拜耳Lynkuet™在美国获批治疗因更年期引起的中度至重度血管舒缩症状-动脉网

Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause

拜耳等信源发布 2025-10-24 01:29

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October

十月

2025

19:25 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause

拜耳的Lynkuet™（elinzanetant）在美国获批用于治疗更年期引起的中度至重度血管舒缩症状。

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

This approval is supported by data from the Phase III OASIS clinical program evaluating Lynkuet™ (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes), due to menopause

这项批准得到了三期OASIS临床项目的数据支持，该项目评估了Lynkuet™（elinanetant）用于治疗中度至重度血管舒缩症状（VMS，也称为潮热），这些症状是由绝经引起的。

/ In OASIS 1 and 2, elinzanetant met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline

在OASIS 1和2中，elinzanetant在第4周和第12周达到了减少中度至重度潮热次数和严重程度的主要终点。

/ Hot flashes are a common symptom of menopause

/ 潮热是更年期的常见症状

and one of the main reasons women seek treatment

女性寻求治疗的主要原因之一

, hot flashes may impact women differently

，潮热对女性的影响可能有所不同

and some can be disruptive

有些可能会造成破坏

/ Elinzanetant is the first dual neurokinin (NK) targeted therapy,

/Elinzanetant 是第一个双重神经激肽（NK）靶向疗法，

NK1 and NK3 receptor antagonist

NK1和NK3受体拮抗剂

Berlin, October 24, 2025

柏林，2025年10月24日

–

Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved elinzanetant as the first dual neurokinin (NK) targeted therapy

拜耳今天宣布，美国食品和药物管理局 (FDA) 已批准 elinzanetant 作为首个双重神经激肽 (NK) 靶向疗法。

, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, under the brand name Lynkuet™ for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) due to menopause. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons with elinzanetant can modulate neuronal activity in the thermoregulation associated with hot flashes..

，神经激肽1（NK1）和神经激肽3（NK3）受体拮抗剂，品牌名为Lynkuet™，用于治疗由更年期引起的中度至重度血管舒缩症状（VMS，也称为潮热）。通过抑制KNDy（吻素/神经激肽B/强啡肽）神经元上的NK1和NK3受体信号，elinzanetant可阻止P物质和神经激肽B的作用，从而调节与潮热相关的体温调节神经活动。

The FDA approval is supported by data from three Phase III clinical studies (OASIS 1, OASIS 2 and OASIS 3) that evaluated the efficacy and safety of elinzanetant for the treatment of moderate to severe VMS due to menopause.

FDA 的批准得到了三项 III 期临床研究（OASIS 1、OASIS 2 和 OASIS 3）的数据支持，这些研究评估了 elinzanetant 治疗由更年期引起的中度至重度 VMS 的有效性和安全性。

“For more than a century, Bayer has been dedicated to pioneering advances in women’s health, and this FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

“一个多世纪以来，拜耳一直致力于推动女性健康领域的进步，此次FDA的批准代表了我们迈出的重要一步——这是我们首个用于缓解更年期血管舒缩症状的无激素治疗方案。”拜耳制药执行副总裁、全球产品战略与商业化负责人及制药领导团队成员克里斯汀·罗斯表示。

“There is a need for more individualized approaches to menopause care, and Lynkuet™ addresses a significant gap in treatment options. The approval in the U.S. reflects our unwavering commitment to delivering science-driven solutions that meet women’s evolving healthcare needs and empower them to take charge of their health at every stage of life.”.

“更个性化的绝经护理方法存在需求，而Lynkuet™填补了治疗选择中的重要空白。在美国的获批反映了我们始终致力于提供科学驱动的解决方案，满足女性不断变化的医疗需求，并赋能她们在生命每个阶段掌控自己的健康。”

The efficacy of elinzanetant for the treatment of moderate to severe VMS due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women.

在两项随机、双盲、安慰剂对照、多中心临床试验 OASIS 1 和 OASIS 2 中，796 名绝经妇女的前 12 周内，elinzanetant 治疗中度至重度 VMS（更年期相关症状）的疗效得到了证实。

The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe VMS from baselines to weeks 4 and 12, including day and night hot flashes.

