A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants

This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.

开始日期2026-07-22

申办/合作机构

Bayer AG

NCT07077395

/ Recruiting临床2期IIT

Finding Links Between Hot flASHes and CardioVascular Disease

The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?

开始日期2026-03-01

申办/合作机构

The Massachusetts General Hospital

100 项与依林扎奈坦相关的临床结果

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100 项与依林扎奈坦相关的专利（医药）

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项与依林扎奈坦相关的文献（医药）

2026-10-01·ANNALS OF PHARMACOTHERAPY

Elinzanetant: A Novel Approach to Management of Vasomotor Menopausal Symptoms

Review

作者: Barnes, Kylie N. ; Rowe, Jordan M. ; Coffman, Ian

Objective::

To review the efficacy and safety of elinzanetant for the management of vasomotor symptoms (VMS) associated with menopause.

Data Sources::

Literature was identified using PubMed (1966 to January 2026), EMBASE (1973 to January 2026), and clinicaltrials.gov. Search terms included elinzanetant, VMS, and menopause, limiting trials to those published in English.

Study Selection and Data Extraction::

Articles selected for inclusion included trials evaluating elinzanetant for the treatment of VMS.

Data Synthesis::

Elinzanetant was evaluated for reduction in frequency and severity of moderate-to-severe VMS associated with menopause in 3 phase 3 trials (OASIS 1, 2, and 3) and 1 phase 3 trial in patients receiving endocrine therapy for breast cancer (OASIS 4). All studies showed significant improvements in symptom frequency at week 12 compared to placebo ( P < .001). Improvement in sleep disturbances and quality of life was also significant in OASIS 1, 2, and 4. Elinzanetant was well-tolerated, with headache, fatigue, dizziness, somnolence, abdominal pain, and rash reported as the most frequent drug-associated adverse effects.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

Elinzanetant is the first dual neurokinin-1 and neurokinin-3 receptor antagonist approved for moderate-to-severe VMS associated with menopause. Elinzanetant offers a nonhormonal treatment option with favorable tolerability, representing a promising alternative for patients who cannot or prefer not to use hormonal therapy.

Conclusion::

The U.S. Food and Drug Administration approval of elinzanetant provides an additional nonhormonal option for managing moderate-to-severe VMS of menopause in patients for whom hormonal therapy is contraindicated or undesired.

2026-09-01·MATURITAS

Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program

Review

作者: Soares, Claudio N ; Donders, Gilbert ; Simon, James A ; Nappi, Rossella E ; Haberland, Claudia ; Caetano, Cecilia ; Pinkerton, JoAnn V ; Zuurman, Lineke ; Cardoso, Fatima ; Laapas, Kaisa ; Panay, Nick ; Maki, Pauline ; Brennan, Donal J

Elinzanetant, a dual neurokinin-1/-3 receptor antagonist, is approved for the treatment of moderate-to-severe vasomotor symptoms. The double-blind, randomized, placebo-controlled Phase III OASIS-1-4 studies evaluated elinzanetant's efficacy and safety in diverse populations of women, including those with vasomotor symptoms associated with natural or surgical menopause (OASIS-1, -2, and -3) and caused by endocrine therapy for breast cancer (OASIS-4). Results were similar across all trials for the respective primary and key secondary endpoints (included in the statistical testing hierarchy). Significant reductions vs. placebo in the frequency of vasomotor symptoms appeared from as early as week 1 in OASIS-1 and -2 (analyzed descriptively in OASIS-3 and -4), and at week 4 in OASIS-1, -2, and -4 (analyzed descriptively in OASIS-3). By week 12, all studies showed significant reductions vs. placebo, with benefits maintained for up to 50 weeks. In OASIS-1 and -2, the severity of vasomotor symptoms significantly decreased vs. placebo at weeks 4 and 12 (analyzed descriptively in OASIS-3 and -4). Elinzanetant treatment improved sleep disturbance, assessed by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T-score, and menopause-related quality of life, measured as total score on the Menopause-specific Quality of Life questionnaire, across all four trials as early as week 1. Significant reductions vs. placebo were seen at week 12 in OASIS-1, -2, and -4 (key secondary endpoints; analyzed descriptively in OASIS-3 as a secondary endpoint). Elinzanetant was generally well tolerated with consistent efficacy across all OASIS trials in diverse populations of women experiencing vasomotor symptoms.

