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 tests. Some visits will also include a bone scan (called a DXA scan) and a liver ultrasound. 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 last tablet of study treatment (fezolinetant or placebo).

开始日期2024-06-30

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.

NCT06206408 / Recruiting临床3期

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing 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.
This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause.
Women that want to take part in the study 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. Before the women are assigned a treatment, they will record information about their hot flashes.
Women will either take a lower or higher dose of 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 2 tablets of the study medicine (lower or higher dose of fezolinetant, or the placebo) once a day for up to 12 weeks. They will either take 1 tablet of fezolinetant (higher or lower dose) and 1 placebo tablet, or they will take 2 placebo tablets. The women will continue to record information about their hot flashes on the electronic device or their smartphone.
During the study, the women will visit the study clinic a few times. At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life. Other checks will include a medical examination, vital signs (temperature, blood pressure and pulse). Some blood and urine samples will be taken for laboratory tests. At some visits, the women will also have an ECG to check their heart rhythm. 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 tablets of the study medicine (1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet, or 2 placebo tablets).

开始日期2024-02-16

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）

2024-01-01·Menopause (New York, N.Y.)

Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause

Review

作者: Kagan, Risa ; Siddiqui, Emad ; Gao, Emily ; Ajmera, Mayank ; Zhao, Angela ; Morga, Antonia ; Patterson-Lomba, Oscar ; Mancuso, Shayna

Abstract:

Importance:

The neurokinin 3 receptor antagonist fezolinetant 45 mg/d significantly reduced frequency/severity of moderate to severe vasomotor symptoms (VMS) of menopause compared with placebo in two phase 3 randomized controlled trials. Its efficacy relative to available therapies is unknown.

Objective:

We conducted a systematic review and Bayesian network meta-analysis to compare efficacy with fezolinetant 45 mg and hormone therapy (HT) and non-HT for VMS in postmenopausal women.

Evidence Review:

Using OvidSP, we systematically searched multiple databases for phase 3 or 4 randomized controlled trials in postmenopausal women with ≥7 moderate to severe VMS per day or ≥50 VMS per week published/presented in English through June 25, 2021. Mean change in frequency and severity of moderate to severe VMS from baseline to week 12 and proportion of women with ≥75% reduction in VMS frequency at week 12 were assessed using fixed-effect models.

Findings:

The network meta-analysis included data from the pooled phase 3 fezolinetant trials plus 23 comparator publications across the outcomes analyzed (frequency, 19 [34 regimens]; severity, 6 [7 regimens]; ≥75% response, 9 [15 regimens]). Changes in VMS frequency did not differ significantly between fezolinetant 45 mg and any of the 27 HT regimens studied. Fezolinetant 45 mg reduced the frequency of moderate to severe VMS events per day significantly more than all non-HTs evaluated: paroxetine 7.5 mg (mean difference [95% credible interval {CrI}], 1.66 [0.63-2.71]), desvenlafaxine 50 to 200 mg (mean differences [95% CrI], 1.12 [0.10-2.13] to 2.16 [0.90-3.40]), and gabapentin ER 1800 mg (mean difference [95% CrI], 1.63 [0.48-2.81]), and significantly more than placebo (mean difference, 2.78 [95% CrI], 1.93-3.62]). Tibolone 2.5 mg (the only HT regimen evaluable for severity) significantly reduced VMS severity compared with fezolinetant 45 mg. Fezolinetant 45 mg significantly reduced VMS severity compared with desvenlafaxine 50 mg and placebo and did not differ significantly from higher desvenlafaxine doses or gabapentin ER 1800 mg. For ≥75% responder rates, fezolinetant 45 mg was less effective than tibolone 2.5 mg (not available in the United States) and conjugated estrogens 0.625 mg/bazedoxifene 20 mg (available only as 0.45 mg/20 mg in the United States), did not differ significantly from other non-HT regimens studied and was superior to desvenlafaxine 50 mg and placebo.

Conclusions:

The only HT regimens that showed significantly greater efficacy than fezolinetant 45 mg on any of the outcomes analyzed are not available in the United States. Fezolinetant 45 mg once daily was statistically significantly more effective than other non-HTs in reducing the frequency of moderate to severe VMS.

Relevance:

These findings may inform decision making with regard to the individualized management of bothersome VMS due to menopause.

