更新于：2024-11-21

Levonorgestrel

左炔诺孕酮

更新于：2024-11-21

概要

概要

基本信息

药物类型

小分子化药

别名

(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one、(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one、13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one

+ [53]

靶点

作用机制

PR激动剂(孕激素受体激动剂)

治疗领域

泌尿生殖系统疾病其他疾病

在研适应症

月经紊乱月经过多避孕

非在研适应症

痛经出血绝经期综合征

原研机构

The Population Council, Inc.

在研机构

Daré Bioscience, Inc.

Bayer Yakuhin Ltd.

Bayer HealthCare Pharmaceuticals, Inc.

+ [4]

非在研机构

Bayer AG

The Population Council, Inc.Wyeth AB

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (1990-12-10),

避孕

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构

分子式C21H28O2

InChIKeyWWYNJERNGUHSAO-XUDSTZEESA-N

CAS号797-63-7

关联

235

项与左炔诺孕酮相关的临床试验

NCT04457076 / Not yet recruiting临床3期

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCept™, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability

To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept

开始日期2025-01-01

申办/合作机构

PRA Health Sciences, Inc.

NCT06577168 / Not yet recruitingN/AIIT

The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.

The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

开始日期2024-12-01

申办/合作机构

Assiut University

NCT06620939 / Not yet recruitingN/AIIT

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial

The goal of this clinical trial is to determine whether the LNG-IUS is more effective to that of expectant in preventing endometrial polyp recurrence after hysteroscopic polypectomy.
Researchers will compare LNG-IUS to expectant management to see if LNG-IUS works to reduce the recurrence rate of endometrial polyps.
Participants will:
Receive Mirena placement or not after hysteroscopic polypectomy； Be scheduled for a follow-up with TVCD to screen for endometrial polyps recurrence every 6 months.

开始日期2024-12-01

申办/合作机构

上海市第一人民医院

[+1]

100 项与左炔诺孕酮相关的临床结果

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100 项与左炔诺孕酮相关的转化医学

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100 项与左炔诺孕酮相关的专利（医药）

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6,123

项与左炔诺孕酮相关的文献（医药）

2024-12-01·Veterinary Parasitology

Levonorgestrel enhanced Toxoplasma gondii infection risk via progesterone receptor upregulation

Article

作者: Wang, Shenghui ; Sun, Tiancong ; Chen, Zhaoguo ; Zhang, Yan ; Mi, Rongsheng ; Gong, Haiyan ; Huang, Yan

The numerous stray cats and dogs worldwide pose a huge burden on local governments, keeping residents safe and healthy, and maintaining clean cities with good traffic situations. To effectively control the populations of these stray animals, while considering animal welfare, researchers have suggested the use of levonorgestrel (LNG) as a contraceptive method. However, the potential side effects of LNG on these animals need to be evaluated before widespread application. Since dogs and cats play important roles in the transmission of Toxoplasma gondii as intermediate and definitive hosts, respectively, it is critical to assess the safety of LNG from the perspective of its effect on Toxoplasma susceptibility. In this study, the susceptibility of mice to T. gondii infection was investigated in vivo and in vitro with the presence of LNG. As a result, LNG increased the risk of infection, which was probably associated with the downregulation of IFN-γ levels, but not with the alteration of host sex hormone levels. Concurrently, the presence of LNG enhanced the expression of its ligand, the progesterone receptor (PGR), on the host cells. The promotional effect of LNG on T. gondii infection was attenuated when the PGR gene was knocked down. This investigation represents the inaugural study of LNG's side effects on T. gondii infection in mice, underscoring the significance of choosing or developing suitable contraceptive drugs for stray animals.

2024-12-01·International Journal of Surgery Case Reports

Case report: Bladder stone caused by dislocated Cu-IUD

Article

作者: Piriyev, Elvin ; Suleymanov, Azad ; Ali Azim, Ahdab ; Jigarov, Gamzat ; Mukhtarov, Emil ; Azim, Ahdab Ali ; Römer, Thomas