2026-08-01·DRUG SAFETY

Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant

Review

作者: Andrade, Raúl J ; Larrey, Dominique ; Trajanovic, Mila ; Horsmans, Yves ; Anderson, Richard A ; Zuurman, Lineke ; Groettrup-Wolfers, Esther ; Lewis, James H

BACKGROUND:

Elinzanetant is a selective dual neurokinin (NK)-1/-3 receptor antagonist for the treatment of moderate-to-severe vasomotor symptoms associated with menopause or caused by endocrine therapy. Elinzanetant has been approved by health authorities in several countries. The occurrence of elevated liver enzymes has been observed in clinical use with NK-3 receptor antagonists, e.g., fezolinetant and pavinetant, with recommendations for liver monitoring in the fezolinetant labeling information. Therefore, a thorough evaluation of the liver safety data from clinical trials with elinzanetant was undertaken.

OBJECTIVE:

To summarize available hepatic safety data from the clinical development program of elinzanetant.

METHODS:

The potential risk of drug-induced liver injury (DILI) associated with elinzanetant was evaluated on the basis of the analysis of 24 phase 1 studies, three phase 2 studies (RELENT-1, SWITCH-1, NIRVANA), and four randomized, placebo-controlled phase 3 studies (OASIS 1‒4). Liver safety assessments were conducted throughout the studies as per protocol. In the phase 3 studies, a liver safety monitoring board (LSMB) performed an independent and blinded review of cases meeting close liver observation criteria, in alignment with US Food and Drug Administration DILI Guidance and the Council for International Organizations of Medical Sciences 2020 consensus on DILI. An independent data and safety monitoring board monitored the general safety of the participants.

RESULTS:

In the clinical program (phases 1‒3), there was no imbalance between the elinzanetant and placebo groups in alanine aminotransferase (ALT) elevations up to 5×, 10×, or 20× the upper limit of normal (ULN). In the pooled studies that included postmenopausal women, during weeks 1‒52 of treatment, ALT or aspartate transaminase (AST) elevations ≥ 3× ULN were observed in 1.2% of participants treated with elinzanetant 120 mg and in 1.0% of participants treated with placebo. In addition, there were no cases meeting Hy's law, and no indication of cholestatic injury. The LSMB assessed two cases on elinzanetant (2 out of 1697 participants, 0.12%) and one case on placebo (1 out of 1028, 0.10%) as probably related to study drug. For the cases on elinzanetant, one participant had a peak ALT level 7.4× ULN and the other had a peak ALT 3.5× ULN. Alkaline phosphatase and total bilirubin levels remained within reference range; both cases were mild and reversible. The peak ALT for the participant on placebo was 3.6× ULN. No case was classified as highly likely or definite.

CONCLUSIONS:

The aggregated phase 1‒3 clinical data, supported by preclinical toxicology and individual case adjudications of participants with elevated liver enzymes, suggest that there is a low risk of liver toxicity for elinzanetant. On the basis of these data, liver test monitoring was considered unnecessary in clinical practice by the LSMB (video abstract available online). Supplementary file2 (MP4 73923 KB).

