预约演示

更新于：2025-01-24

Estradiol

雌二醇

更新于：2025-01-24

概要

基本信息

简介雌二醇（E2）是雌激素家族的成员之一，它负责调节女性特征和月经-排卵周期。它在调节女性第二性征的发展中扮演了重要角色，如乳房生长、臀部扩张和特有的脂肪分布模式，同时也是乳房、子宫和阴道等女性生殖组织发育和维持的关键。除了这些重要功能外，E2在肝脏、骨骼、脂肪、皮肤和大脑等多种组织中产生显著影响。作为一种同时激活雌激素受体α和β亚型的激素，E2被认为是这些核类固醇激素受体的强效激动剂。该激素具有多种临床应用，如治疗绝经症状、预防绝经后骨质疏松症和治疗卵巢衰竭患者的低雌激素水平。此外，它还可用于治疗某些类型的乳腺和前列腺癌，突显了其多功能性和临床意义。E2可用于口服片剂、局部凝胶或贴片、阴道乳霜和注射等多种形式，这为个体根据其独特和特定的需求、偏好和医疗历史选择提供了丰富的选择。

药物类型

小分子化药

别名

17β-estradiol、17β-Oestradiol、E2

+ [71]

靶点

作用机制

ERs激动剂(雌激素受体家族激动剂)

治疗领域

心血管疾病内分泌与代谢疾病皮肤和肌肉骨骼疾病+ [2]

在研适应症

不孕卵巢刺激性交困难+ [11]

非在研适应症

晚期前列腺癌阿尔茨海默症瘢痕+ [10]

原研机构

Mylan NV

在研机构

Les Laboratoires Servier SASSandoz, Inc.Bayer HealthCare

+ [22]

非在研机构

Novo Nordisk A/S

Renovo Ltd.

AbbVie, Inc.

+ [12]

最高研发阶段批准上市

首次获批日期

美国 (1994-12-22),

低雌激素子宫出血血管舒缩症+ [1]

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C18H24O2

InChIKeyVOXZDWNPVJITMN-ZBRFXRBCSA-N

CAS号50-28-2

关联

458

项与雌二醇相关的临床试验

TCTR20170322001

/ Completed临床1期IIT

Effect of estradiol vaginal gel on vaginal atrophy in menopausal women: A randomized control trial

开始日期2560-07-05

申办/合作机构

Mahidol University

NCT06369363

/ Not yet recruiting早期临床1期IIT

Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines

To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor.

开始日期2025-09-01

申办/合作机构

Hershey Medical Center

NCT06780163

/ Not yet recruiting临床4期IIT

A Pre-Post Quasi-Experimental Study to Evaluate the Effects of Vaginal Estrogen on the Urine Microbiome and Overactive Bladder Symptoms in Menopausal Women

The goal of this Pre-Post Quasi-experimental study is to investigates the effect of vaginal estrogen therapy on changes in the urinary microbiome and its association with improvement in overactive bladder (OAB) symptoms in menopausal women
Primary Objective:
To evaluate the effects of vaginal estrogen on the level of Lactobacillus in the urine of postmenopausal women with OAB.
Secondary Objectives
1. To evaluate the effects of vaginal estrogen on urine microbiome in postmenopausal women with OAB.
2. To identify the association of alterations of urine microbiome after vaginal estrogen treatment with overactive bladder symptoms.
After informed and consents process, urine samples for microbiome study will be collected from participants with sterile technique. 17β-estradiol 10 mcg will be given to the participants. The participants will be ask to use 1 tab daily for 2 weeks vaginally before bed, then 1 tab twice a week vaginally before bed until 12 weeks. Then they will come back to hospital to take urine sample for microbiome study.