2023-12-15·Medicine

Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis

Review

作者: Jaffar, Huda ; Bhattarai, Pratik ; Rahman, Ummi Aiman ; Hasanain, Muhammad ; Kashif, Talha Bin ; Rana, Maham ; Usman, Muhammad ; Cheema, Huzaifa Ahmad ; Anjum, Muhammad Umair

Background::

Menopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile.

Objective::

To review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile.

Methods::

A thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant.

Results::

There was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, −2.36; 95% confidence interval [CI], −2.85 to −1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90–1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group.

Discussion and implications::

Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.

2023-12-01·The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians

Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms

Review

作者: Onge, Erin St. ; Phillips, Bradley ; Miller, Lisa

Objective: To review the safety, efficacy, and tolerability of fezolinetant for the treatment of vasomotor symptoms associated with menopause. Data Sources: A literature search was conducted through PubMed using the following search terms: fezolinetant, ES259564, SKYLIGHT, vasomotor symptoms, and menopause. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of fezolinetant. Data Synthesis: Fezolinetant works by inhibiting neurokinin B from binding to its receptor in the hypothalamus, thereby decreasing the occurrence of vasomotor symptoms. Clinical trials have demonstrated fezolinetant is superior to placebo in decreasing the frequency and severity of vasomotor symptoms. Common adverse effects associated with the use of fezolinetant include headache and gastrointestinal disturbances, as well as elevations in liver transaminase levels. Conclusions: Clinical practice guidelines for the treatment of vasomotor symptoms associated with menopause recommend hormone therapy as the most effective treatment option. Risks