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项与依林扎奈坦相关的新闻（医药）

2026-10-04

·肖生客

【肖生客】9月28日到10月4日创新药周报

作者：刘肖各国监管政策：FDA审批、补充申请与临床规则变化 1️⃣ Vanda为Hetlioz寻求新适应症扩展，FDA时差听证会临近。Vanda制药在FDA就Hetlioz治疗时差障碍举行听证会前，为该药物布局新的扩展适应症。Hetlioz已获批用于非24小时睡眠觉醒障碍，若时差适应症获批将扩大患者群体，但FDA听证结果将直接影响该商业拓展前景。 2️⃣ HLB胆管癌之后拟下月重新提交肝癌新药FDA申请。韩国HLB在胆管癌项目之后，预计下月重新向FDA提交肝癌新药申请。此前受挫后重启申报，若获批将影响肝癌靶向治疗竞争格局，也是韩国创新药出海的关键一役。 3️⃣ 2026年第四季度值得关注的5项FDA审批决定。BioPharma Dive盘点2026年第四季度5项值得关注的FDA审批决定。这些决定涉及多个治疗领域的药物上市前景，将影响相关企业的商业化节奏与投资者预期。 4️⃣ FDA对leniolisib补充申请授予优先审评，针对低体重APDS患儿。FDA对leniolisib补充新药申请授予优先审评，用于治疗低体重APDS儿童患者。若通过，将扩大该PI3Kδ抑制剂的适用人群，利好罕见免疫缺陷病赛道。 5️⃣ FDA对elinzanetant授予优先审评，用于乳腺癌内分泌治疗女性VMS。FDA对elinzanetant授予优先审评，用于接受内分泌治疗的乳腺癌女性血管舒缩症状。该非激素疗法若获批，将为乳腺癌患者潮热管理提供新选择。突破性科学进展：体内CAR-T、AI研发与科研诚信 1️⃣ 体内CAR-T可解决递送难题，实体瘤仍需更多突破。pharmaphorum报道指出，体内CAR-T有望解决传统CAR-T的体外制备与递送瓶颈，但实体瘤治疗仍面临肿瘤微环境、靶点选择等挑战。 2️⃣ Zealand Pharma在麻省剑桥开设新研究中心。BioSpace报道，Zealand Pharma在美国马萨诸塞州剑桥市开设新研究中心。此举有助于贴近美国生物医药研发集群，吸引人才并推进代谢及肽类药物管线。 3️⃣ BioDuro任命Greg Makara为发现化学高级副总裁。Contract Pharma报道，BioDuro任命Greg Makara负责发现化学业务，反映CRO/CDMO企业持续加码早期药物发现平台。 4️⃣ Nature综述CAR-T细胞疗法在非肿瘤疾病中的应用。综述系统梳理CAR-T在自身免疫病等非肿瘤方向的研究进展，说明CAR-T正在从单一抗癌工具向免疫调控平台延伸。 5️⃣ Genencell创始人将就药物试验数据欺诈案面临上诉裁决。临床试验数据造假直接冲击药物审批可信度。案件进展对韩国及全球生物医药行业的合规底线具有警示意义。一周获批的药物与器械：罕见病、肾癌与肺癌治疗 1️⃣ Camzyos获批用于青少年梗阻性HCM。该药此前已获批用于成人，适应症下延至青少年，为这一罕见心脏疾病提供了新的药物选择。 2️⃣ Belzutifan联合乐伐替尼获批晚期ccRCC。该联合方案为晚期透明细胞肾细胞癌患者提供了新的治疗组合，可能改变靶向治疗与免疫治疗的临床决策路径。 3️⃣ PhRMA任命新CEO；Pierre Fabre第三次冲刺Ebvallo获批。PhRMA换帅将影响美国药企政策游说方向，而Ebvallo多次冲刺反映细胞疗法审批仍存挑战。 4️⃣ 阿斯利康联合和黄医药肺癌药物组合在美申报上市。路透社报道，阿斯利康已向美国FDA提交与和黄医药联合开发的肺癌药物组合上市申请。若获批，将强化阿斯利康在肺癌靶向治疗领域的地位，也是和黄医药创新药出海美国的关键一步。企业合作与BD交易：CDMO扩产与研发服务整合 1️⃣ ESTEVE CDMO追加1750万美元投资伊利诺伊基地。投资将用于扩大产能，反映欧美CDMO需求持续，区域化产能布局正成为承接回流订单与保障供应链韧性的关键动作。 2️⃣ Serán Bioscience获增长投资。Contract Pharma报道，Serán Bioscience获得增长型投资，用于推进制剂与生物技术服务平台，差异化制剂能力仍是资本关注的方向。 3️⃣ ai3Bio由两家生物技术公司合并成立，探索免疫重置。新公司聚焦免疫重置及差异化技术路径，反映自免及免疫相关疾病赛道仍在吸引资源整合。 4️⃣ Natco Pharma对eGenesis投资增至1670万美元。印度Natco Pharma加码异种移植公司eGenesis，显示印度药企正关注基因编辑与器官移植前沿赛道。 5️⃣ Novotech收购Agilex Biolabs。此次收购将扩展Novotech在生物分析领域的服务能力，反映CRO行业通过并购提升一体化服务能力的趋势。一周观察本周信息集中在四个方向：FDA审批与补充申请继续影响企业商业化节奏；体内CAR-T和非肿瘤CAR-T拓展了细胞治疗的技术边界；CDMO与CRO通过扩产和并购增强一体化能力；中国创新药出海则越来越依赖本地临床、注册与供应链协同。对国内企业来说，出海不只是把药物带到海外，更要提前准备与目标市场相匹配的临床证据、生产能力、注册策略和合作网络。 #创新药见闻 #创新药出海 #基因治疗 #CGT #生物医药 #CDMO

