(22423 NIRVANA) A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause - 22423

开始日期2024-03-26

申办/合作机构

Bayer Consumer Care AG

[+1]

NCT06219902

/ Completed临床1期

A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women

Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
dose A of elinzanetant and a zopiclone placebo
dose B of elinzanetant and a zopiclone placebo
zopiclone 7.5 milligrams (mg) and elinzanetant placebo
elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
check the level of the study drugs in participants' blood
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.

开始日期2024-01-08

申办/合作机构

Bayer AG

NCT06112756

/ Completed临床2期

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.
Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.
The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.
The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.
For this, the researchers will analyze
* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.
The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.
Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.
During the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check vital signs
* do sleep tests
* use an electronic hand-held device to record sleep quality and hot flashes at home
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-11-08

申办/合作机构

Bayer AG

100 项与 Elinzanetant 相关的临床结果

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100 项与 Elinzanetant 相关的转化医学

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100 项与 Elinzanetant 相关的专利（医药）

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项与 Elinzanetant 相关的文献（医药）

2025-04-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Efficacy and safety of elinzanetant in vasomotor symptoms associated with menopause: A meta-analysis of randomized controlled trials

Review

作者: Alvarez-Galiana, Veronica ; Peres, Clara de Andrade Pontual ; da Rocha, Naila Camila ; de Moraes, Marina Ayabe Gomes ; Barbosa, Abner Mácola Pacheco ; Rodrigues, Livia Kneipp ; Furtado, Claudio Lucca Lima ; da Silva, Danieli Pereira ; Sobral, Milene Vitória Sampaio ; Rocha, Paula

OBJECTIVE:

To evaluate the efficacy and safety of elinzanetant compared to placebo in patients experiencing vasomotor symptoms (VMS) associated with menopause.

METHODS:

A systematic search of PubMed, Embase, and Cochrane databases identified randomized clinical trials (RCTs) comparing elinzanetant and placebo in patients with menopause-related VMS. Statistical analyses pooled mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) using R Studio 4.3.2. Pre-specified outcomes included frequency and intensity of VMS, quality of life, and sleep disturbance.

RESULTS:

This meta-analysis included three randomized clinical trials reporting data on 995 patients, with 551 receiving elinzanetant. The mean age ranged from 54.4 to 55.6 years. Elinzanetant significantly reduced VMS frequency (MD -3.09; 95 % CI -4.18 to -2.01; I² = 0 %) and intensity (MD -0.32; 95 % CI -0.43 to -0.21; I² = 39 %). Improvements in quality of life were demonstrated by reduced scores on the Menopause-Specific Quality of Life Questionnaire (MD -0.46; 95 % CI -0.63 to -0.30; I² = 35 %) and better sleep quality measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (MD -4.65; 95 % CI -5.56 to -3.73; I² = 0 %). The incidence of adverse events was similar between groups (RR 1.11; 95 % CI 0.99 to 1.25; I² = 35 %).

CONCLUSION:

Elinzanetant reduces the frequency and intensity of VMS and enhances quality of life and sleep quality in patients with menopause-related symptoms. Its safety profile is comparable to placebo.

2025-04-01·MATURITAS

Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis

Review

作者: Barbosa, Lucas Mendes ; Flávio-Reis, Victor Hugo Palhares ; Gonçalves Barbosa Júnior, Osvaldo ; Diaz, Camilo André Viana ; Zamora, Fernanda Valeriano ; de Oliveira, Helen Michaela

OBJECTIVE(S):

Menopause, marked by a decline in estrogen, leads to disruptive vasomotor symptoms like hot flashes and night sweats, significantly affecting quality of life. This meta-analysis evaluated the efficacy and safety of fezolinetant and elinzanetant, two neurokinin 3 receptor antagonists, in managing vasomotor symptoms in postmenopausal women.

METHODS:

Data sources were identified by searches in PubMed, Embase, and the Cochrane Central Register of Controlled Trials up to September 2024. The study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, with the risk of bias assessed using the version 2 of the Cochrane Risk of Bias Tool for Randomized Trials and evidence quality was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Data were pooled using a random-effects model, and statistical analysis was performed using R version 4.4.1.