开始日期2025-03-01

申办/合作机构

Mahidol University

100 项与雌二醇相关的临床结果

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100 项与雌二醇相关的转化医学

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100 项与雌二醇相关的专利（医药）

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137,901

项与雌二醇相关的文献（医药）

2025-12-31·Journal of Maternal-Fetal & Neonatal Medicine

Cerebral vein thrombosis: management tactics with a focus on pregnancy, the use of hormone therapy and assisted reproductive technologies

Review

作者: Tretyakova, Maria ; Makatsariya, Alexander ; Tsibizova, Valentina ; Grigoreva, Kristina ; Zainulina, Marina ; Vorobev, Alexander ; Zubenko, Vladislav ; Gerotziafas, Grigoris ; Yagubova, Fidan ; Bitsadze, Viktoria ; Mashkova, Tamara ; Gris, Jean-Christophe ; Valikhanova, Lala ; Akinshina, Svetlana ; Makatsariya, Nataliya ; Elalamy, Ismail ; Kapanadze, Daredzhan ; Gashimova, Nilufar ; Khizroeva, Jamilya ; Solopova, Alina

Purpose: Cerebral vein thrombosis is a rare, life-threatening condition that has now become more commonly diagnosed due to advancements in imaging techniques. Our purpose is to improve understanding of pathogenesis, diagnosis and pregnancy and IVF management in patients with a history of cerebral thrombosis.Materials and methods: We present an overview of the modern tactics of anticoagulant therapy for cerebral thrombosis with a focus on pregnancy, the use of hormone therapy, and assisted reproductive technologies.Results: The most common risk factors for cerebral vein thrombosis are pregnancy, the postpartum period, and the use of oral contraceptives, which explains the high incidence of this pathology in women. The development of cerebral thrombosis is a vivid example of the interaction and synergetic effects of persistent factors that cause an increased risk of thrombotic complications, which include thrombophilia and acquired risk factors. Despite the possible risks, pregnancy after previously suffered cerebral thrombosis is not contraindicated provided adequate anticoagulant therapy.Conclusions: The most common provoking factors for the development of cerebral thrombosis in women are pregnancy and the use of estrogen-containing drugs. The issue of thromboprophylaxis during pregnancy, when using ART methods and the possibility of using hormonal therapy after cerebral vein thrombosis requires further study.

2025-12-31·Journal of the International Society of Sports Nutrition

Sex-specific impacts of caffeine on body composition: commentary on a retrospective cohort study

Article

作者: Mattioli, Anna Vittoria

BACKGROUND:

Understanding the impact of caffeine intake on body composition is a topic of growing research interest. The article "Association Between Caffeine Intake and Fat-Free Mass Index: A Retrospective Cohort Study" by Tian et al. explored this relationship, highlighting a positive correlation between caffeine consumption and fat-free mass index (FFMI). In this letter to the editor, we discuss the broader implications of these findings, emphasizing the need for further exploration of the underlying biological and lifestyle factors influencing caffeine's effects.

OBJECTIVE:

To provide critical insights into the mechanisms and contextual factors that may explain the observed association between caffeine intake and FFMI, with particular focus on sex-specific differences, hormonal influences, and lifestyle interactions.

METHODS:

This letter to editor builds on the findings of Tian et al., drawing from related literature and prior research to contextualize the potential mechanisms and broader implications of caffeine's impact on body composition. The discussion highlights key areas requiring further investigation, including the role of hormonal modulation, genetic variability, and long-term effects on muscle health.

DISCUSSION:

The positive association between caffeine intake and FFMI, particularly among women and younger populations, underscores the ergogenic potential of caffeine in enhancing muscle performance and metabolic efficiency. This letter expands on the study by emphasizing the role of hormonal factors, such as estrogen's modulation of CYP1A2, the liver enzyme critical for caffeine metabolism. The discussion also highlights the complex interplay between caffeine and other lifestyle factors. Finally, this commentary calls attention to the need for more research into the differential effects of caffeine sources, such as energy drinks and supplements, which often include additional ingredients with distinct metabolic and cardiovascular effects. These alternative sources may influence body composition differently than traditional coffee-based caffeine intake, an area that remains underexplored.