2026-09-30

·中国妇产科网

国际关注丨女性更年期用药革命性突破

诸多顽固的障碍仍在阻碍针对一系列女性更年期症状的药物研发。近年来，更年期话题已走出阴影，进入公众视野。人们越来越愿意谈论潮热和盗汗等问题，而一批承诺能缓解多种症状的远程医疗初创企业如雨后春笋般涌现，催生出价值高达170 亿美元的更年期用药市场[1-2]。但治疗需求仍远非科学进展可及，根深蒂固的结构性障碍正困扰着女性健康领域。安永全球及美洲健康业务负责人Kim Dalla Torre 表示，人们已挺身而出，正试图在特定领域产生影响。在研究方面，女性健康领域历来投入不足[3]。据世界经济论坛称，即使在今天，私营医疗资金中仅约6%用于女性健康，这阻碍了创新[4]。Dalla Torre 指出，女性在临床研究中的代表性仍然不足[5]，而医生在制定治疗决策时，也因证据基础有限而束手束脚。各类药企纷纷介入，力图填补这一空白。尽管一些主流医疗保健机构已扩大了针对更年期的护理选择[6]，但也有大量小型企业涌入该领域，销售未经证实的保健食品和产品，这些产品占据了更年期市场支出的绝大部分[7]。近期发表在《英国医学杂志》（BMJ）上的一篇文章，对昂贵的激素检测套餐日益普及表示担忧，包括美国妇产科医师学会在内的多个医学协会都认为这种检测毫无必要[8]。这些检测费用高达数百美元，但临床价值有限，原因在于激素治疗并没有明确的时间窗口。尽管如此，这些毫无必要的检测却被用来为那些未经有效性和安全性验证的个体化激素治疗方案提供依据。研究者指出，这一现象反映了女性健康领域商业化带来的更广泛问题，也标志着该领域正逐渐偏离循证医学规范。在制药行业缺乏研发投入的情况下，可能仍将是该领域未来面临的一大挑战。对于很多制药公司，更年期用药研发一直坎坷，部分原因在于症状的异质性。据估计，全美每天约有6000 名女性进入更年期，但她们的体验各不相同[9]。有些人会出现潮热和盗汗等令人衰弱的血管运动症状，而另一些人则表现为脑雾和睡眠障碍。“目前没有一种疾病值得企业投入资金，并断言‘这就是我在女性健康领域能获得投资回报的地方’……没有一种药物能够解决这个问题，”Dalla Torre 表示。激素替代疗法（HRT）仍是医生用于缓解症状的主要治疗手段之一，在一度失宠后，又重新兴起。20 世纪90 年代，HRT 曾被广泛誉为解决更年期诸多问题的良方。但这一局面在2002 年急转直下，当时研究者因担忧HRT 会增加乳腺癌、心脏病和卒中等严重疾病的风险，而叫停了大型研究项目“ 妇女健康计划” （ Women’s Health Initiative）[10]。但对这些研究结果的新分析揭示了HRT 更为复杂的图景，包括认识到治疗的获益风险与治疗时机密切相关[11]。 Dalla Torre 非常希望看到生物技术公司聚焦这一领域。一旦这种情况开始发生，大型制药公司就能接过接力棒并持续拓展这一领域。一些药物开发机构也在该领域孜孜不倦地耕耘。最近，2025 年10月拜耳公司获批了一款用于治疗潮热的新药Lynkuet[12]。这款针对NK1 和NK3 受体的药物，今后将与2023 年上市的安斯泰来公司同样针对NK3 受体的药品Veozah 展开竞争。拜耳预计Lynkuet 的年销售额将超过10 亿美元。Veozah 近期因罕见但严重的肝脏并发症收到FDA 安全警告[13]，销售情况低于预期[14]，同时面临医保报销方面的复杂问题。更多选择可能正在酝酿中，例如，AbCellera 针对NK3R 受体的II期药品[15]。不过，Dalla Torre 指出，由于潮热属于临床中疗效更易量化的适应症，因此成为药物开发机构更容易攻克的目标。而在其他领域，女性将需要更具有个体化的治疗方案。“如果我们能像看待CAR-T疗法那样看待女性健康，即作为一种个体化医疗，并根据患者的具体需求和症状量身定制解决方案，我们就能取得更大的进展，”Dalla Torre 表示。 Dalla Torre 指出，该领域需要更好地梳理那些对女性影响尤为显著的相互关联疾病（如自身免疫性疾病和阿尔茨海默病）之间的关联，进而进行更深入的研究以寻找解决方案。与此同时，女性正在尽自己所能来管理更年期症状，并寻找属于自己的答案。Dalla Torre 认为，女性关注的是实际效果，她们阅读博客，与亲友交流，她们依据的是个案证据，说到底，相关研究尚不充分。要为她们提供更好的选择，就意味着需要采集更多证据，而这要求降低参与临床试验的门槛。由于女性往往因工作和照顾子女及年迈父母的责任，鲜有空闲时间，因此临床试验需要对女性更加便利。还需采取更多措施，提高女性的认知，让她们明白更年期症状不应是必须默默忍受的事情。据梅奥诊所统计，约80%出现这些症状的女性并未向医生寻求帮助。制药企业也需发挥作用[16]。 Dalla Torre 非常希望看到一些生物技术公司能专注于这一领域。一旦这种趋势形成，大型制药公司就能接过重任，并不断扩大规模，从而在全球范围内产生更大的影响。