RESULTS:

Ten studies involving 4663 patients were included in the analysis. Elinzanetant >100 mg and fezolinetant ≤45 mg were the most effective doses for reducing vasomotor symptom frequency and severity. Fezolinetant (MD = -1.38) and elinzanetant (MD = -2.04) achieved ≥50 % reductions in vasomotor symptom frequency, with a greater effect in the elinzanetant group. Additionally, elinzanetant improved menopause-specific quality of life. However, higher doses of both drugs were associated with increased adverse effects, with elinzanetant demonstrating a more favorable side-effect profile than fezolinetant.

CONCLUSIONS:

Fezolinetant and elinzanetant are effective options for managing vasomotor symptoms. However, further research is needed to compare these treatments directly and evaluate their long-term safety profiles across different patient populations.

2025-03-04·EXPERT OPINION ON PHARMACOTHERAPY

Will elinzanetant, a neurokinin receptor antagonist, have a role in the treatment of hot flashes?

Review

作者: Doggrell, Sheila A.

INTRODUCTION:

The use of hormonal treatment for the vasomotor symptoms (VSM) associated with the menopause is back in favor, as the adverse effects reported in the early 2000s have been dispelled. However, many women are still reluctant to use, or have contraindications to, hormonal therapy. Elinzanetant is a combined neurokinin (NK)-1 and -3 receptor antagonist, being trialed for menopausal symptoms.

AREA COVERED:

A combination of OASIS 1 and 2 in the menopause showed that elinzanetant caused a reduction in the frequency and intensity of VSM and may also independently reduce sleep disturbances. Adverse effects were low with elinzanetant.

EXPERT OPINION:

Further study is needed to clarify whether elinzanetant reduces sleep disturbance and whether this is due to antagonism at NK-1 receptors. If further studies support OASIS 1 and 2, elinzanetant maybe considered for use in hot flashes associated with the menopause, in subjects where hormonal therapy is contraindicated or not accepted. Fezolinetant, an NK-3 receptor antagonist, has recently been registered for VSM associated with the menopause. Fezolinetant does not have a clear-cut effect on sleep disturbances independent of VMS. Only, if elinzanetant can be shown to independently reduce sleep disturbances, it may have an advantage over fezolinetant.