INTRODUCTION AND IMPORTANCEThe intrauterine device, usually in the form of a copper IUD or levonorgestrel intrauterine system, is a widely used contraceptive method. The risk of uterine perforation is low and ranges from 0.3 to 2.2 per 1000 insertions for Cu-IUD. The bladder, with 24 %, is, after the bowel, the second most common location among all intra-abdominal locations of the migrated IUDs, which can cause development of a bladder stone.CASE PRESENTATIONWe present a case of a 32-year-old woman who attends with increasing dysuria. She reported using an IUD before her last pregnancy. Abdominal sonography and computed tomography revealed a lost IUD migrated into the bladder with stone formation. An open abdominal cystotomy was carried out in order to remove the IUD. Patient reported improvement of the symptoms postoperatively.CLINICAL DISCUSSIONIn the case of transvesical migration of IUD, lower urinary tract symptoms can occur and vesicolithiasis can develop. If the IUD is completely inside the bladder or if it gets small stones inside it, the device and stones may need to be removed through a cystoscopic or suprapubic approach. When large stones have formed or when the IUD has partially penetrated the bladder wall, open surgery has been the method of choice for removal.CONCLUSIONIn case of migrated IUD, a vaginal and abdominal ultrasound, X-rays, and computed tomography are useful tools for detecting dislocated IUDs. For the treatment physicians can choose a cystoscopic, laparoscopic, or abdominal approach based on the symptoms, the size of the stones, the IUD's location on the bladder wall, and their experience in laparoscopy and open surgery. If patients report dysuria after inserting of IUD a migrated IUD into the bladder should be taken into account.

2024-12-01·Environmental Research

Simultaneous removal of E1, E2, EE2 and levonorgestrel from water using TiO2 catalyst anchored on activated carbon: Processes optimization, materials characterization, and assessment of the estrogenicity reduction

Article

作者: Kuznetsov, Alexei ; Hoshima, Henrique Y ; Coutinho, Rodrigo ; Bila, Daniele M ; Pastre, Marina M.G. ; da Silva, Adriana M. ; da S Marques, Bruno ; Marques, Marcia ; Hoshima, Henrique Y. ; Bila, Daniele M. ; Pagliari, Bruna G. ; da Silva, Adriana M ; Pastre, Marina M G ; da S. Marques, Bruno ; Renno, Marina ; Pagliari, Bruna G

Removal of estrogen hormones from water matrices is crucial owing to its adverse effects on aquatic ecosystems and human health. The present investigation applies an advanced approach to assess the effectiveness of combined processes (adsorption and visible-light-driven photo-degradation) for simultaneous removal of estrone (E1), 17β-estradiol (E2), 17α-ethinylestradiol (EE2), and levonorgestrel (LEVO) in water, applying TiO₂-activated carbon composite selected through design of experiment (DoE) for process optimization. Based on a central composite rotatable design (CCRD), composites were synthesized with percentages of activated carbon (AC) ranging from 2.93% to 17.07% (wt.) and calcination temperatures between 259 and 541 °C. The composite with the best performance TiO₂-AC15%-541 (15% wt. AC, calcined at 541 °C), achieved a total removal of 98.3 ± 1.15% for E1, 99.0 ± 1% for E2, 99.3 ± 1.15% for EE2, and 96.0 ± 2.65% for LEVO at the initial concentration of 100 μg L^-1 under simulated solar irradiation. Further optimization using once more CCRD involved three independent variables: pH; hormone concentration/TiO₂-AC15%-541 loading ratio; and the intensity of simulated solar irradiation. Under optimized conditions (pH 2.64, hormone concentration/TiO₂-AC15%-541 loading ratio of 3.8 mg g^-1, and irradiation intensity of 41 W m^-2 UV-A), the TiO₂-AC15%-541 composite removed 99.8% of E1, 99.8% of E2, 99.0% of EE2, and 92.1% of LEVO. Furthermore, the process achieved a 99.9% reduction in estrogenic activity, assessed with yeast estrogen screen (YES) assay. These results demonstrate that TiO₂-AC15%-541 is an efficient and cost-effective remediation agent for treating mixed estrogen compounds in water, with significant potential for commercial applications.