2025-12-01·JOURNAL OF MAMMARY GLAND BIOLOGY AND NEOPLASIA

Defective Mammary Epithelial Outgrowth in Transgenic EKAREV–NLS Mice: Correction via Estrogen Supplementation and Genetic Background Modification

Article

作者: Sumbalova Koledova, Zuzana ; Brezak, Matea

Fluorescent biosensors offer a powerful tool for tracking and quantifying protein activity in living systems with high temporospatial resolution. However, the expression of genetically encoded fluorescent proteins can interfere with endogenous signaling pathways, potentially leading to developmental and physiological abnormalities. The EKAREV-NLS mouse model, which carries a FRET-based biosensor for monitoring extracellular signal-regulated kinase (ERK) activity, has been widely utilized both in vivo and in vitro across various cell types and organs. In this study, we report a significant defect in mammary epithelial development in EKAREV-NLS C57BL/6J female mice. Our findings reveal that these mice exhibit severely impaired mammary epithelial outgrowth, linked to systemic defects including disrupted estrous cycling, impaired ovarian follicle maturation, anovulation, and reduced reproductive fitness. Notably, estrogen supplementation was sufficient to enhance mammary epithelial growth in the EKAREV-NLS C57BL/6J females. Furthermore, outcrossing to the ICR genetic background fully restored normal mammary epithelial outgrowth, indicating that the observed phenotype is dependent on genetic background. We also confirmed the functional performance of the biosensor in hormone-supplemented and outcrossed tissues through time-lapse imaging of primary mammary epithelial cells. Our results underscore the critical need for thorough characterization of biosensor-carrying models before their application in specific research contexts. Additionally, this work highlights the influence of hormonal and genetic factors on mammary gland development and emphasizes the importance of careful consideration when selecting biosensor strains for mammary studies.

375

项与雌二醇相关的新闻（医药）

2025-01-21

·drugs

Hormone Therapy Doesn't Increase Women's Risk of Brain Tumors

TUESDAY, Jan. 21, 2025 -- Hormone replacement therapy to ease menopause symptoms doesn’t increase a woman’s risk of brain tumors. Researchers found no link between hormone therapy and gliomas, the most common brain tumors in adults, according to results of a new study published recently in the journal Menopause . “Compared with nonusers, users of hormone therapy were not significantly associated with glioma risk,” a team led by senior researcher Dr. Hui Tang , a neurosurgeon with North Sichuan Medical College in Nanchong, China, wrote. No link was found even when researchers considered how long a woman had been taking hormone therapy, and whether she was currently using it. “Although there is a known sex difference in the incidence of gliomas, with women being six times more likely to develop the disease compared with men, there does not appear to be an association between glioma and hormone therapy use in postmenopausal women,” Dr. Stephanie Faubion , medical director for The Menopause Society, said in a news release. Hormone therapy is prescribed to treat common menopause symptoms like hot flashes, night sweats, mood swings and vaginal problems, researchers mentioned in background notes. The therapy had been widely used until 2002, when early clinical trial results showed an association between hormone therapy and increased risk of breast cancer, heart disease, stroke and blood clots. Since then, further study has shown that hormone therapy is indeed safe for treatment of menopause symptoms, but is unlikely to decrease risk for age-related health problems like heart disease or hip fractures. This new study set out to check one of the remaining concerns about hormone therapy and how it might increase risk of brain cancer in women. Some experts had speculated that women’s naturally higher risk of glioma might be linked to female hormones like estrogen. For this study, researchers analyzed data from more than 75,000 women between 50 and 78 years of age participating in a long-term cancer screening study. The women were tracked for an average 12 years. The results found that women using hormone therapy had no increased risk of gliomas, even if they’d been taking it for a while. But researchers said their findings should be verified in larger studies with more extended follow-up periods. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2025-01-10