128

项与 Elinzanetant 相关的新闻（医药）

2025-04-13

·药事纵横

案例之二：拜耳的战略（2024年）

一、集团战略全球人口的持续增长和日益老龄化‌,以及自然生态系统压力与日俱增，‌是当前人类面临的主要挑战。作为健康与营养领域的全球领导者，我们的使命是"全民健康，消除饥饿（Health for all, Hunger for none）"。在这一使命的指导下，我们做出了通过产品和服务持续改善人类生活质量的承诺。我们将致力于提升营养与医疗服务的可及性‌，同时减少农业全产业链及企业自身的生态足迹‌。我们不仅强调产品与解决方案的开发与创新，还将持续推动业务流程的数字化‌。我们将继续在监管严格且利润丰厚的创新驱动型行业深耕，并以“超行业增速”为发展目标‌。此外，我们将持续优化资源配置与成本结构‌，以实现业务成长、盈利与可持续性的协同发展‌。我们的业务运营可为联合国可持续发展目标（SDGs）的达成做出贡献‌，同时在全价值链推行基于科学的气候行动方案‌。‌2023年，我们开始深化战略与公司使命的契合度‌。作为公司战略的核心元素，我们引入了“动态共享责任制（Dynamic Shared Ownership）”的运营模式‌。该模式以员工自主管理团队为基础‌，以充分释放创造力与专业能力‌。我们的目标是加速创新，为农民、患者和消费者提供更好的支持与帮助。‌我们将动态回顾战略‌，以确保公司能够灵活应对经济与政策环境的变化‌，并在全集团范围内推行新型运营模式‌。通过这些改革，我们致力于实现三大目标：1）提升员工的生产力与满意度；2）‌加速全球领先创新产品上市；3）持续提升财务表现。所有业务活动均基于其对公司使命的贡献度进行优先级排序‌，并以90天为周期评估进展‌。此举旨在让公司变得更灵活‌，减少跨部门协调成本及管理层级冗余‌。各业务单元的具体战略将遵循上述框架展开‌。二、业务层战略1. 作物科学业务在全球气候变化和人口持续增长的双重压力下，农业迎来了转型关键期。农业生产主体亟需探索资源集约型发展道路，以可持续方式保障粮食安全、能源供给及纺织纤维需求。这些挑战‌加速了行业的颠覆性变革‌，不仅‌重构了价值链的竞争格局‌，还‌催生出新型参与者‌和新市场机会。在这充满变革的产业环境中，创新的速度与规模、可为客户带来可持续发展的成果交付能力是制胜的关键。我们的目标是在未来十年内推出10款年销售额超5亿欧元的重磅产品‌，以创新技术赋能全球农户。依托覆盖种子&性状（Seeds & Traits）、作物保护及数字农业（Digital Farming）的创新管线，深度融合的数字化生态体系，遍布全球的业务网络与合作关系，我们正着力打造紧贴客户需求的敏捷型组织架构，聚焦培育具有抗风险能力的商业模式。另外，在系统化解决方案创新方面，我们已形成突破性成果矩阵：‌Preceon™智能玉米系统‌、新一代耐除草剂大豆品种、30年来首个苗后广谱除草剂新作用机理，以及颠覆性的技术储备，包括小麦杂交种、水稻直播技术（DSR）、亚非玉米生物技术性状、生物源植保产品及碳汇农业系统。在人工智能领域，我们正通过‌植保化学创新标杆技术CropKey‌，实现新植保产品研发在精准性、安全性及可持续性方面的革命性突破。通过将产品组合与数字洞察相融合，能够倍增农户收益‌。例如我们开发的Climate FieldView™数字农业平台就是这种实践的典范‌。在B2B领域，我们依托AgPowered Services等数字化平台创造价值‌。数字化战略的深化实施显著加速了创新的进程，推动了全链条流程自动化升级，改善了研发成功率。我们的愿景是通过规模化推广再生农业系统，构建更高产、更稳定的粮食生产体系‌。