolinetant In The Treatment Of Menopausal Hot Flashes", https://en.wikipedia.org/w/index.php?title=Fezolinetant&oldid=1147159156, Chemical pages without DrugBank identifier, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License 3.0, This page was last edited on 29 March 2023, at 06:05. What are the other emerging products available and how these are giving competition to Fezolinetant (ESN364)? For U.S./CAN Toll Free Call 1-800-526-8630 The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. Additionally, for the co-primary endpoint of reduction in mean severity of moderate to severe VMS versus placebo, fezolinetant 30 mg demonstrated a -0.15 (p=<0.021) and -0.16 (p=0.049) mean change per day at weeks 4 and 12 . Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. 6Williams RE, Kalilani L, DiBenedetti DB, et al. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Ces symptmes ont un impact important sur le sommeil et la qualit de vie. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. For media inquiries and reporter requests, please click here to fill out a request form. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Colleen Williams Comprehensive coverage of the late-stage emerging therapies (Phase III) for Vasomotor symptoms. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Read about our historyand how we continue to serve the endocrine community. 1 Depypere H, Timmerman D, Donders G, et al. 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. About BRIGHT SKY Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), enrolled over 1,020 women with moderate to severe VMS. Fezolinetant is an investigational oral . 2 Fraser GL, Lederman S, Waldbaum A, et al. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. 2014;13:203-211. 2020;27:382-92. For media inquiries and reporter requests, please click here to fill out a request form. Endocrine Society is a global community of physicians and scientists dedicated to accelerating scientific breakthroughs and improving patient health and well being. 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. [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. 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. Joanne Fagg. Menopause. The safety and efficacy of fezolinetant are under investigation and have not been established. 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. Our top-ranked peer-reviewed journals are among the first to publish major developments and discovery milestones. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. By using this site, you accept our use of cookies as described in our privacy policy. 4th ed. Les symptmes vasomoteurs de la mnopause (SVM), en premier lieu les bouffes de chaleur, touchent une large proportion des femmes (> 80 %) lors de la primnopause, et dix ans plus tard 30 % 50 % en souffrent toujours. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. Just days before the approval decision date, the FDA has extended the review by three months to give it more time to complete its assessment. Health Qual Life Outcomes. What is the forecasted market scenario of Fezolinetant (ESN364)? For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. 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 . For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. It is being developed by Astellas. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. "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 continue to work with the FDA on its review of the NDA for fezolinetant," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 2015;156:4214-4225. For E.S.T Office Hours Call 1-917-300-0470 Menopause, a normal part of aging, is the time of a woman's last period. 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. Please read our privacy policy for more information on the cookies we use, the processing of your personal data and how to delete or block the use of cookies. The report provides the clinical trials information of Fezolinetant (ESN364) covering trial interventions, trial conditions, trial status, start and completion dates. Astellas Provides Update on Fezolinetant New Drug Application in U.S. For further information: Contacts for inquiries or additional information: Astellas Portfolio Communications, Anna Criddle, +1 (847) 682-4812, anna.criddle@astellas.com, Astellas Pharma Inc. Corporate Advocacy & Relations, +81-3-3244-3201. Language links are at the top of the page across from the title. 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. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life.1. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies. 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. Fezolinetant is an oral, nonhormonal therapy that works by . 9Fraser GL, Hoveyda HR, Clarke IJ, Ramaswamy S, Plant TM, Rose C, et al. Phase 3 study finds fezolinetant reduces the frequency and severity of menopausal hot flashes. 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. This website contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, or in different dosages. 2022624FDAfezolinetantNDA (VMS) Fezolinetant 3 (NK3) first-in-class VMS 2 Jones RE, Lopez KH, eds. The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). 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 . A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Sorry, you need to enable JavaScript to visit this website. By using this site, you accept our use of cookies as described in our privacy policy. Contacts. 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. 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 . Elinzanetant (developmental code names BAY-3427080 GSK-1144814, NT-814) is an orally active small-molecule neurokinin/tachykinin NK 1 receptor and NK 3 receptor antagonist which is under development by Bayer, GlaxoSmithKline, and NeRRe Therapeutics for the treatment of hot flashes and "sex hormone disorders". SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded and placebo-controlled study designed to investigate long-term safety of fezolinetant. Astellas are not responsible for the information or services on this site. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. Which company is developing Fezolinetant (ESN364) along with the phase of the clinical study? Fezolinetant ( INN; former developmental code name ESN-364) is a small-molecule, orally active, selective neurokinin-3 (NK 3) receptor antagonist which is under development by for the treatment of sex hormone -related disorders. Fezolinetant works by blocking neurokinin B (NKB . 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. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. 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 . Endocrinology. Product name : Fezolinetant Catalog No. The study treatments are fezolinetant 30 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. 2020;27:382-392. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Astellas is reviewing the financial impacts of this submission for the fiscal year ending March 31, 2023. 2005;3:47. Follow us on Twitter at@TheEndoSocietyand@EndoMedia. On estime la dure moyenne des SVM 7,4 ans. 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. Human Reproductive Biology. 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. For more information about this report visit https://www.researchandmarkets.com/r/q7m5ni, ResearchAndMarkets.com 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. 6Williams RE, Kalilani L, DiBenedetti DB, et al. today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug . Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. 4th ed. Available for Android and iOS devices. . Feb-2023. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. 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 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. "The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. This website contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, or in different dosages. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, Astellas Submits Fezolinetant New Drug Application to U.S. FDA. 2Fraser GL, Lederman S, Waldbaum A, et al. 1Utian WH. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. Fezolinetant (ESN364) is a Neurokinin 3 receptor antagonists under development for the treatment of Vasomotor symptoms. 2008;11:32-43. Fezolinetant - Ogeda Alternative Names: A2693; AS3472693-00; ESN-364 Latest Information Update: 15 Mar 2023. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS due to menopause. Improvement in VMS frequency and severity observed through week 12 (statistically significant differences vs placebo) was maintained throughout the 52-week total study period for those receiving fezolinetant. [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. 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. However, Apellis might not have the market to itself for long as Iveric Bio's Zimura has a Pdufa date in August. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Menopause. 2015;156:4214-25. 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. 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. When typing in this field, a list of search results will appear and be automatically updated as you type. Find out more about how we use your personal data in our privacy policy and cookie policy. If you would like to customise your choices, click 'Manage privacy settings'. What is the history of Fezolinetant (ESN364) and what is its future? Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. 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. 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. . What are the key designations that have been granted to Fezolinetant (ESN364)? The safety and efficacy of fezolinetant are under investigation and have not been established. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant"issued on August 18, 2022. Sorry, you need to enable JavaScript to visit this website. Waltham, MA: Elsevier, 2014:120. Faslodex is available as a solution for injection in prefilled syringes (250 mg). 2019;104:5893-5905. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of VMS associated with menopause. 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.