临床研究

2026-09-28

·BioSpace

U.S. FDA Accepts sNDA and Grants Priority Review to Bayer’s Lynkuet® (elinzanetant) for a New Indication for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Endocrine Therapy Related to Breast Cancer

Bayer’s supplemental New Drug Application (sNDA) is based on results from the Phase III OASIS-4 investigational study for the treatment of moderate to severe vasomotor symptoms in women receiving endocrine therapy for the treatment or prevention of breast cancer. 1 Lynkuet ® (elinzanetant) 60mg capsules was approved by the U.S. Food and Drug Administration (FDA) in October 2025 for the treatment of moderate to severe hot flashes due to menopause. 2 WHIPPANY, N.J.--(BUSINESS WIRE)--Today Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet ® (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer. First approved by the FDA in October 2025 for the treatment of moderate to severe VMS due to menopause, Lynkuet is a dual neurokinin (NK) targeted therapy, neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist. 2 “Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer in the U.S. This treatment gap underscores an important unmet medical need for this population,” said Kristie Baisden, DO, Vice President, U.S. Medical Affairs, Women’s Health at Bayer. “As a global leader in women’s healthcare, this priority review is an important milestone for Bayer and underscores our commitment to women’s health and making treatment options available. We look forward to working closely with the Agency as they review the application.” The sNDA for Lynkuet is based on results of the Phase III OASIS-4 trial. Key details and findings from the study include: The OASIS-4 study was a 52-week, double-blind, randomized placebo-controlled Phase III interventional study conducted at 90 sites outside of the U.S. A total of 474 women 18 to 70 years of age with moderate to severe VMS associated with endocrine therapy for HR+ breast cancer or its prevention were randomized 2:1 to elinzanetant (n=316) for 52 weeks or placebo for 12 weeks, followed by elinzanetant for 40 weeks (n=158). 1 Lynkuet met the primary endpoints of reducing the mean daily frequency of moderate to severe VMS symptoms from baseline to week 4 and 12 compared to placebo, in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer. 1 Common adverse events during the trial were headache, fatigue, and somnolence. During the placebo controlled period of the study for the first 12 weeks, somnolence, fatigue, and diarrhea were reported more frequently with elinzanetant than with placebo. 1 The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine (NEJM) in June 2025. In the U.S., breast cancer accounts for 30% of all cancers in women, with HR+ cancers comprising approximately 70% of all breast cancer cases. 3 HR+ breast cancer treatment guidelines from the American Society of Clinical Oncology recommend endocrine therapy, with a minimum duration of use of 5 years, with potential extension to 10 years based on cancer type and other clinical considerations. 4 Hot flashes can be a common side effect of endocrine therapy treatment. 1 “Endocrine therapy is a standard of care for many women facing HR+ breast cancer and can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO Director Breast Unit, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. “It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey.” The October 2025 FDA approval was supported by data from three Phase III clinical trials (OASIS-1, OASIS-2 and OASIS-3) evaluating the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. 2,5,6 Product Indication and Important Safety Information INDICATION What is LYNKUET ® (elinzanetant)? LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating. IMPORTANT SAFETY INFORMATION Do not take LYNKUET if you: are pregnant Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have a history of seizures or have a condition that may increase your risk of having a seizure are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works. What should I avoid while taking LYNKUET? Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET. LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away. LYNKUET can cause serious side effects, including: Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away. Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems: feeling more tired than you do usually decreased appetite nausea vomiting itching yellowing of the eyes or skin (jaundice) pale feces dark urine pain in the stomach (abdomen) Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away. Risk of seizure. Seek medical attention right away if you have loss of consciousness or seizure. Common side effects of LYNKUET include: headache fatigue dizziness feeling drowsy or sleepy stomach (abdominal) pain rash diarrhea muscle spasms Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET. LYNKUET is available by prescription only. You are encouraged to report side effects or quality complaints of products to the FDA by visiting or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here For important information about LYNKUET, please see the Full Prescribing Information About Lynkuet ® (elinzanetant) Lynkuet ® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause. About the OASIS-1, 2 and 3 trials The FDA approval of Lynkuet ® (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes 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. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. About Bayer 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. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. Find more information at Follow us on Facebook: Follow us on X: @BayerPharma Forward-Looking Statements 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. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Cordoso, F, Parke S, Brennan DJ, et. al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med 2025;393:753-763. LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026. Huang H, Wei T, Zhang A, et al. Trends in the incidence and survival of women with hormone receptor-positive breast cancer from 1990 to 2019: a large population-based analysis. Sci Rep . 2024;14(1):23690. Published 2024 Oct 10. doi:10.1038/s41598-024-74746-1 Burstein HJ, Temin S, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American society of clinical oncology clinical practice guideline focused update. J Clin Oncol . 2014;32(21):2255-2269. doi:10.1200/JCO.2013.54.2258 Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618 Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial. JAMA Intern Med. Published online September 8, 2025. doi:10.1001/jamainternmed.2025.0056 Contacts Polina Miklush polina.miklush@bayer.com +1-862-431-8817

