Japan-based Astellas Pharma has filed a New Drug Application for fezolinetant, an investigational selective neurokinin 3 (NK3) receptor antagonist developed for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Nothing contained herein should be considered a solicitation, promotion or advertisement for any drug including those under development. Astellas are not responsible for the information or services on this site. The report provides the clinical trials information of Fezolinetant (ESN364) covering trial interventions, trial conditions, trial status, start and completion dates. 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. Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT BREAKING: Fezolinetant news - Hotflash Inc For U.S./CAN Toll Free Call 1-800-526-8630 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, [email protected], Astellas Pharma Inc. Corporate Advocacy & Relations, +81-3-3244-3201. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded and placebo-controlled study designed to investigate long-term safety of fezolinetant. 2 Jones RE, Lopez KH, eds. J ClinEndocrinol Metab. 4Gold EB, Colvin A, Avis N, et al. The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155)and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. 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. fezolinetant "Fezolinetant (ESN364) - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets. "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 . Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. For more information, please visit our website at https://www.astellas.com/en. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. For GMT Office Hours Call +353-1-416-8900, Internet Explorer presents a security risk. 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. About the launch of fezolinetant, it will not be the linear . The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. The Society has more than 18,000 members, including scientists, physicians, educators, nurses, and students in 122 countries. Our communications team will respond to verified media requests within 24-48 hours as appropriate. Feb-2023. Select one or more newsletters to continue. The report also covers the patents information with expiry timeline around Fezolinetant (ESN364). PDF Supplementary appendix Find out more about how we use your personal data in our privacy policy and cookie policy. Ogeda announces fezolinetant as INN and issuance of U.S. 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. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S.,CanadaandEurope. Accepted date. Thesafety and efficacy of fezolinetant are under investigation and have not been established. J ClinEndocrinol Metab. 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. 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. For 100 years, the Endocrine Society has been at the forefront of hormone science and public health. [email protected] 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. NK3!FDA Fezolinetant Fezolinetant: A Non-Hormonal Treatment for Hot Flashes 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. Menopause. The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Astellas proposes a 45 mg daily dose. 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. 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. If you are not a reporter and need assistance, please visit our contact us page that includes information for patients, healthcare providers and researchers. Endocrinology. Menopause. 3Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause - an intercontinental review. Language links are at the top of the page across from the title. What is the forecasted market scenario of Fezolinetant (ESN364)? Astellas Provides Update on Fezolinetant New Drug Application in U.S. Proposed indication. 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. This website is intended for U.S. residents only. 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. 2019;104:5893-5905. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderates levels of ovarian hormones throughout the menstrual cycle. Fezolinetant is an oral, nonhormonal therapy that works by . For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022. Fezolinetant - Ogeda - AdisInsight U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant, For further information: Astellas Portfolio Communications: Anna Otten, +1 (847) 682-4812, [email protected]; Astellas Pharma Inc. Corporate Advocacy & Relations: +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 product details cover mechanism of action, dosage and administration, route of synthesis, and Research and development activity including regulatory milestones, and other development activities. 2Jones RE, Lopez KH, eds. 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. 4 bWomen aged 40-65 years with a minimum average of 7 moderate-to-severe hot flashes per day were randomised to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg (ratio 1:1:1). 3Fraser GL, Hoveyda HR, Clarke IJ, et al. Time Frame: From first dose date up to 21 days after last dose (up to 55 weeks) Hot flashes can interrupt a woman's daily life. Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. . The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 2006;96:1226-35. . 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. 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 . The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. 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. 4th ed. 2014;21:924-932. News | Astellas Pharma Inc. Astellas are not responsible for the information or services on this site. 7Depypere H, Timmerman D, Donders G, Sieprath P, Ramael S, Combalbert J, et al. Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. Contacts Jean Combalbert: Ruth Devenyns: Chief Executive Officer: Chief Financial Officer +32 71 348 520 +32 71 348 500: [email protected] : [email protected] : Consilium Strategic Communications [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. 8Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, et al. : HY-19632 CAS No. Genevieve Neal-Perry, MD, PhD, discusses her research on fezolinetant as a treatment for hot flashes. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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 . J Clin Endocrinol Metab. Astellas Submits Fezolinetant New Drug Application to U.S. FDA Fezolinetant is an investigational oral . SKYLIGHT 4 study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1and SKYLIGHT 2, and the Phase 3 long-term safety study, SKYLIGHT 4. 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. It is being developed by Astellas. 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. MOONLIGHT 1 is an ongoing randomized Phase 3 clinical trial evaluating the efficacy and safety of fezolinetant in 302 women in China, Korea and Taiwan who take fezolinetant 30 mg QD for 24 weeks . Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9.