为了实现这一愿景，我们构建了“Produce 50% More（增产50%以上）”、“Restore Nature（自然修复）”、“Scale Regenerative Agriculture（规模化再生农业）”三大战略支柱‌‌。我们将在2030年以前实现的一大重要目标是，“通过提升中低收入国家小农户对‌农产品、服务及合作伙伴关系‌的获取渠道，累计支持‌1亿户小农户‌‌”。2. 制药业务随着人口老龄化的不断加剧和‌慢病发病率的持续上升‌，越来越多患者因多种病症叠加而生活质量受损‌。而细胞与基因疗法、精准医学等领域的科学突破，有望治愈需求最迫切的患者，甚至实现疾病预防‌，这为制药市场提供了巨大的机遇。与此同时，全球医疗系统成本上升也对药品定价及新药成本效益评估模式形成了压力‌。为此，我们制定了明确的战略优先级：1）最大化上市产品的价值，2）通过成功发布新品扩大收入，3）推进晚期阶段的研发管线。在‌充分发掘现有产品组合潜力‌的同时‌，着力开发‌新增长引擎‌，包括四款具有显著销售潜力的新药（Nubeqa、Kerendia、elinzanetant‌、acoramidis‌），以及正在开发二级中风预防适应症的‌asundexian‌ 。我们正集中‌营销与研发资源‌推动这些战略性产品的成功商业化，另外，鉴于美国市场的高增长潜力，公司将持续地投资。为保障长期增长‌，我们将持续投资研发以构建创新的、差异化且可持续的研发管线‌。业务聚焦于抗肿瘤、心血管、神经系统、罕见病、免疫系统等具有高临床价值与市场潜力的治疗领域‌。为了持续提升研发效率与效能，我们将构建以在研产品为核心的组织架构、实施动态资源配置、深化数据科学与人工智能技术应用。除了强化内部研发能力，我们还将持续投资平台性公司。BlueRock Therap与Asklepios BioPharma正稳步推进突破性细胞与基因疗法开发，Vividion Therap有助于强化我们的新药发现能力，尤其是在抗肿瘤与免疫领域。此外，我们通过研发合作与授权引进加速获取外部创新，以持续把握生物制剂与新兴技术带来的发展机遇‌。除了提升药品可及性，我们的另一核心要务是改善女性健康状况并强化其社会角色。依托在妇女保健领域的市场领导地位‌，我们的目标是到2030年，每年为中低收入国家1亿女性提供现代避孕药具获取渠道‌。此外，我们还将持续推进抗击热带病及非传染性疾病的行动‌。3. 消费者保健业务消费者健康意识的持续提升‌、总人口的不断增长与人口结构的不断变化，以及医疗成本的逐步攀升，推动着消费保健市场长期向好的发展态势。消费者对自我护理、疾病预防及整体健康的关注度显著增强‌，预计将持续驱动所有核心消费者保健品类的增长‌。我们同时预判消费渠道将持续向电商平台转移。我们将继续为消费者提供有助于改善日常健康的产品、服务及信息，并拓展业务版图以覆盖全球更多人口。战略聚焦于品类的培育与延伸，以及将处方药转化为OTC。为了推动业务强势而可持续的增长，我们将采用“以科学为本且值得信赖的品牌”和“持续推出创新型新产品”为抓手。在业务运营中，我们采用‌敏捷的资源配置机制‌‌，优先聚焦‌前瞻性增长机会，旨在通过品牌影响力赢得消费者信任。与此同时，我们还强调“为零售伙伴创造价值及‌深化与专业医疗机构的合作关系”，将致力于提升‌全价值链的生产力、柔性与韧性‌‌，以强化‌成本与资金效能‌‌，并同步降低对环境的影响。另外，我们还将通过内部创新与外部合作‌，以持续地发展现有品牌树和交付创新，通过并购与合作‌，以获取“可为市场带来‌个性化诊疗解决方案”的新商业模式及新能力。我们的目标是到2030年，每年为经济或医疗资源薄弱地区的1亿人口提升自我护理服务的可及性‌‌。为实现这一目标，我们将可持续性‌全面融入了运营体系‌‌，以开发‌精准匹配消费者需求‌的解决方案，尤其关注‌以自我护理为核心健康管理方式‌‌的群体。参考阅读案例之一：罗氏的战略（2024年）药事纵横投稿须知：稿费已上调，欢迎投稿

