This phase II trial tests how well fezolinetant works in improving vasomotor symptoms (VMS) in breast cancer patients taking endocrine therapy (ET). Anti-hormone treatments are effective for lowering the risk of breast cancer but can cause bothersome VMS, such as hot flashes and night sweats. Fezolinetant inhibits the activity of the neurokinin type 3 receptor and has shown activity against VMS in postmenopausal women. Taking fezolinetant may work well at improving VMS in breast cancer patients taking ET.

开始日期2024-10-31

申办/合作机构

Rogel Cancer Center: University of Michigan

[+1]

NCT06440967 / Recruiting临床3期

A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it.
The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo.
Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall).
The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. This will include some blood and urine tests. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo).

开始日期2024-07-31

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT06206421 / Recruiting临床3期

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed.
Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment.
Women will either take fezolinetant or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks.
During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). At each visit they will be asked if they had any medical problems. Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the placebo).

开始日期2024-02-22

申办/合作机构

Astellas Pharma, Inc.

100 项与非唑奈坦相关的临床结果

登录后查看更多信息

100 项与非唑奈坦相关的转化医学

登录后查看更多信息

100 项与非唑奈坦相关的专利（医药）

登录后查看更多信息

项与非唑奈坦相关的文献（医药）

2024-12-01·Archives of women's mental health

FDA approved fezolinetant (Veozah): a critical evaluation of its efficacy and safety for menopausal vasomotor symptoms, calling for prospective research

Article

作者: Rani, Payal ; Rani, Priya ; Mansoor, Malaika ; Zehra, Dua

Women going through menopause frequently experience vasomotor symptoms such as hot flashes, night sweats, and sleep disturbances, significantly influencing their quality of life. Hormonal therapy has been demonstrated to be beneficial in treating VMS. However, due to specific restrictions, it is not recommended for every woman. Fezolinetant, a neurokinin 3 antagonist and non-hormonal treatment for severe to moderate VMS, functions by inhibiting neuronal impulses originating from the hypothalamic thermoregulatory center. Current Skylight 2 and 4 trials statistically demonstrate the safety and acceptability of fezolinetant, with relatively few adverse effects reported. Fezolinetant has been shown great potential for treating menopausal-related VMS, supporting its further advancement. However, further investigation is required to thoroughly evaluate its safety, effectiveness, and its impact on sleep patterns.

2024-11-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Non-hormonal pharmacological interventions for managing vasomotor symptoms-how can we help: 2024 landscape

Review

作者: Pertynska-Marczewska, Magdalena ; Pertynski, Tomasz

BACKGROUND:

Vasomotor symptoms (VMS) affect 70% of menopausal women and are considered as hallmark symptoms of the menopausal transition experienced by over three quarters of women and severely by 25% of women. Estrogen withdrawal alone is not fully responsible for the onset of the menopausal vasomotor symptoms and the mechanism of altered thermoregulation appears to be centrally mediated with alterations in hypothalamic neurotransmitters playing a key part. The loss of thermoregulatory control coexists with the altered Kisspeptin- Neurokinin B-Dynorphin-expressing (KNDy) neurons of the arcuate nucleus signaling triggered by menopause.

OBJECTIVE:

Aim of the review was to explore evidence-based non-hormonal pharmacological interventions for treating vasomotor symptoms.

METHODS:

Comprehensive overview of relevant literature.

CONCLUSIONS:

In the population where, hormonal options are contraindicated or not preferred by the patient, it is essential to explore evidence-based non-hormonal pharmacological interventions for treating vasomotor symptoms. The 2024 landscape of available treatments has expanded yet again, arming the providers with an even wider range of possibilities to help their patients. Fezolinetant, is the first NK3R antagonist developed for the purpose of treating hot flashes in menopausal women. NK3R antagonists provide a safe and effective treatment option for managing menopausal women with VMS.