两项试验中的共同主要疗效终点是从基线到第4周和第12周，中度至重度VMS（血管舒缩症状）的频率和严重程度的平均变化，包括日间和夜间潮热。

The safety of elinzanetant was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2 and OASIS 3) in 1420 women. In OASIS 3, 627 women received elinzanetant or placebo for up to 52 weeks to evaluate long-term safety.

elinzanetant 的安全性在三项随机、双盲、安慰剂对照、多中心临床试验（OASIS 1、OASIS 2 和 OASIS 3）中对 1420 名女性进行了评估。在 OASIS 3 中，627 名女性接受了长达 52 周的 elinzanetant 或安慰剂治疗，以评估其长期安全性。

“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.” .

“这三项研究调查了elinzanetant治疗由更年期引起的中度至重度潮热的安全性和有效性，”UVA健康中心的教授兼中年健康主任、OASIS 2试验的首席研究员JoAnn Pinkerton博士说道。“潮热，尤其是严重时，可能会影响女性的日常生活，而这一批准为医疗保健提供者提供了一种新的治疗选择，可以作为中度至重度更年期潮热的一线治疗。”

Hot flashes are a common symptom of menopause

潮热是更年期的常见症状。

that may impact women differently

可能对女性产生不同影响的

. Hot flashes can be disruptive

潮热可能会造成困扰

and are a common reason for which women in menopause seek treatment

是更年期女性寻求治疗的常见原因

。

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” said Claire Gill, President and Founder of the National Menopause Foundation.

“重要的是，女性要知道她们有选择可以治疗由更年期引起的中度至重度潮热，而今天的批准进一步扩宽了女性治疗这些症状的选择，”全国更年期基金会主席兼创始人克莱尔·吉尔表示。

Elinzanetant is expected to be available in the U.S. beginning in November 2025.

Elinzanetant 预计将于 2025 年 11 月开始在美国上市。

About elinzanetant

关于elinzanetant

Elinzanetant is the first dual neurokinin (NK) targeted therapy,

Elinzanetant 是首个双重神经激肽（NK）靶向疗法，

neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, approved in the U.S. for the treatment of moderate to severe VMS due to menopause.

神经激肽1（NK1）和神经激肽3（NK3）受体拮抗剂，获美国批准用于治疗因绝经引起的中度至重度血管舒缩症状（VMS）。

The compound is being developed globally for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation.

该化合物正在全球范围内开发，用于治疗与更年期或乳腺癌内分泌治疗（ET）相关的中度至重度血管舒缩症状（VMS；也称为潮热），每日口服一次。越来越多的证据表明，称为吻素、神经激肽B和强啡肽（KNDy）的下丘脑神经元，表达NK-1和NK-3受体及其配体P物质和NKB，在体温调节中起作用。

Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbance..

由于自然绝经或内分泌治疗导致的雌激素活性下降会引起KNDy神经元的过度活跃和体温调节中枢的失调，从而引发血管舒缩症状（VMS）。NK-1受体也可能通过出汗和外周血管扩张参与散热反应，并对睡眠障碍产生影响。

Elinzanetant has been approved under the brand name Lynkuet™ in the U.S. as well as in Australia, Canada, the UK, and Switzerland. It is pending approval in the European Union and under review in other markets around the world.

Elinzanetant 已在美国、澳大利亚、加拿大、英国和瑞士以品牌名 Lynkuet™ 获得批准。它在欧盟的审批仍在进行中，并且正在全球其他市场接受审查。

About Menopause

关于更年期

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s.

到2030年，全球经历更年期的女性人口预计将增加到12亿，每年有4700万女性进入这一阶段。更年期是女性生命中的一个阶段，与卵巢功能的逐渐衰退有关，通常发生在女性的40多岁或50岁出头。

Menopause symptoms can also be a consequence of surgical (such as bilateral oophorectomy) or medical treatment (such as endocrine therapy for breast cancer). The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes..