associated with hormone use may limit the use of this option in some patients. Neurokinin B inhibitors, like fezolinetant, target the physiologic cause of vasomotor symptoms. With the approval of fezolinetant, as well as elinzanetant which is currently in phase 3 clinical trials, providers and patients have additional nonhormonal treatment options for vasomotor symptoms associated with menopause.

141

项与非唑奈坦相关的新闻（医药）

2024-06-05

·医药观澜

治疗女性更年期潮热，安斯泰来新药落地海南博鳌乐城

▎药明康德内容团队报道 6月3日消息，海南博鳌乐城国际医疗旅游先行区与安斯泰来（Astellas）中国共同宣布，治疗绝经相关中度至重度血管舒缩症状的非激素、选择性神经激肽3（NK3）受体拮抗剂药物fezolinetant正式获批落地博鳌乐城，有望为绝经相关潮热、盗汗患者带来非激素治疗的新选择。Fezolinetant已于去年获得美国FDA批准，根据FDA此前新闻稿，这是其批准的首款用于治疗女性更年期中重度潮热的NK3受体拮抗剂。绝经期是女性生命中正常、自然的变化，通常发生在45~55岁之间。血管舒缩症（VMS，又称潮热和/或盗汗）是绝经期女性中最常见的主诉之一，潮热从头部、颈部、胸部和上背部突然发作，皮肤红润，温度升高，全身热感。这些症状通常持续1~5分钟，随后可能出现寒战、湿冷、焦虑甚至偶发心悸的症状。中度至重度血管舒缩症状患者可还能出现睡眠问题、疲乏、焦虑和抑郁等，这些症状可能影响其日常活动和工作能力。据文献数据报道，中国女性生殖衰老队列研究发现围绝经期女性中受到这一问题困扰的比例高达80%，其中出现中重度症状比例超过50%。此外，中国女性出现VMS持续时间中位数为4.5年，这对女性健康、生活质量都带来潜在影响[3~5]。 Fezolinetant可阻断神经激肽B（NKB）与kisspeptin/神经激肽B/强啡肽（KNDy）神经元结合，从而调节体温调节中枢的神经元活动，降低绝经相关VMS的发生频率和严重程度。该产品此前已相继于2023年5月和12月在美国和欧洲获批，用于治疗绝经相关的中度至重度血管舒缩症状。据安斯泰来新闻稿介绍，fezolinetant已通过三项全球3期临床研究确定了其疗效和安全性，研究均达到所有主要疗效终点。治疗后第4和12周时，45mg组中度至重度VMS发生频率和严重程度较基线的降幅在统计学上显著优于安慰剂组，同时验证了45mg组治疗52周后总体安全性良好。安斯泰来中国区总裁赵萍女士表示，目前中国大众对于绝经管理的重视度已显著提升，越来越多的绝经期女性希望能得到更好的生活质量。绝经综合症包括盗汗潮热给女性的身体和生活带来了许多困扰，目前激素治疗可以帮助患者解决所有绝经相关问题的治疗方式，但由于适用人群的限制和可能出现的安全性问题，激素治疗的使用率目前还很低。许多绝经期女性没有得到最佳的治疗。Fezolinetant在乐城先行区的先行先试，将让中国女性使用到全新作用机制的非激素治疗药物，改善绝经期女性盗汗、潮热的问题，重获美好生活。参考资料： [1]血管舒缩症非激素治疗新选择——安斯泰来全球创新药物Fezolinetant落地博鳌乐城. Retrieved June 4, 2024, from https://mp.weixin.qq.com/s/phZy3IQ0ouZm2EHVLjnPaw [2]FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. Retrieved May 12， 2023, from https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause [3]Gold EB, Colvin A, Avis N, et al.. Am J Public Health. 2006;96:1226-35. [4]Stearns V et al. Lancet. 2002 Dec 7;360(9348):1851-61. [5]Li J, et al. Climacteric. 2020. 23(1): 46-52 . 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期临床结果