2024-09-30·Cureus Journal of Medical Science

Available Treatments and Adjunctive Therapies for Polycystic Ovarian Syndrome (PCOS) Patients of Reproductive Age: A Scoping Review

Review

作者: Garcia, Kristen ; Yagoda, Alexis ; Prol, Barbara ; Costin, Joshua M ; Dressel, Jordan ; Nadolny, Riley ; Shipp, Arianne ; Gandhi, Prachi ; Cochran, Lisa ; Peralta, Ria ; Kluglein, Kimberly A

Polycystic ovarian syndrome (PCOS) impacts the health of women worldwide. It is a condition consisting of dysfunctional cystic ovaries resulting in hormonal imbalance. Many women have symptoms such as infertility, increased production of androgens, and insulin resistance. Barriers to effective treatment of PCOS include issues such as delays in diagnosis and inconsistencies in treatment plans among physicians. Despite the current use of available medications to decrease symptomatology, women with PCOS continue to report a decreased quality of life. Using the electronic databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and ScienceDirect, a scoping review was conducted on the globally available treatments for PCOS. After applying pre-determined inclusion criteria, 41 studies were included in this scoping review. The literature on the available treatments for PCOS revealed a wide range of therapeutics with evidence of reduction of symptoms and/or improvement in fertility status and pathological processes such as insulin resistance, hormone imbalance, obesity, inflammation, and infertility. Dozens of treatment options for PCOS have been identified, including new medications and modifications to existing treatment regimens. The hormonal drug Fezolinetant demonstrated effective suppression of hyperandrogenism. Drugs used to treat diabetes, such as Liraglutide, were found effective for weight loss. Green cardamom, cinnamon, and other supplements proved effective in treating metabolic dysfunction. Alternative approaches, such as osteopathic manipulative therapy and acupuncture, decreased sympathetic tone and androgen levels. This review provides a succinct overview of PCOS therapies that can be used by those with PCOS and their physicians everywhere. With a better understanding of their options, women with PCOS can become more involved in the decision-making process to improve their health. More research is needed on novel therapies that aim to reduce the primary pathogenesis of PCOS.

160

项与非唑奈坦相关的新闻（医药）

2024-11-04

·安斯泰来中国

安斯泰来公布2024财年前6个月财务业绩

安斯泰来制药集团（TSE:4503）近日发布了2024财年前6个月全球财务业绩（2024财年前6个月为2024年4月1日至2024年9月30日）。用于前列腺癌治疗的XTANDI、用于尿路上皮癌治疗的PADCEV以及用于急性髓系白血病治疗的XOSPATA销售额均表现出稳健增长。此外，用于缓解更年期血管舒缩症状的VEOZAH和用于治疗与年龄相关的黄斑变性所致地理萎缩的IZERVAY，这两款于上财年推出的产品也推动了收入的增长。最终2024财年前六个月营业收入为：9,356亿日元，较上一财年同期同比增长22.0%，核心营业利润为1,831亿日元，同比增长36.2%。主要增长引擎 XTANDI 销售额同比增长25.1% 达到4,517亿日元 PADCEV 销售额同比增长130.5% 达到754亿日元 XOSPATA 销售额同比增长32.3% 达到348亿日元 VYLOY 2024年6月在日本上市，销售额大幅增长，达到12亿日元 VEOZAH1 全球销售额稳步增长达到148亿日元 Betanis /Myrbetriq /BETMIGA 销售额同比减少19.1% 销售额为775亿日元 Prograf2 全球销售额同比增长3.9% 达到1,039亿日元 IZERVAY 在美国上市，销售额超出预期达到281亿日元稳定投资未来成长 2024财年前6个月的研发费用为1,723亿日元，同比增长21.4%。中国区3稳步增长得益于XTANDI、XOSPATA等包括肿瘤药在内的产品组合展现的强大潜力。中国商业区实现收入377亿日元，为全球业绩增长贡献了力量。安斯泰来将致力于实现我们的愿景：将科学的进步转变为患者的价值，并对未来的稳定增长充满信心。延伸阅读中国国家药品监督管理局批准备思复（注射用维恩妥尤单抗）用于治疗局部晚期或转移性尿路上皮癌中国国家药品监督管理局批准安可坦（XTANDI，恩扎卢胺）治疗转移性激素敏感性前列腺癌的新适应症日本厚生劳动省批准备思复（维恩妥尤单抗）联合可瑞达（帕博利珠单抗）用于一线治疗不可根治性切除的尿路上皮癌安斯泰来 VYLOY (zolbetuximab-clzb) 获美国 FDA 批准用于治疗晚期胃和胃食管交界处(GEJ)腺癌注释 1- VEOZAH: Approved as “VEOZA” in ex-US 2-PROGRAF: Includes ADVAGRAF, GRACEPTOR, and ASTAGRAF XL. 3-中国区包括:中国大陆地区和香港地区