医药出海核酸药物

2025-04-02

·拜耳中国

2025年将成为拜耳处方药里程碑式的上市年

用于治疗转甲状腺素蛋白淀粉样变性心肌病的心脏病药物Beyonttra®（acoramidis）已在欧洲成功获批非激素类创新药elinzanetant用于治疗与更年期相关的中重度血管舒缩症状（VMS，也称为潮热），预计2025年在美国和欧洲上市达罗他胺在前列腺癌治疗领域的第三个适应症，以及非奈利酮的第二个适应症——用于治疗一种常见心力衰竭（心衰）——预计在2025年下半年上市凭借在眼科领域的领导地位，潜在重磅药物EyleaTM 8mg（阿柏西普8mg）在第三个适应症的III期临床试验中取得积极结果，很快将向欧盟提交上市许可申请在帕金森病治疗领域推进细胞疗法和基因疗法的旗舰项目启动并推进心血管/肾脏和肿瘤等重点治疗领域的多个创新和差异化项目的临床开发近日，在拜耳处方药2025年全球媒体日之际，公司展示了其处方药事业部的增长战略和研发管线的重大进展。公司正在扩展其心脏病学产品组合，推出Beyonttra®，用于治疗转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM），并计划在年底前推出非奈利酮（可申达®），用于治疗常见心衰，即左心室射血分数（LVEF）≥40%的心衰。同时，elinzanetant作为治疗更年期女性中重度血管舒缩症状的非激素类疗法，预计将在2025年夏末首次上市。在肿瘤领域，公司增长动力达罗他胺（诺倍戈®）的第三个适应症预计将在2025年获得在美国的批准，允许达罗他胺与雄激素剥夺疗法（ADT）联合使用，治疗转移性激素敏感性前列腺癌（mHSPC）成年患者。“2025年是拜耳处方药具有里程碑意义的上市年，公司正在全力以赴推动研发管线进展，”拜耳集团管理委员会成员、拜耳处方药事业部全球总裁Stefan Oelrich表示。“我们的增长战略进展顺利，并产生了巨大价值。今年，我们将向市场推出多款具有重磅药物潜力的突破性产品。”具有重磅药物潜力的6款产品向上滑动阅览诺倍戈®（达罗他胺）拜耳计划于2025年推出诺倍戈®的第三个适应症，ARANOTE试验的有力数据为其提供了支持，该试验研究了达罗他胺联合ADT相较于安慰剂联合ADT治疗mHSPC患者的有效性和安全性。诺倍戈®已获批联合ADT和多西他赛治疗mHSPC。此外，它还获批联合ADT治疗具有高危转移风险的非转移性去势抵抗性前列腺癌（nmCRPC）成年患者。可申达®（非奈利酮）在FINEARTS-HF III期临床研究中，非奈利酮在心衰患者（LVEF ≥40%）中显示出心血管结果的统计学显著改善。基于此积极数据，拜耳已在美国、欧盟、中国和日本提交了该适应症的上市申请。非奈利酮是唯一一款在III期研究中证明对LVEF≥40%的心衰患者具有心血管获益的盐皮质激素受体（MR）通路的靶向药物。非奈利酮已获批用于治疗与2型糖尿病相关的慢性肾脏病（CKD）成人患者。Beyonttra® (acoramidis)今年2月，欧盟委员会批准了acoramidis（商品名为Beyonttra®）的上市许可，用于治疗野生型或变异型转甲状腺素淀粉样变性的患有心肌病的成年患者（ATTR-CM）。ATTR-CM是一种进行性致死性疾病，通过浸润性、局限性心肌病导致心衰。由于心脏内持续存在淀粉样物质沉积，患者面临疾病持续进展的风险。Beyonttra®是一种高选择性小分子、口服给药的、接近完全（≥90%）的转甲状腺素蛋白（TTR）稳定剂。该药物已在欧洲成功上市，德国是首个上市国家。Elinzanetant在三项III期临床试验（OASIS-1、2、3）中，elinzanetant已成功证明其在减少与更年期相关的中重度血管舒缩症状（VMS，也称为潮热）的有效性和安全性。今年1月，III期OASIS 4临床取得了积极成果，达成其主要终点，证明了elinzanetant在治疗接受乳腺癌辅助内分泌治疗或患乳腺癌风险较高的女性中重度VMS方面的有效性。在所有四个III期临床试验中，参与者的睡眠障碍和与更年期相关的生活质量方面也有所改善。Elinzanetant正在全球多个市场申请上市许可，拜耳预计其今年将在美国和欧洲获批。EyleaTM 8mg（阿柏西普8mg）在眼科治疗领域，EyleaTM 8mg以其更长的治疗间隔，将有望成为其已获批适应症——新生血管（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）——新的标准治疗。2024年12月，全球III期QUASAR研究表明，对于视网膜静脉阻塞（RVO），包括中央、分支和半侧视网膜静脉阻塞，继发黄斑水肿的患者，与当前的标准治疗（艾力雅®2mg每月）给药相比，阿柏西普8mg可以实现给药频率更低的同时，在视力改善方面也具有非劣疗效。详细结果将提交给全球多个卫生监管机构。AsundexianAsundexian是一种选择性口服FXIa抑制剂，作为一种潜在的新型抗血栓疗法，目前正在研究用于预防接受标准抗血小板治疗的患者的缺血性卒中复发。FXIa抑制的机制假设是将卒中预防与出血风险解耦。OCEANIC-STROKE III期临床研究进展顺利，研究了接受标准抗血小板治疗的患者在非心源性缺血性卒中或高危短暂性脑缺血发作后的卒中预防。该研究将于今年晚些时候完成。该适应症此前曾获得美国食品药品监督管理局（FDA）的快速通道资格。