·氨基观察

恒瑞医药PCSK9单抗获批；首付款900万美元，天广实APRIL抗体授权出海

氨基观察-创新药组原创出品作者 | 黄凯恒瑞医药PCSK9单抗登场。 1月10日，据NMPA官网，恒瑞医药PCSK9单抗瑞卡西获批上市，适用于：在控制饮食的基础上，与他汀类药物、或者与他汀类药物及其它降脂疗法联合用药，用于接受中等或以上剂量他汀类药物治疗仍无法达到低密度脂蛋白胆固醇目标的原发性高胆固醇血症和混合型血脂异常的成人患者；或单药用于非家族性高胆固醇血症和混合型血脂异常的成人患者。多款国产创新药出海。 1月10日，北京天广实生物宣布，天广实将授权Climb Bio使用处于临床前研发阶段的创新型APRIL抗体MIL116的相关专利和专有技术，并授权其在大中华区（包括中国内地、中国香港特别行政区、中国澳门特别行政区及台湾）以外的全球范围内开发、生产和销售的权利。该笔交易的首付款为900万美元，对于这笔交易你怎么看？同一日，首款国产BTK抑制剂出海。 1月10日，和正医药与中国科学院上海药物研究所共同宣布，与强生公司签订全球许可协议，开发潜在最佳的BTK降解剂HZ-Q1070，用于治疗多种疾病。另外，还有康诺亚的CD38单抗以NewCo模式授权出海。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）天广实APRIL抗体授权出海 1月10日，北京天广实生物宣布，天广实将授权Climb Bio使用处于临床前研发阶段的创新型APRIL抗体MIL116的相关专利和专有技术，并授权其在大中华区（包括中国内地、中国香港特别行政区、中国澳门特别行政区及台湾）以外的全球范围内开发、生产和销售的权利。该笔交易的首付款为900万美元。 2）和正医药/上海药物所BTK PROTAC授权强生 1月10日，和正医药与中国科学院上海药物研究所共同宣布，与强生公司签订全球许可协议，开发潜在最佳的BTK降解剂HZ-Q1070，用于治疗多种疾病。 3）康诺亚CD38单抗以NewCo模式授权出海 1月10日，康诺亚宣布，就潜在同类最优的靶向CD38人源化单克隆抗体CM313与Timberlyne Therapeutics达成独家授权许可协议。基于授权许可协议，康诺亚授予Timberlyne在全球（不包括中国内地、香港、澳门及台湾地区）开发、生产及商业化CM313的独家权益。作为回报，康诺亚将获得3000万美元首付款和近期付款，并获得Timberlyne股权，成为该公司最大股东。在达成若干销售及开发里程碑后，康诺亚可获得最多3.375亿美元的额外付款，及销售净额的分层特许权使用费。 4）再鼎医药与宜联生物达成战略合作 1月10日，宜联生物宣布，与再鼎医药达成一项新的战略合作和全球许可协议，后者将利用宜联生物医药的TMALIN®抗体偶联药物平台，开发一款针对实体瘤的新型LRRC15抗体偶联药物ZL-6201，该产品的抗体由再鼎医药内部发现。 / 02 / 资本信息 1）大博医疗2024年净利润同比预增493.50%–561.33% 1月10日，大博医疗发布2024年度业绩预告，预计归属于上市公司股东的净利润为盈利3.5亿元-3.9亿元，比上年同期增长493.50%-561.33%。 / 03 / 医药动态 1）百时美施贵宝BMS-986165片获临床许可 1月10日，据CDE官网，百时美施贵宝BMS-986165片获临床许可，拟用于儿童和青少年活动性幼年银屑病关节炎患者的治疗。 2）复宏汉霖注射用HLX43获临床许可 1月10日，据CDE官网，复宏汉霖注射用HLX43获临床许可，拟用于晚期/转移性实体瘤的研究。 3）中山主流源生物注射用MB0151获临床许可 1月10日，据CDE官网，中山主流源生物注射用MB0151获临床许可，拟用于晚期/转移性实体瘤的研究。 4）安进Tarlatamab获临床许可 1月10日，据CDE官网，安进Tarlatamab获临床许可，拟联合YL201联合或不联合抗PD-L1抑制剂治疗广泛期小细胞肺癌(SCLC)。 5）益科思特注射用YK012获临床许可 1月10日，据CDE官网，益科思特注射用YK012获临床许可，拟开展治疗中重度系统性红斑狼疮的研究。 6）环码生物HM2002注射液获临床许可 1月10日，据CDE官网，环码生物HM2002注射液获临床许可，拟开展治疗缺血性心脏病的研究。 7）石药DPP-4抑制剂普卢格列汀片获批上市 1月10日，据NMPA官网，石药集团DPP-4抑制剂普卢格列汀片获批上市，适用于改善成人2型糖尿病患者的血糖控制。 8）恒瑞医药PCSK9单抗获批上市 1月10日，据NMPA官网，恒瑞医药PCSK9单抗瑞卡西获批上市，在控制饮食的基础上，与他汀类药物、或者与他汀类药物及其它降脂疗法联合用药，用于接受中等或以上剂量他汀类药物治疗仍无法达到低密度脂蛋白胆固醇目标的原发性高胆固醇血症和混合型血脂异常的成人患者；或单药用于非家族性高胆固醇血症和混合型血脂异常的成人患者。 / 04 / 器械跟踪 1）亚辉龙取得两项医疗器械注册证 1月10日，亚辉龙公告，公司近日收到广东省药品监督管理局签发的两项医疗器械注册证，包括雌二醇（E2）测定试剂盒（化学发光法）和骨钙素测定试剂盒（化学发光法），注册证有效期至2030年1月7日。 / 06 / 海外药闻 1）首例！体内基因编辑插入整个基因，最低剂量就让患者完全缓解日前，iECURE公司报告了正在进行中的1/2期临床试验OTC-HOPE中的首例婴儿患者的初步研究结果，现实1名婴儿接受基因编辑疗法ECUR-506治疗后总体耐受性良好。在单次给药最低剂量的ECUR-506治疗后12周获得完全临床缓解。该患者停止使用氨清除药物，且每日平均蛋白质摄入量增加至符合年龄标准的水平。增加蛋白质摄入后患者耐受良好，平均氨水平保持在正常范围内，并较治疗前水平有所降低。该患者是首个通过基因编辑，在肝脏细胞的DNA中插入整个基因的婴儿，代表着体内基因编辑领域的重要里程碑。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