财报抗体药物偶联物

2024-10-29

·安斯泰来中国

安斯泰来在IMS世界更年期大会上展示VEOZA™️（fezolinetant）数据

在10月19日至22日于澳大利亚墨尔本举行的国际绝经协会（IMS）第19届世界绝经大会上，安斯泰来治疗绝经相关中重度血管舒缩症状（VMS）的同类首创药物VEOZA™（fezolinetant）*在四场口头报告和两张壁报展示。VMS，也称为潮热和/或盗汗，是绝经的常见症状。1,2 安斯泰来副总裁兼生物制药开发负责人 Marci English “Astellas致力于推进创新科学，世界绝经大会上的数据进一步加深了我们对VMS如何影响个人和女性治疗偏好的理解。此外，我们很高兴分享我们最近启动的HIGHLIGHT研究的试验设计，该研究旨在评估fezolinetant用于治疗接受辅助内分泌治疗的乳腺癌症患者中度至重度VMS。” 医学博士、安斯泰来副总裁兼医学事务特药治疗领域负责人 Emad Siddiqui “我们致力于在关键试验之外继续扩大对fezolinetant的了解。我们在世界绝经大会上的演讲包括广泛的临床和健康相关的生活质量分析，进一步强调了fezolinetant的安全性和有效性，以及它对患者报告结局（包括睡眠和工作效率）的积极影响。” Fezolineant数据在四场口头报告和两张壁报中呈现： •SKYLIGHT 1和2研究的两场口头报告侧重于患者报告的睡眠结果以及Fezolinetant对工作效率的影响。 •DAYLIGHT研究的两场口头报告侧重在Fezolinetant用于不适合激素治疗的女性，包括药物应答和生活质量。 •壁报强调了对临床和非临床数据的分析，这些数据表明Fezolinetant治疗与恶性肿瘤发病率之间没有关联。 •壁报还包括了最近启动的3期临床研究-HIGHLIGHT 1的研究设计，旨在评估Fezolinetant用于正接受辅助内分泌治疗的0至3期激素受体阳性的乳腺癌患者中度至重度VMS的疗效和安全性。另外两场口头报告强调了澳大利亚女性对与绝经相关的VMS治疗的偏好，以及一项文献综述的结果，该文献综述旨在确定和描述与个体VMS经历相关的概念，目的是为开发一种文化敏感的VMS自我评估工具提供信息。 *VEOZA：在美国被批准为“VEOZAH™”。向下滑动查看更多▼ 关于BRIGHT SKY™第三阶段项目 BRIGHT SKY关键试验SKYLIGHT 1™（NCT04003155）和SKYLIGHT 2™（NCT04003142）招募了1000多名患有中度至重度VMS的绝经女性。试验在前12周采用双盲、安慰剂对照，然后接受40周的扩展期治疗。入组患者来自美国、加拿大和欧洲的180多个研究中心。SKYLIGHT 4™（NCT04003389）是一项为期52周的双盲安慰剂对照研究，旨在研究Fezolinetant的长期安全性。对于SKYLIGHT 4，在美国、加拿大和欧洲的180多个研究中心招募了超过1800多名患有VMS的绝经妇女。关于DAYLIGHT DAYLIGHT（NCT05033886）是一项临床3b研究，为期24周的随机、双盲、安慰剂对照研究，旨在评估Fezolinetant对40-65岁患有中度至重度VMS且被认为不适合激素治疗的绝经女性的疗效和安全性。在加拿大、欧洲和土耳其的69个研究中心共入组453名女性。关于HIGHLIGHT 1TM HIGHLIGHT 1（NCT06440967）是一项随机、安慰剂对照、双盲、3期临床研究，旨在评估在接受辅助内分泌治疗的0至3期激素受体阳性乳腺癌症患者中， fezolinetant用于治疗中度至重度VMS的有效性和安全性。计划在欧洲和加拿大的100多个研究中心，约有540名患者入组，1:1随机分配到fezolinetant治疗组或安慰剂组。四个共同的主要终点是从基线至第4周和第12周，中重度VMS发生频率和严重程度的变化。患者将接受52周的治疗，并在55周时进行最终评估。关于VEOZATM（fezolinetant） VEOZA（fezolinetant）是一款非激素神经激肽3（NK3）受体拮抗剂，在澳大利亚用于治疗与绝经相关的中重度血管舒缩症状（潮热和盗汗）。VEOZA通过阻断神经激肽B（NKB）与kisspeptin/神经激肽/强啡肽（KNDy）神经元的结合来调节大脑温度控制中心（下丘脑）的神经元活动，从而减少潮热和盗汗的频率和严重程度。3,4,5 重要安全信息关于fezolinetant 的完整澳大利亚产品信息和澳大利亚公众评估报告（AusPAR）可从澳大利亚政府治疗用品管理局获得。澳大利亚产品信息： https://www.tga.gov.au/sites/default/files/2024-05/auspar-veoza-240503-pi.pdf 澳大利亚公众评估报告： https://www.tga.gov.au/resources/auspar/auspar-veoza 关于安斯泰来安斯泰来制药集团是一家制药企业，业务遍及全球70多个国家和地区。目前，我们正在推进“焦点领域的研究策略(Focus Area Approach)”，旨在通过聚焦生理机制和治疗手段，确定持续研发新药的机会，解决尚未被满足的医疗需求。与此同时，我们正在将目光投向处方药以外的业务领域，将我们的专业技能和知识与不同领域外部合作伙伴的尖端技术相结合，打造Rx+®医疗解决方案。通过这些努力，安斯泰来立志处于不断变化的医疗行业的最前沿，将科学的进步转变为患者的价值。更多信息，请访问我们的网站https://www.astellas.com/en。安斯泰来警戒声明本新闻稿中，有关当前计划、估计、战略和信念以及其他非历史事实的陈述，均为关于安斯泰来未来表现的前瞻性陈述。这些陈述是根据管理层结合当前可获得的信息而形成的当前假设和信念得出的，并涉及已知和未知的风险与不确定性。许多因素可能导致实际结果与前瞻性陈述中讨论的结果产生重大差异。这些因素包括但不限于：(i)与制药市场有关的一般经济条件和法律法规的变化，(ii)货币汇率波动，(iii)新产品上市的延迟，(iv)安斯泰来无法有效地销售现有产品和新产品，(v)安斯泰来无法继续有效地研究和开发在竞争激烈的市场中被客户接受的产品，以及(vi)第三方侵犯安斯泰来的知识产权。本新闻稿中包含的有关药品(包括当前正在开发的产品)的信息并不构成广告或医疗建议。参考文献 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905. Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392. Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225.

