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2024-12-01

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

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100 项与非唑奈坦相关的转化医学

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100 项与非唑奈坦相关的专利（医药）

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项与非唑奈坦相关的文献（医药）

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.

2024-09-21·EXPERT OPINION ON PHARMACOTHERAPY

Reply to ‘fezolinetant: a novel nonhormonal therapy for vasomotor symptoms due to menopause requiring careful evaluation of the benefit-risk balance’

Letter

作者: Andrus, Miranda R. ; Roberts, Megan Z.

2024-08-01·BJOG : an international journal of obstetrics and gynaecology

Fezolinetant impact on health‐related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials

Article

作者: Santoro, Nanette ; Cano, Antonio ; Stute, Petra ; English, Marci L. ; Scrine, Ludmila ; Blogg, Martin ; Nappi, Rossella E. ; Morga, Antonia ; Ottery, Faith D. ; Siddiqui, Emad

Abstract:

Objective:

To assess the effect of fezolinetant treatment on health‐related quality of life using pooled data from SKYLIGHT 1 and 2 studies.

Design:

Prespecified pooled analysis.

Setting:

USA, Canada, Europe; 2019–2021.

Population:

1022 women aged ≥40 to ≤65 years with moderate‐to‐severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS.

Methods:

Women were randomised to 12‐week double‐blind treatment with once‐daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40‐week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re‐randomised to fezolinetant received 30 or 45 mg).

Main outcome measures:

Mean changes from baseline to weeks 4 and 12 on Menopause‐Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI‐VMS) domain scores, Patient Global Impression of Change in VMS (PGI‐C VMS); percentages achieving PGI‐C VMS of ‘much better’ (PGI‐C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance.

Results:

Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was −0.57 (95% confidence interval [CI] −0.75 to −0.39) at week 4 and −0.47 (95% CI −0.66 to −0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI‐VMS scores improved. Twice as many women receiving fezolinetant reported VMS were ‘much better’ than placebo based on PGI‐C VMS assessment.

Conclusions:

Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI‐VMS. A high proportion receiving fezolinetant felt VMS were ‘much better’ based on PGI‐C VMS responder analysis.

158

项与非唑奈坦相关的新闻（医药）

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

2024-10-10

·PRNewswire

Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause

TOKYO, Oct. 10, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that VEOZA™ (fezolinetant)*, its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Marci English, Vice President, Head of BioPharma Development, Astellas "Astellas is committed to advancing innovative science, and the data at the World Congress on Menopause further our understanding of how VMS impacts individuals and women's preferences for treatment. In addition, we are excited to share trial design for our recently initiated HIGHLIGHT study assessing fezolinetant for the treatment of moderate to severe VMS in patients with breast cancer taking adjuvant endocrine therapy." Emad Siddiqui, M.D., Vice President, Head of Specialty Therapeutic Area for Medical Affairs, Astellas "We are dedicated to continuing to expand the knowledge about fezolinetant beyond the pivotal trials. Our presentations at the World Congress on Menopause encompass a broad range of clinical and health-related quality of life analyses that further highlight the safety and efficacy of fezolinetant, as well as its positive impact on patient-reported outcomes including sleep and productivity at work." Fezolinetant data will be featured in four oral and two poster presentations: Two oral presentations from the SKYLIGHT 1 and 2 studies focus on patient-reported sleep outcomes and impact on work productivity with fezolinetant (Menopause New Treatments 1 and 2; Monday, Oct. 21, 3:50-5:20 p.m.; A. Cano and R. Nappi, respectively). Two oral presentations from the DAYLIGHT study highlight response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy (Menopause New Treatments 1; Monday, Oct. 21, 3:50-5:20 p.m.; A. Hirschberg and M. Shapiro, respectively). Poster highlights analyses of clinical and nonclinical data demonstrating no association between fezolinetant treatment and incidence of malignant neoplasm (P073; Sunday, Oct. 20, 7:40-9 p.m.; M. Shapiro). Poster reviews study design for the recently initiated HIGHLIGHT 1 phase 3 clinical study designed to evaluate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer receiving adjuvant endocrine therapy (P055; Sunday, Oct. 20, 7:40-9 p.m.; P. Briggs). Two additional oral presentations highlight Australian women's preferences for treatment of VMS associated with menopause and results of a literature review designed to identify and characterize concepts relevant to individuals' experiences of VMS with a goal of informing the development of a culturally sensitive self-assessment tool for VMS. *VEOZA: Approved as "VEOZAH ™" in U.S. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 menopausal women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 menopausal women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About DAYLIGHT DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy. A total of 453 women were enrolled at 69 sites in Canada, Europe and Turkey. About HIGHLIGHT 1™ HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites in Europe and Canada. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks. About VEOZA™ (fezolinetant) VEOZA (fezolinetant) is a nonhormonal neurokinin 3 (NK3) receptor antagonist indicated in Australia for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. VEOZA works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.3,4,5 Important Safety Information The full Australian Product Information and Australian Public Assessment Report (AusPAR) for fezolinetant is available from the Australian Government Therapeutic Goods Administration. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. 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. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes 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. 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. 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. References 1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. 3 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. 4 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. 5 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. SOURCE Astellas Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期上市批准

100 项与非唑奈坦相关的药物交易

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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,

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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,