引进/卖出蛋白降解靶向嵌合体抗体药物偶联物

2025-01-09

·PipelineReview

Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of moderate to severe vasomotor symptoms caused by breast cancer treatments

In OASIS 4, a Phase III study conducted outside of the US, the investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy compared to placebo in women with or at high risk of developing hormone receptor positive breast cancer The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life The safety profile over 52 weeks is generally consistent with previously published data in postmenopausal women with VMS Positive topline results from OASIS 4, the first pivotal international Phase III study addressing this population of unmet medical need, add to the positive results of OASIS 1,2 and 3 and further support the efficacy and safety of elinzanetant Elinzanetant is the first dual neurokinin-1 and 3 (NK-1,3) receptor antagonist in development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy, administered orally once daily BERLIN, Germany I January 9, 2025 I Bayer today announced positive topline results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. 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. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. Elinzanetant also showed improvements of sleep disturbances and menopause-related quality of life at week 12 compared to placebo. The safety profile over 52 weeks observed in the OASIS 4 study is generally consistent with previously conducted studies and published data 1,2,3 on elinzanetant in postmenopausal women with VMS. “Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed the efficacy and safety for the treatment moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, Head of Research and Development and Member of the Executive Committee of Bayer’s Pharmaceuticals Division. “Importantly, OASIS 4 is the first pivotal international study to assess the safety and efficacy of a non-hormonal treatment approach for women with or at high risk of breast cancer who are suffering from VMS caused by adjuvant endocrine therapy, reaffirming our commitment at Bayer to advancing innovative treatments for the different needs of women and their health.” Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020, with nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen or aromatase inhibitors) for up to 10 years substantially reduces the breast cancer mortality rate throughout the 2 decades after diagnosis. 4 Adjuvant endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. VMS (also referred to as hot flashes) is a common adverse reaction of the adjuvant endocrine therapy, which may affect quality of life and treatment compliance, with potential impact on recurrence and long term outcomes 5 . There is unmet medical need for an effective non-hormonal treatment for VMS caused by adjuvant endocrine therapy as currently no approved treatment options are available. “For women undergoing endocrine therapy against breast cancer, menopausal symptoms like VMS and sleep disturbances are very common and can significantly affect quality of life, potentially impacting treatment adherence,” said Dr. Fatima Cardoso, Principal Investigator of OASIS 4, from Lisbon, Portugal. “The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.” Elinzanetant is the first dual neurokinin-1 and 3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer, administered orally once daily. OASIS 4 (NCT05030584) is the first pivotal international Phase III study to assess the safety and efficacy of a non-hormonal treatment of moderate to severe VMS caused by adjuvant endocrine therapy. It is the fourth Phase III study in the OASIS clinical development program with positive topline results, with details planned to be presented at upcoming scientific congresses. Data from OASIS 1 and 2 were published in the Journal of the American Medical Association ( JAMA ) 3 in August 2024. Detailed results of the Phase III study OASIS 3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world. About the Elinzanetant clinical development program The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS 4 is a double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and optionally for an additional 2 years in women with, or at high risk for developing hormone-receptor positive breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized. About Elinzanetant Elinzanetant is the first dual neurokinin-1 and 3 (NK-1, 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause. About Vasomotor Symptoms Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or adjuvant endocrine therapy. VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life. VMS may also be caused by adjuvant endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options. About Menopause 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 transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Menopausal symptoms can also be the result of surgical or medical treatment. Addressing the symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective. About Women’s Healthcare at Bayer 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. 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. 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. 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on LinkedIn: Bayer | Pharmaceuticals SOURCE: Bayer