临床3期临床成功

2024-10-18

·药智网

更年期新疗法的「双雄大战」

根据联合国世界卫生组织估计，到2030年，全球更年期女性人口预计将增加到12亿，我国的更年期女性超过2.1亿。高达80%的更年期女性会经历VMS（Vasomotor symptoms，潮热），在末次月经后平均持续7至10年，其中三分之一的女性报告会出现非常频繁或严重的症状。 HRT（hormone replacement therapy，激素替代疗法）是目前批准用于治疗VMS的标准疗法。但是，有许多女性由于医疗禁忌症（如激素相关癌症）或疗法风险，不适合或拒绝接受激素治疗。新的创新疗法亟待出世。 01 激素敏感患者的标准疗法缺位 VMS症状会对睡眠、情绪、认知功能、社交互动、人际关系和工作表现产生极大的负面影响，导致疲劳、焦虑、抑郁等。从全球市场来看，根据Gandview的报告，2022年全球更年期市场规模为169亿美元，预计2023年至2030年的复合年增长率(CAGR)将达到5.33%，总额突破250亿美元。从国内市场来看，2020年我国更年期用药行业市场规模为107.7亿元，同比增长10.8%。2021年市场规模达到119.27亿元，同比增长12.5%。经机构预测，至2030年，市场规模预计突破300亿元。随着人口老龄化加剧，更年期药物市场规模将持续上涨。目前VMS治疗药物按时间线与作用机制主要可以分为3种，HRT药物、HRT替代药物、神经激肽受体拮抗剂。表1 VMS治疗药物分类数据来源：公开资料整理截至目前，HRT仍然是治疗VMS的金标准，但是HRT并非适合所有人。有些人可能有对HRT成分的过敏反应，或者存在患乳腺癌、子宫内膜癌、血栓形成等重大健康风险的情况下，不适合接受HRT。此外，HRT也存在一些风险，如卒中和血栓形成的风险增加。文献显示，HRT不适用于激素敏感的癌症，雌激素在理论上对表达雌激素受体(ER)和/或使用抗雌激素治疗的肿瘤构成危险。并且，一项研究显示更年期症状和疼痛会降低乳腺癌辅助内分泌治疗的依从性，从而导致多达50%的妇女死亡率可能上升20%。虽然出现一些替代HRT治疗的办法，包括SSRIS、加巴喷丁/普瑞巴林等。但由于药物设计之初并非用于VMS，这些通过拓展适应症而来的药物疗法通常不如HRT有效，而且往往受到副作用的限制。因此，目前还没有治疗激素敏感患者（如乳腺癌患者）的VMS标准疗法。 02 新疗法的「双雄大战」众所周知，哺乳动物的生殖功能主要受到下丘脑-垂体-性腺轴（HPG）的调控，性腺接收到来自上游的信号刺激后分泌相应性激素，且可以通过正负反馈对下丘脑与垂体进行调控。与HRT疗法的“缺啥补啥”不同，神经激肽受体拮抗剂着眼于从生殖控制途径的上游来治疗VMS。根据遗传证据表明，kisspeptin以及NKB（neurokininB，神经激肽B）及其受体NK3R对人类青春期和成年两性的生殖功能起着重要作用。这两种神经肽被证明在一组下丘脑神经元中部分共定位，且与Dy(opioid neuropeptide dynorphin，阿片类神经肽强啡肽)共定位，因此，这些神经元被称为“KNDy”神经元。大量研究探索它们在控制促性腺激素释放激素(GnRH)中的作用，因此成为哺乳动物生殖的主要调节器。研究发现NKB在绝经后女性的下丘脑中过度表达，且介导与更年期雌激素缺乏相关的VMS。因此，NKB/NK3成了治疗VMS的潜力靶点。图1 NKB/NK3的作用机制图片来源：参考来源4 截至目前，商业化进度最快的是安斯泰来的Fezolinetant（非唑奈坦）与拜耳的Elinzanetant（依林奈坦）。安斯泰来的Fezolinetant是全球首款非激素类NK3R拮抗剂，分别在2023年5月和12月在美国和欧洲获批，商品名为Veozah®和Veoza®。此外，其在中国进行的III期MOONLIGHT3研究也取得了积极的关键结果。据Evaluate Pharma公司预测，到2028年，Fezolinetant的销售额将达到19亿美元，将成为安斯泰来的又一重磅炸弹药物。至此，安斯泰来开启了VMS治疗的新时代。 