影像诊断业务的新对比剂拜耳影像诊断业务提供全面的对比剂产品组合，并显著推进了其磁共振（MRI）的创新研发管线。III期临床研究QUANTI探索了含钆的MRI对比剂gadoquatrane在儿科和成人患者中的广泛潜在适应症，成功达到了主要和全部关键次要终点。与按0.1 mmol Gd/kg体重给药的对照组相比，gadoquatrane的钆剂量减少了60%。减少钆剂量对于需要重复进行对比增强MRI检查的患者以及儿科等弱势患者尤为重要。拜耳计划向全球多个卫生监管机构提交上市申请。帕金森病细胞疗法和基因疗法居领导地位拜耳细胞和基因疗法平台取得了关键进展，达成了重要的临床试验里程碑，特别是在帕金森病领域。Bemdaneprocel是一种在研细胞疗法，通过手术将生成多巴胺的神经细胞前体植入大脑。根据I期临床试验exPDite的积极数据，它将直接推进至帕金森病的III期临床。美国食品药品监督管理局（FDA）已授予bemdaneprocel再生医学先进疗法认定（RMAT），认可其在治疗帕金森病方面的创新潜力。AB-1005是一种治疗帕金森病的在研基因疗法，目前正处于II期临床阶段。REGENERATE-PD临床试验已迎来随机化分组受试者。AB-1005基于腺相关病毒（AAV），将人胶质细胞源性神经营养因子（GDNF）转基因输送到大脑，有可能恢复产生多巴胺的神经元的功能。根据初步临床证据，美国FDA 授予 AB-1005 RMAT 资格，因为它具有减缓中度帕金森病患者病情进展和改善运动结果的潜力。此外，英国药品与保健品监管局（MHRA）授予AB-1005创新通行证认定。来自美国和英国的两项认定突显了AB-1005在帕金森病领域满足全球重大未满足医疗需求的潜力。作为转型的一部分，拜耳聚焦重点研发领域，为肿瘤、心血管疾病和肾脏病、神经学和罕见病、免疫学领域的长期增长建立了高度差异化的研发管线。通过严格的评估和优先排序，拜耳处方药目前完全专注于具有最大未满足需求和最高价值潜力的领域。推进精准肿瘤研发在精准肿瘤治疗领域，口服小分子酪氨酸激酶抑制剂（在研药物BAY 2927088）是针对携带HER2激活突变的非小细胞肺癌（NSCLC）患者的潜在新靶向治疗。在正在进行的评估其安全性和有效性的SOHO-01 I/II期临床研究中，该药物作为二线治疗显示出积极的结果，其潜力得到了美国FDA和中国国家药品监督管理局药品评价中心（CDE）的突破性疗法认定。此外，BAY 2927088还在SOHO-02 III期临床试验中评估作为一线治疗的潜力，针对肿瘤具有HER2激活突变的晚期NSCLC患者。针对携带HER2激活突变的转移性或不可切除实体瘤的成人患者，BAY 2927088的有效性和安全性也在全球panSOHO II期临床试验中进行了研究。最近，在晚期KRAS突变肿瘤患者中还启动了一项I期临床试验，研究药物为BAY 3498264，是一种口服选择性SOS1抑制剂。靶向放射性核素治疗（TRT）是拜耳精准肿瘤药物开发的战略重点领域。多菲戈®是首个也是唯一针对转移性去势抵抗前列腺癌症患者的靶向α治疗方案。基于多菲戈®十余年真实世界经验，拜耳不断发展的TRT产品组合包括新的靶向方法，将α放射性核素（如锕-225）与不同的靶向部分（包括抗体、小分子或肽基分子）结合起来。作为靶向PSMA（前列腺特异性膜抗原）的候选药物，225Ac-pelgifatamab（BAY 3546828）和225Ac-PSMA-Trillium（BAY 3563254）目前正在晚期转移性去势耐受性前列腺癌症（mCRPC）患者中进行I期临床试验。近年来，对研发和平台公司的定向投资加强了拜耳的早期和晚期研发管线。随着Vividion收购Tavros Therapeutics，拜耳继续利用其化学蛋白质组学技术平台，通过精确的小分子疗法，解锁传统上难以成药的靶点。拜耳已经启动了口服KEAP1激活剂在实体瘤中的I期临床试验和口服STAT3抑制剂在实体瘤和血液恶性肿瘤中的I期临床试验，并且还拥有包括针对RAS驱动癌症的RAS-PIK3CA项目在内的新药临床试验申请（IND）支持项目。加强心血管研发管线在心血管疾病领域，拜耳正在推进处于II期临床的治疗药物。用于慢性肾病（CKD）患者的可溶性鸟苷酸环化酶（sGC）激活剂BAY 3283142已进入II期临床。通过血红素非依赖性途径调节sGC，该在研sGC激活剂代表了一类新药，可能在糖尿病肾病等高氧化应激条件下提供优势。通过抗α2抗纤溶酶抗体项目，拜耳正在开发一种基于新模式和作用机制的溶栓剂。这种抗体特异性阻断内源性纤溶酶抑制剂α2AP能够在不增加出血风险的情况下溶解急性栓塞或血栓。目前，这种在研抗体正在针对深静脉血栓形成患者进行II期临床试验评估，并有可能成为具有高度医学相关性的适应症的治疗选择。AB-1002基因疗法目前正在进行一项国际II期临床试验，旨在评估其在治疗充血性心衰（CHF）中的有效性，涉及患有非缺血性心肌病和纽约心脏病协会（NYHA）III级心衰症状且射血分数降低的成年人。关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2024财年，拜耳的员工人数约为93,000名，销售额为466亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