临床3期临床结果

100 项与雌二醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00105	雌二醇	G03CA03	DB00783

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
不孕	日本	Fuji Pharma Co., Ltd.	2022-03-11
不孕	日本	Bayer Yakuhin Ltd.	2022-03-11
卵巢刺激	日本	Bayer Yakuhin Ltd.	2022-03-11
性交困难	美国	Mayne Pharma Ltd.	2018-05-29
雌激素缺乏症状	日本	Orion Corp.	2007-09-21
女性泌尿生殖器疾病	日本	Hisamitsu Pharmaceutical Co., Inc.	1999-10-01
潮热	日本	Hisamitsu Pharmaceutical Co., Inc.	1999-10-01
性腺机能减退	日本	Hisamitsu Pharmaceutical Co., Inc.	1999-10-01
萎缩性阴道炎	美国	Novo Nordisk, Inc.	1999-03-26
绝经期后骨质疏松	美国	AbbVie, Inc.	1996-12-20
泌尿生殖系统疾病	美国	Pfizer Inc.	1996-04-26
低雌激素	美国	Bayer HealthCare	1994-12-22
子宫出血	美国	Bayer HealthCare	1994-12-22
外阴和阴道萎缩	美国	Bayer HealthCare	1994-12-22
血管舒缩症	美国	Bayer HealthCare	1994-12-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
绝经后萎缩性阴道炎	临床3期	美国	Novo Nordisk A/S	2005-03-01
绝经后萎缩性阴道炎	临床3期	加拿大	Novo Nordisk A/S	2005-03-01
绝经期综合征	临床3期	奥地利	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	比利时	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	丹麦	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	芬兰	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	法国	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	德国	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	挪威	Novo Nordisk A/S	2004-05-28
绝经期综合征	临床3期	瑞典	Novo Nordisk A/S	2004-05-28

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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