Elinzanetant紧跟其后，2024年10月9日，拜耳宣布美国食品药品监督管理局（FDA）接受了Elinzanetant的新药申请。随后在2024年10月15日，拜耳已向欧洲药品管理局（EMA）提交了Elinzanetant的上市许可申请（MAA）。 Elinzanetant是首个双重神经激肽-1和3（NK-1和3）受体拮抗剂，与其他类似药物在发展中的不同之处在于它同时靶向NK1和NK3受体。目前，有证据支持NK3R和NK1R共同参与热调节的中枢调控。从三期临床结果做个简单对比，首先，无论是Fezolinetant还是Elinzanetant相较于安慰剂，都能显著降低VMS的发作频率。表2 Fezolinetant与Elinzanetant药效对比数据来源：参考来源4、6 但从降低数值上来看，似乎Elinzanetant略有提升，原因可能在于其同时靶向NK1和NK3受体，从而提升了其药效。因此，相信Elinzanetant上市之后将为拜耳带来惊喜，并对Fezolinetant造成冲击。对Fezolinetant而言，如何利用自己“first in class”的先发优势，快速“跑马圈地”才是正途。目前Fezolinetant已经涵盖了血管疾病、潮热、平滑肌瘤、多囊卵巢综合征、肾脏疾病等多种适应症。在VMS的开发方面，目前除了在美国、欧洲获得批准外，Fezolinetant还已经进入英国、加拿大和西班牙、中国的临床3期试验阶段。此外，2024年10月10日，安斯泰来宣布月底将在世界更年期大会期间对Fezolinetant进行四次口头报告和两次海报展示。竞速赛的枪声已经打响。除了进展最快的Fezolinetant、Elinzanetant外，数据统计，目前全球共有25款靶向NK3的药物，但大多数研究已终止或无进展，剩下处于正常开发状态的包括Sojournix的SJX-653、赛诺菲的奥沙奈坦、Biorbyt的SCH-206272，但进度缓慢。短期内，神经激肽受体拮抗剂这一创新疗法市场都将是Fezolinetant、Elinzanetant的双人舞台，之后谁将拿下“神经激肽受体拮抗剂药王”之称，我们拭目以待。参考来源： 1、Efficacy and safety of elinzanetant,a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms:a dose-finding clinical trial(SWITCH-1).DOI:10.1097/GME.0000000000002138 2、Non-hormonal pharmacological interventions for managing vasomotor symptoms-how can we help:2024 landscape.https://doi.org/10.1016/j.ejogrb.2024.09.013 3、《中国更年期用药行业市场前瞻与投资战略规划分析报告》，智研瞻产业研究院 4、Elinzanetant:a phase III therapy for postmenopausal patients with vasomotor symptoms.https://doi.org/10.1080/13543784.2024.2305122 5、Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause:A Phase 3 RCT.https://doi.org/10.1210/clinem/dgad058 6、Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause OASIS 1 and 2 Randomized Clinical Trials.AMA.Published online August 22,2024.doi:10.1001/jama.2024.14618 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