临床3期细胞疗法基因疗法申请上市上市批准

2025-03-05

·BioPharmaDive

Bayer braces for ‘difficult’ year before turnaround pays dividends

Dive Brief:Bayer CEO Bill Anderson is asking investors to bear with the German conglomerate through one more challenging year before a turnaround effort starts showing significant results.The company on Wednesday reported a net loss of 2.55 billion euros, or 2.60 euros a share, in 2024 on sales of 46.6 billion euros, or about $50 billion. Currency exchange rates hurt the companys results, Bayer said. In 2023, Bayer reported a net loss of 2.94 billion euros, or 2.99 euros a share, on revenue of 47.6 billion euros.Next year will be difficult in terms of financial performance, with sales little changed from 2024 and earnings and cash flow falling behind the previous year, Anderson said in prepared remarks. We see an improved trajectory starting in 2026.Dive Insight:Bayer has been around since 1863, growing from a two-man partnership focused on making dyes to one of the largest players in pharmaceuticals, consumer health and crop science. But the companys shares have been in steady decline for almost eight years amid sluggish financial results.Anderson became CEO in 2023 promising a radical realignment of Bayers internal culture that would shed layers of bureaucracy and make the company more nimble and profitable. In the latest earnings announcement, he said the company would be adding profitability at the crop science division to its list of focus areas along with a five-year plan to improve earnings.The outlook boosted Bayers American depositary receipts, which rose more than 6%, to $6.60 apiece,in early trading Wednesday. They have gradually been recovering from a sharp drop in November, when Bayer lowered 2025 earnings guidance. The ADRs traded above $33 in October 2017.Anderson has so far resisted calls to shed any of the companys main business units, as rivals such as Merck & Co., Johnson & Johnson and Novartishave done. We have three great businesses, with attractive long-term prospects, Anderson said Wednesday. We expect them to compete at the forefront of their fields. Whenever thats not the case, were going to take action.In pharmaceuticals, Bayer is fighting through the expiration of patent protection for Xarelto, but Anderson said the company is rejuvenating its pipeline and expects to soon reap the rewards of that effort. Growth in the unit should return in 2027, with margins starting to expand in 2028, Anderson said.Growth will be led by the companys Nubeqa prostate cancer drug and Kerendia kidney disease treatment, which together should bring in sales of more than 2.5 billion euros in 2025, Anderson said.The company is also planning to launch two drugs it sees as future top sellers. In April, Bayer expects to start booking European sales of the heart medicine Beyonttrawhich, according to development partner BridgeBio Pharma, has caught on quickly with U.S. doctors.The company also hoping to start selling a menopause drug called elinzanetant in the U.S. later this year. '

财报高管变更

100 项与 Elinzanetant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Elinzanetant	-	-

研发状态

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
血管舒缩症	申请上市	加拿大	Bayer, Inc.	2024-09-01
潮热	申请上市	美国	Bayer AG	2024-08-02
绝经期综合征	临床3期	美国	Bayer AG	2021-10-29
绝经期综合征	临床3期	加拿大	Bayer AG	2021-10-29
绝经期综合征	临床3期	捷克	Bayer AG	2021-10-29
绝经期综合征	临床3期	德国	Bayer AG	2021-10-29
绝经期综合征	临床3期	意大利	Bayer AG	2021-10-29
绝经期综合征	临床3期	挪威	Bayer AG	2021-10-29
绝经期综合征	临床3期	波兰	Bayer AG	2021-10-29
绝经期综合征	临床3期	葡萄牙	Bayer AG	2021-10-29

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临床结果

适应症

分期

评价

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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