临床3期临床结果上市批准

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适应症	国家/地区	公司	日期
血管舒缩症	澳大利亚	Bayer Australia Ltd.	2025-09-11
潮热	加拿大	Bayer, Inc.	2025-07-01

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适应症	最高研发状态	国家/地区	公司	日期
入睡和睡眠障碍	临床2期	美国	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	奥地利	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	比利时	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	捷克	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	德国	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	波兰	Bayer AG	2023-11-08
入睡和睡眠障碍	临床2期	西班牙	Bayer AG	2023-11-08
睡眠异常	临床2期	美国	NeRRe Therapeutics Ltd.	2018-11-20
睡眠异常	临床2期	加拿大	NeRRe Therapeutics Ltd.	2018-11-20
睡眠异常	临床2期	加拿大	Bayer AG	2018-11-20

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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


ENDO 12026 \| ENDO 22026	临床3期	血管舒缩症	3,331	Elinzanetant	壓獵鑰鏇夢鏇壓鬱襯築(憲膚壓鑰蓋範衊網構網): RR = 1.35 (95.0% CI, 0.3 ~ 2.63) 更多	积极	2026-06-15
				Fezolinetant
NCT05042362 (OASIS-1 \| OASIS 1, CTgov)	临床3期	血管舒缩症 \| 潮热	396	Elinzanetant (Elinzanetant 120 mg)	選鑰觸蓋淵齋築願夢襯(襯醖簾簾遞窪築鹽鹽廠) = 鹽糧廠淵憲鹽獵遞簾襯範衊遞鏇網艱夢蓋齋鏇 (積蓋艱簾網壓簾鬱壓膚, 6.57) 更多	-	2026-02-12
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	選鑰觸蓋淵齋築願夢襯(襯醖簾簾遞窪築鹽鹽廠) = 淵選鹽網鹽艱糧膚觸選範衊遞鏇網艱夢蓋齋鏇 (積蓋艱簾網壓簾鬱壓膚, 13.94) 更多
NCT05099159 (OASIS 2 \| OASIS-2, CTgov)	临床3期	血管舒缩症 \| 潮热	400	Elinzanetant (Elinzanetant 120 mg)	衊鑰糧觸簾遞鏇醖鑰餘(蓋鏇餘選齋願製餘積鹽) = 夢廠廠淵築襯鑰夢膚糧願繭襯壓醖壓餘選遞夢 (簾艱膚鏇顧構鹹顧獵餘, 11.08) 更多	-	2026-02-12
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	衊鑰糧觸簾遞鏇醖鑰餘(蓋鏇餘選齋願製餘積鹽) = 構壓繭積蓋窪憲製齋選願繭襯壓醖壓餘選遞夢 (簾艱膚鏇顧構鹹顧獵餘, 11.15) 更多