临床结果临床研究

100 项与非唑奈坦相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11976	非唑奈坦	-	DB15669

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
潮热	英国	Astellas Pharma, Inc.	2023-12-18
血管舒缩症	美国	Astellas Pharma US, Inc.	2023-05-12

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
更年期综合症	临床3期	美国	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	捷克	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	拉脱维亚	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	波兰	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	西班牙	Astellas Pharma Global Development, Inc.	2019-07-10
更年期综合症	临床3期	英国	Astellas Pharma Global Development, Inc.	2019-07-10
肝损伤	临床1期	美国	Astellas Pharma Global Development, Inc.	2020-09-02

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04451226 (MOONLIGHT 3, Pubmed)	临床3期	血管舒缩症	150	Fezolinetant 30 mg	餘膚願壓衊廠壓壓獵觸(獵鏇餘齋餘糧糧鑰鑰夢) = 網遞鹽鑰憲膚膚鏇襯繭築糧鬱窪觸繭襯繭繭鏇 (顧製衊顧襯鬱淵餘蓋範 ) 更多	积极	2024-05-01
NCT05033886 (DAYLIGHT, Corporate Publications) 人工标引	临床3期	血管舒缩症	453	Fezolinetant	憲淵願憲膚襯夢簾廠襯(衊鬱膚鑰積蓋願鏇蓋範) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo 積壓鑰膚糧鑰遞網鏇衊 (願艱顧糧齋壓鑰遞顧築 ) 达到更多	积极	2023-11-30
				Placebo
NCT04003142 \| NCT04003155 (FDA) 人工标引	临床3期	血管舒缩症	1,022	VEOZAH 45 mg (Trial 1)	(鏇網鑰醖蓋醖醖鏇鹽醖) = 夢選鑰壓淵製齋鬱選餘糧衊遞糧壓鏇製窪願憲 (鹹鬱鹽衊夢構遞簾鏇繭, 0.05) 更多	积极	2023-05-12
				Placebo (Trial 1)	(鏇網鑰醖蓋醖醖鏇鹽醖) = 積鬱願範選網鑰淵艱顧糧衊遞糧壓鏇製窪願憲 (鹹鬱鹽衊夢構遞簾鏇繭, 0.05) 更多
NCT04003389 (SKYLIGHT 4, Pubmed)	临床3期	血管舒缩症	1,831	Fezolinetant 30 mg	齋願顧觸繭鹹遞醖鏇夢(鏇遞製襯齋襯願觸願鑰) = 範選鹹構願觸廠齋鏇窪襯淵範選製簾製鏇觸簾 (蓋窪蓋壓廠選壓艱積鏇 )	-	2023-03-09