SFN2024	N/A	雌激素缺乏症状	-	Estrogen (GDX+ES)	淵夢壓艱鬱繭範壓鹹鹽(醖膚簾蓋願淵壓築製餘) = 淵鬱廠糧襯蓋繭膚窪鹹願憲築築鑰顧積襯繭鑰 (夢淵夢齋網構製齋觸鏇 )	-	2024-10-07
				Estrogen (GDX+V)	淵夢壓艱鬱繭範壓鹹鹽(醖膚簾蓋願淵壓築製餘) = 獵衊鏇積鑰憲膚網衊鹽願憲築築鑰顧積襯繭鑰 (夢淵夢齋網構製齋觸鏇 )
SFN2024	N/A	-	-	estradiol (CRP levels)	糧構糧夢夢願網觸廠膚(鬱膚淵鏇築膚鬱範顧鑰) = 顧夢選衊遞獵網鹽繭餘壓糧艱鹽糧簾壓簾蓋鬱 (獵觸壓窪襯顧鏇製簾網, 4.46)	-	2024-10-07
ENDO2024	N/A	serum testosterone \| estrone \| sex hormone binding globulin	45	Subcutaneous Estradiol (SC E2)	簾製鬱顧糧壓顧顧醖鹹(製範窪獵醖繭齋鑰廠積) = There was one transient local reaction in the SC group 鑰鏇鹽鏇簾壓壓夢壓鑰 (廠鏇壓觸鏇觸餘簾廠鬱 ) 更多	-	2024-06-01
				Oral Estradiol (PO E2)
ENDO2024	N/A	Estrogen Receptors (ER) \| Progesterone Receptors (PR) \| Human Epidermal Growth Factor Receptor (HER2)	-	Estradiol (Stressed MDA-MB-231 cells)	製獵獵鬱鬱糧醖築衊獵(膚憲獵蓋鹽選憲築觸積) = 積膚鏇鏇選衊夢憲遞鬱憲鏇願夢鹽鹽遞願簾廠 (壓簾蓋網簾構範鏇鑰窪 )	-	2024-06-01
				Estradiol (MDA-MB-231 cells conditionally expressing AIPB)	製獵獵鬱鬱糧醖築衊獵(膚憲獵蓋鹽選憲築觸積) = 廠鹹衊遞艱網餘構繭膚憲鏇願夢鹽鹽遞願簾廠 (壓簾蓋網簾構範鏇鑰窪 )
ENDO2024	N/A	药物性肝损伤	-	Sublingual Estradiol 2 mg once daily	淵範簾憲齋鹽鹽簾鏇齋(餘醖憲獵簾餘築夢醖醖) = 憲積鹽獵齋顧範膚憲積鬱鏇壓獵構醖範衊選積 (糧獵艱選醖窪鹹願鏇積 ) 更多	-	2024-06-01
ENDO2024	N/A	Protein S	27	Standard Combined Oral (CO)	膚遞鬱積遞觸顧膚襯築(衊襯膚蓋選艱選餘餘窪) = 廠選築齋廠構選廠積窪獵製觸鏇鑰範鑰醖蓋憲 (鹹醖構壓鑰築衊鹽簾膚 )	积极	2024-06-01
				Sublingual Estradiol (SLE)	膚遞鬱積遞觸顧膚襯築(衊襯膚蓋選艱選餘餘窪) = 鹽膚糧選艱憲顧淵壓餘獵製觸鏇鑰範鑰醖蓋憲 (鹹醖構壓鑰築衊鹽簾膚 )
TREAT STUDY (ENDO2024)	N/A	testosterone \| estradiol \| estrone	-	Transdermal 17-beta estradiol	醖簾鏇鏇製範醖艱願憲(壓鏇壓廠簾醖衊簾鹽範): mean difference = -225.3 (95% CI, -28.8 ~ -421.7) 更多	积极	2024-06-01
				Once-daily sublingual 17-beta estradiol
ENDO2024	N/A	serum testosterone \| estrone \| sex hormone binding globulin	45	Subcutaneous Estradiol (SC E2)	憲築繭淵構選衊築鏇遞(觸齋憲襯鬱網膚醖鑰廠) = There was one transient local reaction in the SC group 鹽窪衊簾壓構製廠構艱 (鹽糧蓋製願窪鏇範築積 ) 更多	-	2024-06-01
				Oral Estradiol (PO E2)
ENDO2024	N/A	-	10	Estrogen Monotherapy	構膚蓋艱觸醖餘鬱壓艱(繭範憲醖艱衊壓壓窪獵) = 蓋製製窪憲廠廠窪鬱糧鹹膚築鬱願醖夢積衊獵 (繭鑰繭繭夢獵選餘鏇製 )	-	2024-06-01
NCT03332303 (CTgov)	临床3期	外阴和阴道萎缩	540	Estradiol Vaginal Cream (Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC))	築遞艱鏇餘窪築淵築簾(夢淵製鹹選衊蓋膚鹹窪) = 壓簾糧遞構衊鏇蓋膚鹽襯壓憲鏇餘窪鹽蓋膚淵 (淵鹽糧餘築廠艱繭觸憲, 觸窪襯衊鏇鑰艱製膚窪 ~ 願遞選衊衊鬱範顧糧選) 更多	-	2024-05-30
				Estrace® Cream (Active Comparator: Estrace® Cream)	築遞艱鏇餘窪築淵築簾(夢淵製鹹選衊蓋膚鹹窪) = 餘壓餘鏇選蓋願膚構鏇襯壓憲鏇餘窪鹽蓋膚淵 (淵鹽糧餘築廠艱繭觸憲, 積遞壓膚鬱築齋齋製網 ~ 艱夢網觸襯夢壓淵醖膚) 更多