185

项与左炔诺孕酮相关的新闻（医药）

2024-11-19

·赛柏蓝

行业下行，越来越多的药企寻求「退出」？

作者 | 陈芋编辑｜遥望来源 | 赛柏蓝行业下行期，企业退出意愿加强，头部药企加速收割市场，产业整合提速。 01 进入2024年接连有药企易主今年2月，华润双鹤以31亿元收购华润紫竹100%股权，通过紫竹旗下毓婷、金毓婷等核心产品丰富双鹤专科领域产品线，形成“女性健康+儿科”专科产品序列，完善产品矩阵； 3月，主营中成药业务的新天药业宣布拟通过发行股份收购汇伦医药85.12%的股权，将业务拓展至小分子化学药领域； 6月，国内对比剂龙头北陆药业以2.02亿元收购承德天原药业80%股权，扩大其在中成药领域的覆盖； 10月，新诺威（石药创新）收购石药百克方案出炉，新诺威将以高达76亿元的总价收购石药百克100%股权，以增强其生物医药平台的创新能力； 10月，华润双鹤又以2.6亿元自有资金收购贵州天安药业89.681%股权，进一步充实糖尿病药物产品线； 11月，“四大老牌制药企业”之一东北制药作价1.87亿元收购北京鼎成肽源70%股权，从TCR-T进军创新药。行业进入中低速增长存量博弈期，有企业退出意愿加剧，也有企业趁着标的估值合适大举收购。 02 行业低谷期整合需求强烈 11月18日，在由赛柏蓝承办的第44届中国医药产业发展高峰论坛上，南京医药股份有限公司副总裁彭玉萍表示，中国医药行业已从高速增长的增量博弈发展模式转变为中低速增长的存量博弈的发展模式，内生增长的投资回报率逐渐下降。据中国医药企业管理协会数据，2024年上半年，全国医药工业营收、利润双双下降，分别较上年同期下降了1.4%、1.2%，除中药饮片、药用辅料及包装材料、生物制品3个子行业外，化学制药、化学原料药、医疗仪器设备及器械、卫生材料及医药用品、中成药、制药专用设备6个子行业营收均下降。据东海证券报告，今年前三季度医药生物行业上市公司整体实现营业收入18141.57亿元，同比下降0.39%；归母净利润1450.40亿元，同比下降9.01%（共纳入A股申万医药生物行业432只个股作为分析样本）。同期医药生物上市公司盈利能力整体小幅下降——前三季度整体毛利率为32.06%，较去年同期下降0.88个百分点；净利率为8.45%，较去年同期下降0.78个百分点。资本市场方面，IPO大幅减少。自证监会2023年8月27日提出“阶段性收紧IPO节奏”后一年内，484家企业IPO终止，同比增加71.03%；新增IPO受理企业135家，同比下滑74.67%；329家公司排队在审，同比减少57.82%。同时，128家企业上市融资938.44亿元，数量、金额也分别同比下滑69.69%、80.03%。彭玉萍提到，行业整体增长缓慢甚至下降的压力下，产业链上下游之间的整合需求愈发强烈，部分医药企业主动发起产业并购，以此寻找“第二增长曲线”。一拍即合的买与卖之下是买方和卖方在行业下行期下并不相同的心态。面临营收、利润指标的压力时，手上有钱的大药企将收并购作为最快速的带来营收和利润的方式；而对于急于退出的药企及其背后的持股人来说，卖身在环境不好的时候成为了一个比坚持更容易的选择。政策支持也是重组并购的重要推动力。今年9月，证监会发布《关于深化上市公司并购重组市场改革的意见》，支持上市公司向新质生产力方向转型升级，鼓励上市公司加强产业整合，同时明确将提升重组市场交易效率等；10月，上交所召开券商座谈会，重点推动“并购六条”和“科创板八条”落地。随着市场环境变化和系列政策出台，当下的并购市场由“套利并购”逐渐回归到“产业并购”的轨道上，并购重组从市值导向到产业导向的转变在加快。 03 谨慎选择标的重视并购后管理加入南京医药前，彭玉萍在江苏高投、沿海资本等投资机构有着十余年的工作经验，她坦言，与一级市场投资相比，企业间的收并购更加复杂。战略导向下的产业并购重组交易不是两家公司间的资本游戏，而需要深刻的行业洞见与企业经营管理经验作支撑。一方面企业在展开收并购前首先要明确自身产业定位和方向，理性对待诸多“风口”，以提升主业核心竞争力为导向，注重远期收益，合理制定发展规划和并购节奏，避免盲目并购。其次，理解标的资产也是展开高质量收并购的前提，包括标的公司的商业模式、业务模式、资源组织模式等。同时，还需结合行业背景判断标的公司风险，例如其毛利率水平与行业地位是否匹配，是否存在背离行业的特殊情况，应收帐款、存货预付款、现金流净额等是否存在异常波动等。从更长的时间维度来看，企业展开收并购要循序渐进，对并购领域不熟悉的公司先从小额并购、现金并购做起，不盲目求大、求快，还可以引入分期收购等形式，根据业绩承诺完成以及整合情况决定是否收购剩余股份。另一方面，完成交易流程后的并购后管理更加重要，彭玉萍指出，双方需要展开“钱&人&文化”的全方位整合。在“钱”上，需要管理好银行账户、审批权限等；在“人”上，需要管理好法人、关键岗位、考核评价权等；在“文化”上，需要在价值取向上达成共识，通过对双方文化现状的准确把握确认文化融合的最佳方式。为实现并购重组价值最大化，企业需要逐步完成从股权、财务报表等浅层整合，向业务、团队、文化、管理、价值观等产业链各环节深度融合的升级。收购方可通过向标的企业注入资金、资源及管理经验提高其经营效率和盈利水平，标的公司并入后带来的横向或纵向扩张也将完善企业布局、提升规模效应，协同提升整体价值。 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