NCT05030584 (OASIS 4, PipelineReview) 人工标引	临床3期	血管舒缩症	474	elinzanetant	積廠夢構積鹹壓艱齋糧(範鹽願觸繭憲蓋憲膚築) = 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. 廠築窪窪構鏇夢築醖顧 (築糧醖齋夢鹽夢簾網鑰 ) 达到更多	积极	2025-01-09
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	临床3期	血管舒缩症	-	Elinzanetant 120 mg	齋餘選鬱醖餘繭醖鹽選(選鹹鹽齋鑰構餘淵襯膚) = 衊願膚願範艱鬱鏇糧鹹簾鬱範糧築鹽憲築鏇鏇 (鑰網遞範蓋餘壓鑰製淵, 6.6)	积极	2024-10-22
				Placebo	齋餘選鬱醖餘繭醖鹽選(選鹹鹽齋鑰構餘淵襯膚) = 膚淵積夢鹹夢繭鹹夢艱簾鬱範糧築鹽憲築鏇鏇 (鑰網遞範蓋餘壓鑰製淵, 13.9)
NCT05030584 (OASIS 3, NEWS) 人工标引	临床3期	血管舒缩症 \| 潮热	-	Elinzanetant	遞顧襯鏇襯餘積遞積繭(膚網積願鑰夢顧築壓構) = 顧糧選醖餘夢鹹繭夢構窪製齋壓淵觸遞鹽製選 (淵觸獵壓夢鑰觸築觸鏇 ) 达到	积极	2024-09-10
				Placebo	遞顧襯鏇襯餘積遞積繭(膚網積願鑰夢顧築壓構) = 憲構壓範簾鹹遞憲鏇顧窪製齋壓淵觸遞鹽製選 (淵觸獵壓夢鑰觸築觸鏇 ) 达到
NCT05042362 (OASIS-1, Biospace) 人工标引	临床3期	潮热	396	Elinzanetant	鹽積獵膚窪顧壓簾構壓(遞鏇衊積夢衊觸鏇壓鹹) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. 觸願積艱襯齋簾淵觸壓 (築餘範積鏇繭憲選鏇窪 )	积极	2024-05-16
NCT05099159 (OASIS-2, Biospace) 人工标引	临床3期	潮热	400	Elinzanetant	淵簾網製繭蓋築蓋觸積(觸範網糧廠鏇淵糧餘壓) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. 範鏇構獵遞襯憲艱積積 (窪選願願淵鏇選遞餘鑰 )	积极	2024-05-16
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview) 人工标引	临床3期	血管舒缩症	400	elinzanetant	願顧獵壓襯夢糧遞襯鏇(積範鏇鹹壓鏇蓋窪構醖) = demonstrating statistically significant reductions 積壓製窪觸衊餘積蓋網 (餘鏇獵襯築顧網醖構繭 ) 达到更多	积极	2024-01-08
				Placebo
NCT03596762 (SWITCH-1, CTgov)	临床2期	血管舒缩症 \| 潮热 \| 睡眠异常	199	Placebo (Placebo)	製醖壓簾製餘糧蓋構廠(簾夢觸願鑰顧糧鹽艱蓋) = 構構製觸憲構衊窪鬱淵繭廠構獵鑰鑰壓蓋膚壓 (鹹齋膚簾鬱醖鑰網鹽構, 4.42) 更多	-	2023-03-10
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	製醖壓簾製餘糧蓋構廠(簾夢觸願鑰顧糧鹽艱蓋) = 獵齋鏇顧製糧簾繭衊遞繭廠構獵鑰鑰壓蓋膚壓 (鹹齋膚簾鬱醖鑰網鹽構, 8.81) 更多
ISRCTN11913515 (Pubmed \| J Clin Endocrinol Metab)	N/A	-	-	Elinzanetant 120 mg	鹹鹽遞鬱鹹餘鬱襯齋網(築膚衊膚衊繭繭範壓顧) = 夢構鏇簾糧鹽蓋構夢願構願積簾鬱餘簾夢廠衊 (窪獵獵艱構齋範膚廠膚 ) 更多	-	2021-02-24
NCT02865538 (RELENT-1, CTgov)	临床1/2期	血管舒缩症	76	placebo+BAY3427080 (Placebo)	襯鹽蓋繭鹽鑰願顧衊齋 = 鬱鑰窪鹽窪蓋鏇顧範糧選構窪繭淵憲構蓋鬱簾 (襯獵窪齋鹽淵膚顧膚齋, 膚膚願觸膚壓製廠憲鹹 ~ 鹹觸網餘遞憲遞構選齋) 更多	-	2021-02-16
				BAY3427080 (50 mg BAY3427080)	鏇糧鬱窪獵醖簾膚繭鏇(襯網製壓糧憲淵襯觸醖) = 淵餘憲艱夢繭膚範鏇繭鬱積壓膚簾膚鑰構觸鑰 (夢簾願糧繭積製顧網積, 90.19) 更多
NCT03596762 (SWITCH-1, ENDO2020)	临床2期	血管舒缩症	199	NT-814 40 mg	鑰範製繭糧築襯範鹹衊(餘襯淵構壓繭選製鏇繭) = NT-814 was well-tolerated; most AEs were mild or moderate and there were no serious AEs related to treatment 願齋範廠網齋網壓鑰壓 (襯簾艱鹽網鑰鏇繭構觸 )	积极	2020-05-08
				NT-814 80 mg