2024-05-18

·精准药物

拜耳裁员超千人

当拜耳1月公布重组计划时，只是预告要削减很多管理者岗位，并未给定具体数字。不过现在公众知道了，Bill Anderson这位新任CEO是认真的。拜耳本周举行了2024年第一季度财报电话会。Anderson透露，过去三个月，拜耳裁员1500人，其中约三分之二是管理者。该消息篇幅不大，却仍引起市场的特别关注。这似乎意味着，一个新的拜耳正一点点落地。去年，成立160年之际，这家巨头遭遇了重大挑战。除草剂Roundup官司不断，加上最重要的心血管药物之一asundexian的III期临床终止，拜耳股价一度跌回2009年的水平。平心而论，这种波动模型并不罕见，高风险的药物研发行业，不少时候都是法律纠纷与失败的代名词。问题是，对于拜耳来说，此番受挫成为压垮骆驼的最后一根稻草，积攒的矛盾通过该公司有史以来的单日最大跌幅爆发。被视为“救火队长”的Anderson，毫不留情地批评，拜耳年收入接近500亿欧元，现金流却几乎为0。他将这个责任算到叠床架屋的制度上，约12层公司管理岗位，令任何创新都举步维艰。2024年的动作预示着不一样的开始。电话会上，Anderson特别回应了DSO（dynamic shared ownership，动态共享所有权）框架。简单理解，拜耳希望将具体事项的决策权下放到员工手中。根据这位负责人的说法，经此调整，一个产前维生素组将项目时间从计划的21个月压缩至7个月。重组可以在多大程度上挽救巨头，接下来的时间段至关重要。拜耳正忙于推出新的产品增加收入，例如日前公布III期临床数据、行将上市的elinzanetant，而种种迹象表明，这场以创新为导向的裁员行动还没有到头。1“去老板”化，让近10万员工自主一个直接的疑惑是，拜耳会裁掉多少人？截至3月底，拜耳员工总数不足9.82万人，同比下降3.5%。援引一些媒体的报道，过去27年来，拜耳还没有进行过基于经营这类原因的裁员。在业务重组维度，拜耳上一次大规模调整发生在2018年底，削减了约1.2万个岗位。而如今由Anderson主导、持续到2025年的运动，并不设置固定上限，只是对外透露裁员的“重大意义”。第一季度裁掉1500个工作岗位，共花费了拜耳2亿欧元。但通过精简的公司结构，清理阻碍组织更快发展的角色，拜耳试图在2024年节省5亿欧元的成本。从2026年起，这些措施有望每年为这家巨头节省20亿欧元的运营开支。Anderson认为，扁平化等级制度和削减公司官僚主义，将是扭转局面的关键。“我们从一开始就说过，我们的重点并不在于人数的多少。我们的重点是不遗余力地确保公司的每项工作都以使命为导向。”Anderson在5月14日电话会上如是回应。显然，这与典型的业务重组不同。一般来说，药企管理层会决定裁员规模，再将目标分配到各个业务部门。拜耳却走上另一条道路，降本增效成为它的指南。由于采取类似“现收现付”的方式——核心着眼于行动时的成本控制——如果拜耳决定剥离或关闭一项大型业务，裁员的数量也随之陡增。3月Bill Anderson在金融新闻发布会上，就重点谈及精简机构人员接受Fortune采访时，拜耳一位发言人称，此次重组受影响的人数将数以千计。而据The Wall Street Journal报道，仅在拜耳美国制药部门，就有40%的管理职位面临下岗。“我们彻底的重塑将解放我们的员工。”Anderson如是展望。这位过去帮助基因泰克、罗氏获得创新增长的职业经理人，如今给拜耳开出了一种更加革命性的方子：公司正在走向“去老板”化，未来几年，员工队伍将由不断发展的“5000至6000个自主团队”组成，他们将在90天的时间里共同完成自己选择的项目，然后重新组合进行下一个项目。上述激进改变的一个触发点，是去年6月。Anderson走马上任后，了解到拜耳的规则和程序手册比《战争与和平》还要长。目前，拜耳消费者健康部门已在实践新的工作方法论。过去大半年，Anderson走访了拜耳在15个国家的团队，他表示，员工对DSO框架的反馈大多是积极的。减少官僚作风的同时，拜耳面向客户的自主团队数量在五个月内增加了10倍以上。到2024年底，拜耳全球的各个业务都将开始在这种模式下运作。制药部门现形成180个自主团队，大约70个位于美国。改革者Anderson对DSO寄予厚望。他强调，成本降低只是其中一项成果，最终，这个新模式将通过改善客户关系和加速创新来推动拜耳的持续增长，例如加强制药业务。3月，拜耳对制药部门进行了重塑。美洲商业运营主管Sebastian Guth，出任拜耳COO。此前负责肿瘤业务的Christine Roth，则领导一个全球商业化集团，后者将整合包括肿瘤、营销和医疗事务在内的部门。总体而言，此次变动后，拜耳的制药部门领导成员从14人减少到8人。2“药企”拜耳，一个缓慢的转身今年第一季度，拜耳累计销售额为138亿欧元，即使经过汇率和投资组合调整，该数据仍略低于同期。现金流方面，-26亿欧元已是增长36%的结果。