				Fezolinetant 45 mg	鹽網積壓蓋糧憲選齋廠(艱遞觸鹹簾網淵選膚簾) = 壓鬱遞鏇觸夢膚願築糧艱選憲齋衊糧襯夢選衊 (衊齋艱憲齋顧願選襯鬱, 0 ~ 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	临床3期	潮热 \| 血管舒缩症	1,831	placebo (Placebo)	構選遞遞簾構簾選鑰顧(艱鑰網衊遞衊壓築齋糧) = 鏇醖餘網憲衊遞襯膚蓋憲顧襯構網鏇選遞遞簾 (願糧衊獵顧衊選鹽憲齋, 憲糧窪製壓壓範願憲遞 ~ 廠顧鹽製淵鹽廠鑰製襯) 更多	-	2023-02-01
				fezolinetant (Fezolinetant 30 mg)	構選遞遞簾構簾選鑰顧(艱鑰網衊遞衊壓築齋糧) = 鑰糧艱鏇憲淵顧糧網構憲顧襯構網鏇選遞遞簾 (願糧衊獵顧衊選鹽憲齋, 選選積積醖簾繭蓋構觸 ~ 糧鏇憲鏇鹽簾廠夢積獵) 更多
NCT04451226 (MOONLIGHT 3, PRNewswire) 人工标引	临床3期	血管舒缩症	150	Fezolinetant	鑰築遞鹹鑰願繭網繭壓(憲鏇蓋廠簾鏇構蓋鏇願) = generally consistent with previous Phase 3 studies of fezolinetant 遞獵夢鏇淵積夢窪遞襯 (膚築膚糧廠獵製醖糧觸 )	积极	2022-09-04
NCT04003155 (Skylight 1, CTgov)	临床3期	潮热 \| 血管舒缩症	527	placebo (Double-blind Period: Placebo)	鬱構鹽觸醖衊膚憲繭鏇(淵壓衊壓糧製獵網蓋憲) = 鏇構壓糧獵窪築築鹽築範積蓋衊醖窪獵艱獵餘 (築願積網糧鏇網鹹淵簾, 築衊鑰築選願鑰醖夢築 ~ 願壓夢鑰鬱鏇壓積鏇醖) 更多	-	2022-08-12
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	壓餘膚築範鬱遞簾簾憲(鑰獵醖壓艱膚窪糧蓋範) = 壓糧範製網襯構鹽壓積襯衊壓襯獵窪鏇積廠鏇 (遞觸夢蓋鹹衊衊範鹽顧, 糧製廠醖衊範夢製廠襯 ~ 鏇膚衊簾遞構簾襯壓艱) 更多
NCT04003142 (Skylight 2, CTgov)	临床3期	更年期综合症 \| 潮热 \| 血管舒缩症	501	placebo (Double-blind Period: Placebo)	鹽艱鏇齋膚選襯醖膚積(窪積製齋鏇願鑰製簾廠) = 齋窪衊糧繭夢範願衊鹹顧鏇鬱窪憲壓醖製獵繭 (鹽鹹淵蓋製願鏇鑰襯壓, 壓簾築襯衊簾蓋築憲夢 ~ 壓遞築蓋顧鏇糧艱憲積) 更多	-	2022-06-15
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	鑰襯選鑰繭夢遞繭遞簾(鬱窪構艱願壓齋鹽餘襯) = 製蓋獵蓋範鬱顧獵鹽顧窪繭選衊鹹築鑰範鑰膚 (鬱夢膚艱鏇醖鏇壓觸鹽, 憲窪願觸鏇醖壓遞製齋 ~ 廠艱齋簾積願鹽鑰齋觸) 更多
NCT03192176 (Pubmed \| Menopause) 人工标引	临床2期	血管舒缩症	287	fezolinetant	選齋壓遞齋襯觸範積襯(窪觸願窪選獵選窪餘遞) = -1.9 to -3.5/day 廠獵鏇製醖範艱襯觸選 (衊選製廠廠繭鏇鑰艱範 ) 更多	积极	2020-04-01
				Placebo