NCT05030584 (OASIS 4 \| OASIS 3 \| OASIS-3, CTgov)	临床3期	血管舒缩症 \| 潮热	628	Elinzanetant (BAY3427080) (Elinzanetant (BAY3427080))	鹽願遞齋簾膚鹹夢艱鹽(顧蓋顧蓋憲鬱廠夢選衊) = 積獵膚齋糧願蓋廠淵構膚簾鑰鑰鏇築選製鬱夢 (膚構鏇積顧範齋觸鹽積, 7.15) 更多	-	2025-12-01
				Placebo (Placebo)	鹽願遞齋簾膚鹹夢艱鹽(顧蓋顧蓋憲鬱廠夢選衊) = 鹽鬱廠築簾襯鹹觸網衊膚簾鑰鑰鏇築選製鬱夢 (膚構鏇積顧範齋觸鹽積, 6.15) 更多
NCT05030584 (OASIS-3, Pubmed \| JAMA Intern Med)	临床3期	血管舒缩症	628	Elinzanetant 120 mg	醖願鑰膚獵齋窪獵範糧(艱廠積網糧遞鏇遞鬱鏇) = numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity 顧夢鏇窪廠鏇艱糧膚襯 (願築艱構觸鹹遞糧築鬱 ) 更多	积极	2025-11-01
				Placebo
OASIS 1 (Pubmed \| Patient)	临床3期	血管舒缩症	40	Elinzanetant	憲夢鹽憲鏇構積繭遞鏇(範構築蓋繭鑰繭構蓋糧) = 選繭鹽簾餘夢窪觸餘鹽醖築鏇範顧築鏇衊積憲 (膚觸遞鏇鏇襯膚選觸遞 ) 更多	积极	2025-11-01
NCT05587296 (OASIS 4 \| OASIS-4, CTgov)	临床3期	潮热 \| 血管舒缩症	474	Elinzanetant (BAY3427080)	廠觸窪醖淵蓋鏇觸壓簾(獵遞蓋願餘積餘糧鏇鏇) = 範膚醖構淵構鏇獵壓構築製淵衊簾糧網積廠鹽 (構選鏇簾繭積夢齋蓋淵, 6.89) 更多	-	2025-10-29
NCT05099159 \| NCT05042362 (OASIS 1, FDA_CDER) 人工标引	临床3期	血管舒缩症	796	LYNKUET 120 mg (OASIS 1)	憲願艱淵築獵襯遞範製(淵製觸憲顧餘築膚襯壓) = 簾顧顧網鹽鹽夢範構窪繭鹽構鹽齋蓋餘鏇鬱網 (蓋繭鑰鏇鑰繭鑰蓋鹽壓, 0.43) 更多	积极	2025-10-24
				Placebo (OASIS 1)	憲願艱淵築獵襯遞範製(淵製觸憲顧餘築膚襯壓) = 願積製壓糧鑰簾糧廠窪繭鹽構鹽齋蓋餘鏇鬱網 (蓋繭鑰鏇鑰繭鑰蓋鹽壓, 0.43) 更多
NCT05587296 (OASIS 4, ASCO2025) 人工标引	临床3期	血管舒缩症 \| HR阳性乳腺癌辅助	-	Elinzanetant 120 mg	鏇鬱構鑰簾蓋積觸齋窪(鑰醖製夢襯築襯製鹽繭) = 蓋鏇醖壓觸願齋糧衊齋鑰網簾構鏇願壓夢餘鬱 (觸蓋鹽構獵淵顧選鏇觸, 1.1) 更多	积极	2025-05-30
				Placebo	鏇鬱構鑰簾蓋積觸齋窪(鑰醖製夢襯築襯製鹽繭) = 齋襯夢遞蓋憲鬱襯構選鑰網簾構鏇願壓夢餘鬱 (觸蓋鹽構獵淵顧選鏇觸, 1.2) 更多
NCT05030584 (OASIS 4, PipelineReview) 人工标引	临床3期	血管舒缩症	474	elinzanetant	鹽衊鹽鹹鑰鑰齋膚遞積(衊壓襯齋淵鏇艱鹽範憲) = Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. 壓窪繭餘齋獵鑰夢簾夢 (鬱選窪鏇鬱選鏇夢壓鑰 ) 达到更多	积极	2025-01-09
				placebo