纵观拜耳的三大业务，势头表现唯一“能打”的仅有制药部门，其中，又以前列腺癌药物Nubeqa和慢性肾病药物Kerendia的增长份额贡献最大——前者同比增长66%，后者则有64%。但要论绝对值，最高也不过3亿欧元。在此，“药企”拜耳的尴尬又一次被凸显。2024年第一季度拜耳制药部门产品营收表现作为多元化时代的产物，拜耳跟其他MNC类似，都曾是多元化战略的拥趸。虽然随着生命科学的发展，世纪之初，拜耳已剥离掉盈利不佳的材料科学等业务，但今天却仍保留着作物科学、消费者健康与制药业务并立的格局。所谓业务聚焦，已成为制药行业共识。诸如辉瑞等巨头，朝着成为纯药企而努力，拥抱一个高值市场。Anderson掌舵后，拜耳曾传出拆分的消息。可大半年过去，该计划尚未取得实质进展。公布2023年度财报时，Anderson将拜耳未来两三年的重点事项，划定在四个重点领域：建立强大的药品管道、解决诉讼、减少债务，以及继续推动DSO运营模式。他表示，自那以来的两个月，取得的改变已然值得宽慰。这些情况，暗示拆分工作缺乏可期的节点。Anderson介绍，在第一季度，公司如愿取得关于更年期延缓药物elinzanetant新的III期临床顶线结果。按照5月16日对外披露的数据，该药不仅优于安慰剂，也足以跟美国市场由安斯泰来开发的竞品Veozah一较高下。加上此前的积极数据，拜耳正着手向FDA递交这款“潜在重磅炸弹”的上市申请。“这是一个令人兴奋的机会。”Anderson不无激动地形容。合作伙伴已于1月向EMA递交了该药的上市申请，FDA也为相关申请设定了审批日期（2024年11月29日）。拜耳准备在明年推出该重要产品。另外，去年11月受挫的心血管在研管线asundexian并未一蹶不振。事实上，无论是从手中可打出的牌，抑或前期的投入成本出发，拜耳都不会轻易放弃。业内人士指出，asundexian是拜耳最有希望的资产之一，“没有它，制药部门就没有可持续的增长”。2024年度制药媒体日上，拜耳称，asundexian用于卒中二级预防的OCEANIC III期试验进展迅速。决定其命运的数据，最快可在2025年10月得出。拜耳截至2024年第一季度的制药管线展望眼下，积极的一面是，重组中的拜耳逐渐理顺了制药业务的发力赛道（心血管疾病、肿瘤学、免疫学、神经病学和罕见疾病），DSO代表的决策权下放，也让其能更加灵活地把握CGT等竞争激烈的技术机会。可回过头来看，这仍然是“远水”——远水解不了近渴。正因如此，当拜耳制药部门研发主管Christian Rommel扬言，“自2020年以来，拜耳已投资超过35亿欧元建立技术平台”，并且对“取得的关键进展感到兴奋”，背后的作用，跟该公司制药部门CEO Stefan Oelrich无惧罗氏竞品对重磅产品Eylea冲击的表态相似，更多为了增加外界的信心罢了。撑起拜耳制药部门半边天的Eylea、Xarelto，同样逃不开专利悬崖。而要完成新老药品的交棒，建立“够看”的管线矩阵，组织上的精简只是第一步，这家巨头显然还有长路得走。参考资料：（上下滑动查看更多）1.Bayer Q1 Media Update；Bayer2.Bayer AG (BAYZF) Q1 2024 Earnings Call Transcript；Seeking Alpha3.Bayer details layoffs as company shake-up continues；BioPharma Dive4.Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts；Fierce Pharma5.Pharmaceutical giant Bayer is getting rid of bosses and asking nearly 100,000 workers to ‘self-organize’ to save $2.15 billion；Fortune6.Bayer aims to enhance performance and regain strategic flexibility by 2026 – adjusted guidance for 2023 achieved；Bayer7.Bayer Pharmaceuticals advances next generation of blockbuster medicines；Bayer8.Unlike Regeneron, Bayer doesn't feel as much of a pinch from Roche's Vabysmo；Fierce Pharma9.Detailed trial data show Bayer drug alleviates menopause symptoms；BioPharma Dive声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床3期财报高管变更引进/卖出