更年期症状也可能是手术（如双侧卵巢切除术）或药物治疗（如乳腺癌的内分泌治疗）的结果。在更年期过渡期间，最常报告且影响最大的症状是血管舒缩症状（VMS）、睡眠障碍和情绪变化。

6-8

Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

解决这些症状是保持绝经期女性的功能能力和生活质量的关键，这在医疗保健和社会经济方面都具有高度相关性。

About Women’s Healthcare at Bayer

关于拜耳的女性医疗保健

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases.

女性健康深植于拜耳的DNA中。作为女性医疗保健领域的全球领导者，拜耳长期致力于通过推进一系列创新治疗方案来实现科学改善生活的目标。拜耳提供多种有效的短效和长效避孕方法，以及用于更年期管理和妇科疾病的治疗方案。

Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives.

拜耳还在关注创新方案，以应对全球女性未被满足的医疗需求，并拓宽如更年期等方面的治疗选择。此外，拜耳计划到2030年，通过资助多利益相关方的援助项目来加强能力建设，并确保提供价格合理的现代避孕药具，从而使低收入和中等收入国家每年1亿女性获得计划生育服务。

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations..

这是自2020年以来全面可持续发展措施和承诺的一部分，并与联合国的可持续发展目标相一致。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用总计达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

查找更多信息，请访问

https://pharma.bayer.com/

在Facebook上关注我们：

http://www.facebook.com/bayer

在LinkedIn上关注我们：

Bayer | Pharmaceuticals

拜耳 | 制药

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司实际未来结果、财务状况、发展或业绩与这里给出的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，这些报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任 whatsoever

them to future events or developments.

他们对未来事件或发展。

References:

参考文献：

LYNKUET

领克

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（elinzanetant）[处方信息]。新泽西州惠帕尼：拜耳医疗保健制药公司；2025年10月

Thurston, R. C., & Joffe, H. (2011). Vasomotor symptoms and menopause: Findings from the Study of Women's Health across the Nation.

瑟斯顿，R.C.，& 乔菲，H.（2011）。《全国女性健康研究中的血管舒缩症状与更年期的发现》。

Obstetrics and Gynecology Clinics of North America, 38

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(3), 489–501.

(3), 489–501。

https://doi.org/10.1016/j.ogc.2011.05.006

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Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment.

克罗嫩贝格 F. 更年期潮热：生理学及生物社会文化视角下的评估方法综述。

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Shepherd JA、Shiozawa A、Schild AL、Singh D、Mancuso SA。回顾性文本和定性分析绝经引起的血管舒缩症状的患者体验与管理：来自PatientsLikeMe社区的声音。《更年期》。2024年9月1日；31(9):789-795。doi: 10.1097/GME.0000000000002391。电子版发布于2024年7月8日。

PMID: 38980735; PMCID: PMC11469626..

PMID: 38980735; PMCID: PMC11469626。

US Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy. FDA.

美国食品药品监督管理局。用于治疗血管舒缩症状、外阴和阴道萎缩的雌激素及雌激素/孕激素药物产品。FDA。

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/雌激素和雌激素孕激素药物产品用于治疗血管舒缩症状以及外阴和阴道萎缩

. Accessed October 23, 2025.

。访问日期：2025年10月23日。

Thurston & Joffe, Obstet Gynecol Clin North Am. 2011 September ; 38(3): 489–501.

瑟斯顿和乔菲，《北美妇产科诊所》。2011年9月；38（3）：489-501。

Thurston, Climacteric 2018 April; 21(2): 96-100 6. Thurston RC et al, Sleep. 2019;42(9)

瑟斯顿，《更年期》2018年4月；21(2): 96-100 6. 瑟斯顿 R.C. 等，《睡眠》。2019年；42(9)

.Utian, W.H. Health Qual Life Outcomes 3, 47 (2005)

Utian, W.H. 健康质量生活成果 3，47（2005）

Contacts

联系人

Katja Wiggers