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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

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临床结果

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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	夢鬱淵齋鑰淵鏇積簾壓(衊遞遞鏇壓廠遞觸築鹽) = 衊鬱衊襯窪鹽繭襯蓋憲願製淵壓鏇衊製鬱膚憲 (構窪構簾繭淵鹽艱憲鑰 ) 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	範獵網觸鬱餘鏇壓廠製(膚顧餘膚範構選醖鏇膚) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo 糧簾廠廠醖蓋鑰願齋衊 (鏇鹽鏇淵窪簾蓋醖築繭 ) 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)	(積廠願簾壓獵齋遞夢廠) = 鏇繭鬱衊鑰蓋繭製衊艱鹹製鑰獵積製糧蓋鑰壓 (遞窪顧網構壓製衊選夢, 0.05) 更多	积极	2023-05-12
				Placebo (Trial 1)	(積廠願簾壓獵齋遞夢廠) = 範築淵鹽蓋糧獵齋製膚鹹製鑰獵積製糧蓋鑰壓 (遞窪顧網構壓製衊選夢, 0.05) 更多
NCT04003389 (SKYLIGHT 4, Pubmed)	临床3期	绝经期综合征	1,831	Fezolinetant 30 mg	窪網鹽鹽範鏇積糧醖壓(網蓋積衊範鏇鏇餘積糧) = 襯廠觸範淵廠築製襯鑰選簾積艱鹹餘繭範繭繭 (構醖鑰顧鹽壓觸醖鏇憲 )	-	2023-03-09
				Fezolinetant 45 mg	鏇鹹壓壓鏇顧範積網醖(繭鑰簾鹽築衊衊選憲鹹) = 願鑰鏇糧顧繭築夢鬱繭壓齋遞壓壓簾窪築齋鹹 (醖艱鹹廠觸鑰膚襯積繭, 0 ~ 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	临床3期	血管舒缩症 \| 潮热	1,831	placebo (Placebo)	網鹽鏇憲遞鬱蓋範顧衊(夢築範鹹鹽夢壓顧鬱淵) = 衊餘糧簾築簾窪衊窪壓鹽選觸願糧糧襯遞餘築 (蓋淵襯齋淵憲簾艱鬱選, 廠網選鏇衊衊廠蓋鹹鬱 ~ 憲襯蓋鏇獵夢壓築餘製) 更多	-	2023-02-01
				fezolinetant (Fezolinetant 30 mg)	網鹽鏇憲遞鬱蓋範顧衊(夢築範鹹鹽夢壓顧鬱淵) = 夢鏇壓淵壓餘積積積選鹽選觸願糧糧襯遞餘築 (蓋淵襯齋淵憲簾艱鬱選, 顧遞製製鹹範鏇糧膚齋 ~ 願廠選蓋廠衊糧遞簾鹽) 更多
NCT04451226 (MOONLIGHT 3, PRNewswire) 人工标引	临床3期	血管舒缩症	150	Fezolinetant	顧壓糧齋壓繭齋鹽廠鹽(壓製蓋製鏇夢鏇構衊繭) = generally consistent with previous Phase 3 studies of fezolinetant 製簾獵壓齋鏇艱網繭夢 (艱鏇鏇憲齋夢膚艱獵夢 )	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)	齋獵鏇夢繭顧鹽構淵鹽(憲選鏇觸獵襯醖糧網獵) = 獵鏇餘淵憲積蓋範壓夢顧範簾願築壓遞繭鏇齋 (積範壓鑰廠選製製鏇餘, 觸壓範顧觸鹽鏇築淵醖 ~ 淵夢糧願膚壓鬱艱鹹繭) 更多	-	2022-08-12
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	夢廠願網廠構齋鏇遞鹽(選鬱襯襯顧製遞壓網壓) = 鬱製糧醖獵艱廠膚選醖衊衊願襯簾餘窪網夢製 (膚夢壓醖淵衊繭簾鏇襯, 夢齋襯鏇顧壓淵艱獵夢 ~ 蓋壓遞壓簾獵願憲膚網) 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)	醖襯獵積壓鬱壓獵壓範(範積築糧廠壓築網齋構) = 鬱繭憲淵築鹹窪鏇淵繭餘遞膚構鏇餘憲憲餘築 (齋壓製醖積觸憲獵鏇觸, 餘蓋鹹鑰艱窪鹹簾廠範 ~ 壓艱鏇遞醖蓋簾壓積繭) 更多	-	2022-06-15
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	壓醖醖衊範簾鬱選糧鏇(構糧鑰積簾鏇鑰憲淵鹹) = 鬱築觸膚廠齋憲範遞選觸築夢餘鹹糧觸糧範鹽 (簾選簾願餘蓋淵構膚鹹, 網鏇鬱鬱襯鬱廠餘衊淵 ~ 鑰襯艱壓遞鬱範築選艱) 更多
NCT03192176 (Pubmed \| Menopause) 人工标引	临床2期	血管舒缩症	287	fezolinetant	築淵簾鹽繭繭繭願襯襯(顧範夢遞醖繭願衊鹹觸) = -1.9 to -3.5/day 鬱選簾齋網艱淵製觸窪 (簾製壓鏇繭鹹鏇餘鏇製 ) 更多	积极	2020-04-01
				Placebo