2024-05-17

·同写意

千人被裁：拜耳向管理层挥出第一刀

同写意20岁庆！第五届全球生物医药前沿技术大会报名开启！“意”同创新，穿越周期。7月中旬，苏州金鸡湖畔，让我们与“新药写意人”一起为中国医药创新“同写意”！当拜耳1月公布重组计划时，只是预告要削减很多管理者岗位，并未给定具体数字。不过现在公众知道了，Bill Anderson这位新任CEO是认真的。拜耳本周举行了2024年第一季度财报电话会。Anderson透露，过去三个月，拜耳裁员1500人，其中约三分之二是管理者。该消息篇幅不大，却仍引起市场的特别关注。这似乎意味着，一个新的拜耳正一点点落地。去年，成立160年之际，这家巨头遭遇了重大挑战。除草剂Roundup官司不断，加上最重要的心血管药物之一asundexian的III期临床终止，拜耳股价一度跌回2009年的水平。平心而论，这种波动模型并不罕见，高风险的药物研发行业，不少时候都是法律纠纷与失败的代名词。问题是，对于拜耳来说，此番受挫成为压垮骆驼的最后一根稻草，积攒的矛盾通过该公司有史以来的单日最大跌幅爆发。被视为“救火队长”的Anderson，毫不留情地批评，拜耳年收入接近500亿欧元，现金流却几乎为0。他将这个责任算到叠床架屋的制度上，约12层公司管理岗位，令任何创新都举步维艰。2024年的动作预示着不一样的开始。电话会上，Anderson特别回应了DSO（dynamic shared ownership，动态共享所有权）框架。简单理解，拜耳希望将具体事项的决策权下放到员工手中。根据这位负责人的说法，经此调整，一个产前维生素组将项目时间从计划的21个月压缩至7个月。重组可以在多大程度上挽救巨头，接下来的时间段至关重要。拜耳正忙于推出新的产品增加收入，例如日前公布III期临床数据、行将上市的elinzanetant，而种种迹象表明，这场以创新为导向的裁员行动还没有到头。1“去老板”化，让近10万员工自主一个直接的疑惑是，拜耳会裁掉多少人？截至3月底，拜耳员工总数不足9.82万人，同比下降3.5%。援引一些媒体的报道，过去27年来，拜耳还没有进行过基于经营这类原因的裁员。在业务重组维度，拜耳上一次大规模调整发生在2018年底，削减了约1.2万个岗位。而如今由Anderson主导、持续到2025年的运动，并不设置固定上限，只是对外透露裁员的“重大意义”。第一季度裁掉1500个工作岗位，共花费了拜耳2亿欧元。但通过精简的公司结构，清理阻碍组织更快发展的角色，拜耳试图在2024年节省5亿欧元的成本。从2026年起，这些措施有望每年为这家巨头节省20亿欧元的运营开支。Anderson认为，扁平化等级制度和削减公司官僚主义，将是扭转局面的关键。“我们从一开始就说过，我们的重点并不在于人数的多少。我们的重点是不遗余力地确保公司的每项工作都以使命为导向。”Anderson在5月14日电话会上如是回应。显然，这与典型的业务重组不同。一般来说，药企管理层会决定裁员规模，再将目标分配到各个业务部门。拜耳却走上另一条道路，降本增效成为它的指南。由于采取类似“现收现付”的方式——核心着眼于行动时的成本控制——如果拜耳决定剥离或关闭一项大型业务，裁员的数量也随之陡增。3月Bill Anderson在金融新闻发布会上，就重点谈及精简机构人员接受Fortune采访时，拜耳一位发言人称，此次重组受影响的人数将数以千计。而据The Wall Street Journal报道，仅在拜耳美国制药部门，就有40%的管理职位面临下岗。“我们彻底的重塑将解放我们的员工。”Anderson如是展望。这位过去帮助基因泰克、罗氏获得创新增长的职业经理人，如今给拜耳开出了一种更加革命性的方子：公司正在走向“去老板”化，未来几年，员工队伍将由不断发展的“5000至6000个自主团队”组成，他们将在90天的时间里共同完成自己选择的项目，然后重新组合进行下一个项目。上述激进改变的一个触发点，是去年6月。Anderson走马上任后，了解到拜耳的规则和程序手册比《战争与和平》还要长。目前，拜耳消费者健康部门已在实践新的工作方法论。过去大半年，Anderson走访了拜耳在15个国家的团队，他表示，员工对DSO框架的反馈大多是积极的。减少官僚作风的同时，拜耳面向客户的自主团队数量在五个月内增加了10倍以上。到2024年底，拜耳全球的各个业务都将开始在这种模式下运作。制药部门现形成180个自主团队，大约70个位于美国。改革者Anderson对DSO寄予厚望。他强调，成本降低只是其中一项成果，最终，这个新模式将通过改善客户关系和加速创新来推动拜耳的持续增长，例如加强制药业务。3月，拜耳对制药部门进行了重塑。美洲商业运营主管Sebastian Guth，出任拜耳COO。此前负责肿瘤业务的Christine Roth，则领导一个全球商业化集团，后者将整合包括肿瘤、营销和医疗事务在内的部门。总体而言，此次变动后，拜耳的制药部门领导成员从14人减少到8人。2“药企”拜耳，一个缓慢的转身今年第一季度，拜耳累计销售额为138亿欧元，即使经过汇率和投资组合调整，该数据仍略低于同期。现金流方面，-26亿欧元已是增长36%的结果。纵观拜耳的三大业务，势头表现唯一“能打”的仅有制药部门，其中，又以前列腺癌药物Nubeqa和慢性肾病药物Kerendia的增长份额贡献最大——前者同比增长66%，后者则有64%。但要论绝对值，最高也不过3亿欧元。在此，“药企”拜耳的尴尬又一次被凸显。2024年第一季度拜耳制药部门产品营收表现作为多元化时代的产物，拜耳跟其他MNC类似，都曾是多元化战略的拥趸。虽然随着生命科学的发展，世纪之初，拜耳已剥离掉盈利不佳的材料科学等业务，但今天却仍保留着作物科学、消费者健康与制药业务并立的格局。所谓业务聚焦，已成为制药行业共识。诸如辉瑞等巨头，朝着成为纯药企而努力，拥抱一个高值市场。Anderson掌舵后，拜耳曾传出拆分的消息。可大半年过去，该计划尚未取得实质进展。公布2023年度财报时，Anderson将拜耳未来两三年的重点事项，划定在四个重点领域：建立强大的药品管道、解决诉讼、减少债务，以及继续推动DSO运营模式。他表示，自那以来的两个月，取得的改变已然值得宽慰。这些情况，暗示拆分工作缺乏可期的节点。Anderson介绍，在第一季度，公司如愿取得关于更年期延缓药物elinzanetant新的III期临床顶线结果。按照5月16日对外披露的数据，该药不仅优于安慰剂，也足以跟美国市场由安斯泰来开发的竞品Veozah一较高下。加上此前的积极数据，拜耳正着手向FDA递交这款“潜在重磅炸弹”的上市申请。“这是一个令人兴奋的机会。”Anderson不无激动地形容。合作伙伴已于1月向EMA递交了该药的上市申请，FDA也为相关申请设定了审批日期（2024年11月29日）。拜耳准备在明年推出该重要产品。另外，去年11月受挫的心血管在研管线asundexian并未一蹶不振。事实上，无论是从手中可打出的牌，抑或前期的投入成本出发，拜耳都不会轻易放弃。业内人士指出，asundexian是拜耳最有希望的资产之一，“没有它，制药部门就没有可持续的增长”。2024年度制药媒体日上，拜耳称，asundexian用于卒中二级预防的OCEANIC III期试验进展迅速。决定其命运的数据，最快可在2025年10月得出。拜耳截至2024年第一季度的制药管线展望眼下，积极的一面是，重组中的拜耳逐渐理顺了制药业务的发力赛道（心血管疾病、肿瘤学、免疫学、神经病学和罕见疾病），DSO代表的决策权下放，也让其能更加灵活地把握CGT等竞争激烈的技术机会。可回过头来看，这仍然是“远水”——远水解不了近渴。正因如此，当拜耳制药部门研发主管Christian Rommel扬言，“自2020年以来，拜耳已投资超过35亿欧元建立技术平台”，并且对“取得的关键进展感到兴奋”，背后的作用，跟该公司制药部门CEO Stefan Oelrich无惧罗氏竞品对重磅产品Eylea冲击的表态相似，更多为了增加外界的信心罢了。撑起拜耳制药部门半边天的Eylea、Xarelto，同样逃不开专利悬崖。而要完成新老药品的交棒，建立“够看”的管线矩阵，组织上的精简只是第一步，这家巨头显然还有长路得走。参考资料：（上下滑动查看更多）1.Bayer Q1 Media Update；Bayer2.Bayer AG (BAYZF) Q1 2024 Earnings Call Transcript；Seeking Alpha3.Bayer details layoffs as company shake-up continues；BioPharma Dive4.Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts；Fierce Pharma5.Pharmaceutical giant Bayer is getting rid of bosses and asking nearly 100,000 workers to ‘self-organize’ to save $2.15 billion；Fortune6.Bayer aims to enhance performance and regain strategic flexibility by 2026 – adjusted guidance for 2023 achieved；Bayer7.Bayer Pharmaceuticals advances next generation of blockbuster medicines；Bayer8.Unlike Regeneron, Bayer doesn't feel as much of a pinch from Roche's Vabysmo；Fierce Pharma9.Detailed trial data show Bayer drug alleviates menopause symptoms；BioPharma Dive更多优质内容，欢迎关注↓↓↓

财报临床3期高管变更

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	-	-	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,

后查看更多信息

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

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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


NCT05033886 (DAYLIGHT, Corporate Publications) 人工标引	临床3期	血管舒缩症	453	Fezolinetant	遞鏇膚遞網憲襯壓遞鹹(夢膚顧憲觸鏇窪蓋鹹製) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo 繭遞齋壓糧構鬱鹹獵壓 (廠選積憲淵艱築簾獵繭 ) 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)	夢壓鏇遞窪網鏇願簾繭(淵鹹窪獵鏇廠鹽鏇膚鬱) = 築鏇選選鏇淵艱夢範選網憲壓艱齋糧憲構顧襯 (艱廠艱顧鏇衊鹽鑰選築, 0.05) 更多	积极	2023-05-12
				Placebo (Trial 1)	夢壓鏇遞窪網鏇願簾繭(淵鹹窪獵鏇廠鹽鏇膚鬱) = 淵窪鑰糧築鏇範網鏇廠網憲壓艱齋糧憲構顧襯 (艱廠艱顧鏇衊鹽鑰選築, 0.05) 更多
NCT04003389 (SKYLIGHT 4, Pubmed)	临床3期	绝经期综合征	1,831	Fezolinetant 30 mg	製衊襯窪築構繭選鑰選(顧齋遞壓遞鹽糧製艱鹽) = 壓蓋構蓋繭蓋膚構鏇鑰鑰憲壓窪選鏇鹹鹹築顧 (鬱獵襯選淵醖願觸鬱觸 )	-	2023-03-09
				Fezolinetant 45 mg	壓憲築憲簾醖壓壓蓋遞(憲鏇構願繭窪簾醖廠選) = 鹹蓋蓋糧鏇鬱顧獵簾餘鑰窪構餘選鹽壓憲鏇襯 (獵憲衊壓構膚築廠夢築, 0 ~ 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	临床3期	血管舒缩症 \| 潮热	1,831	placebo (Placebo)	鏇壓築構鏇構衊艱鹹夢(繭築蓋廠範簾衊蓋觸衊) = 構網鏇鏇蓋壓築鑰觸鹹選獵獵範遞壓選觸鏇餘 (衊顧網遞鬱衊艱網積衊, 憲廠鑰獵膚鏇糧餘糧構 ~ 獵獵築製選遞簾糧壓襯) 更多	-	2023-02-01
				fezolinetant (Fezolinetant 30 mg)	鏇壓築構鏇構衊艱鹹夢(繭築蓋廠範簾衊蓋觸衊) = 觸簾艱積餘網範獵鏇壓選獵獵範遞壓選觸鏇餘 (衊顧網遞鬱衊艱網積衊, 願鹽願範網網獵構餘範 ~ 夢廠鏇廠積淵壓觸願膚) 更多
NCT04451226 (MOONLIGHT 3, PRNewswire) 人工标引	临床3期	血管舒缩症	150	Fezolinetant	簾鏇築顧艱簾獵艱願鹹(顧製觸餘選餘鏇簾鑰鹽) = generally consistent with previous Phase 3 studies of fezolinetant 築糧齋鏇膚選網範製糧 (築製艱艱選廠觸範齋獵 )	积极	2022-09-04
NCT04003155 (CTgov)	临床3期	潮热 \| 血管舒缩症	527	placebo (Double-blind Period: Placebo)	製衊製夢蓋淵範鬱繭網(構遞窪廠築襯觸膚範衊) = 選選築鏇選壓選築願築艱鹽網顧齋蓋鹹顧衊範 (糧顧衊餘襯鹹衊鏇襯鑰, 蓋憲憲願網觸窪衊觸積 ~ 醖繭衊衊製糧衊醖窪艱) 更多	-	2022-08-12
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	簾憲範願觸範範鬱構積(鹹糧夢簾壓夢觸遞遞範) = 壓鏇膚鏇願鬱顧窪糧襯範襯醖窪築醖醖淵窪積 (鬱膚顧齋網鹽餘願顧獵, 簾鏇艱顧糧遞選艱醖壓 ~ 膚觸範鬱積遞範鏇膚獵) 更多
NCT04003142 (CTgov)	临床3期	更年期综合症 \| 潮热 \| 血管舒缩症	501	placebo (Double-blind Period: Placebo)	願鹹選構獵糧顧遞蓋構(製鬱顧鏇壓壓鏇選繭積) = 範製餘構遞範膚蓋襯顧鑰襯艱壓網顧築獵糧觸 (遞鏇網鑰齋製鏇觸壓繭, 餘繭艱獵選齋憲糧齋壓 ~ 觸憲膚窪蓋夢夢淵顧繭) 更多	-	2022-06-15
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	鏇鏇繭蓋築廠顧鹽範鹽(選選鑰糧憲網夢夢網餘) = 繭醖醖製淵窪範範衊製窪衊壓獵窪範夢鑰範選 (淵蓋廠襯蓋鹹鹹鏇憲獵, 製顧觸齋糧構鏇繭繭顧 ~ 積選廠構憲襯膚夢鏇壓) 更多
NCT03192176 (Pubmed \| Menopause) 人工标引	临床2期	血管舒缩症	287	fezolinetant	鬱餘蓋廠廠鑰顧鹹願壓(願膚憲膚範襯齋選憲獵) = -1.9 to -3.5/day 顧製膚衊簾鹹齋糧獵網 (繭簾鑰膚願鑰觸網衊鹹 ) 更多	积极	2020-04-01
				Placebo