并购IPO

2024-11-15

·CPHI制药在线

这家药企几十年只做一种药，是为给女人改命

关注并星标CPHI制药在线今年，一席有个来自药企的演说，让很多人着实震撼了一把。演讲者是上海达华药业的副总，提到了一个特别让人感慨的话题，女性的生育权选择。乌干达有位女性，自从12岁结婚，到2016年时，她已经生了44个孩子，有38个活了下来。图源：一席公众号而上海达华药业的一款药，可能是终结这些女性不断孕育的救星，左炔诺孕酮硅胶棒（II），植入人体后，能长效的避孕。这款药在国内有两个文号，分别是上海达华药业和辽宁绿丹药业持有。图源：药监局人类的繁衍与避孕，一直是历史长河中同时并存的，在没有避孕设施的情况下，古罗马人一度把罗盘草作为避孕药，这种植物有生殖毒性，可以用来避孕以及堕胎。可能因为效果不错，作为一种北非利比亚的植物，甚至进入到一些国外的推理小说中。也有一些直接是用杜松子酒加泻盐，喝完后，坐在浴盆里加热水。为了避孕，真的开发过很多稀奇古怪的东西以及风俗。但直到避孕药和器械的商业化，才有了真正意义上的自我选择生育。国内外同类避孕药物，还是以口服药为主，毕竟在很多地区都有出售避孕器械，甚至还会免费发放。而且短期避孕药也有很多选择，还会分事前和事后型。像左炔诺孕酮片以及复方左炔诺孕酮片，国内有20个文号。被南京白敬宇制药、山东鑫惠药业、上海信谊天平药业、北京利龄恒泰药业、华润紫竹药业、北京亚东生物制药、南通联亚药业、东北制药、四川川大华西药业、北京法莫斯达制药、华中药业持有。尽管片剂有多个，但左炔诺孕酮胶囊，则只有武汉九珑人福药业注册。其他口服药还有分散片剂型、肠溶片和滴丸。秦皇岛紫竹药业，则有注册原料药。图源：药监局其他的事前避孕药，短效的有复方炔诺酮片、复方醋酸甲地孕酮片；长效注射避孕药有复方己酸羟孕酮注射液和复方甲地孕酮注射液等。其他的还有炔诺酮三相片等等，都是基于一个现实，不是论年作为时间单位用药的，得往复用药。这也是国内避孕药企业的一个经营模式，在物流以及药店医院便利的情况下，很多人感受不到压力。使用植入剂来避孕，对于我们来说属于“可以，但没必要”。而非洲这种地方，可是达不到用药便利的，频繁用药，也会有经济压力。因此，植入剂在这里有特有的优势。一次植入能长效发挥作用，是在这些国家得到广泛应用的原因。因地制宜，物质条件决定哪种方法更适合。国内增长快的避孕药中，紧急避孕销量增速很快，而且市场占比近七成，2022年紧急避孕药行业产能有4.46亿片。不过哪怕是现在紧急避孕药已经囊括口服、注射、贴剂、栓剂等多个类型，也很难在非洲这些区域发挥作用。这就是地域属性带来的市场划分，像左炔诺孕酮硅胶棒（II）植入后，持续缓释，有效期达3到4年，有效率高，相对成本低且安全。就是适合这个区域，你说是匠心独具也好，说是不忘初心也好，反正独特的经济与民生环境，适合这个独特的产品。如果没有这个药，怕是很多女性，还要面对不断孕育的困境。每次植入产生三到四年的避孕，相当于给她们逆天改命。当然如果这类产品针对的是国内市场，那可能销量未必乐观。也只有那个区域，买不起常规避孕药、用不上安全套，宫内节育器又比较考验医疗环境，再考虑到要有可逆性，机缘巧合之下，皮下植入剂反而最为实用。从一家只做国内业务的药企，成为可以跨国出口的企业，并非易事。第一步就是药品预认证以及WHO的现场检查，为了对应国外法规，再增加检测项目。而且国内药品出口，要面对的另一个问题就是临床试验数据和注册。不同的国家上市销售，必须要根据当地法规走流程。现在不同国家的临床试验很多都不是互认的，而且本身是一款老产品，当年的临床数据无法达到现在的要求。所以一款老药要实现出口，实现全球医疗，不是一件简单事，需要药企能不断的完善自己。一些药企可能在一个临床试验上，就栽了跟头，然后止步不前，再也不更新进度。从这看，药物实打实的有效，才是实现出口的基础。这家药企之前的销售状况并不好，本来濒临破产的药企，一年产个一二十万套。在跨国贸易后，反而迎来了新生，而且企业很有远见的拒绝了收购，很难得。毕竟有些收购，是排他性手段之一，不是为了让你继续生产，而是以收购来让你直接停产，转而高价销售自己的产品。这一点，很值得我们有特色产品的制药企业提高警惕。一个小小的植入剂，而且并非新产品，却很朴素地真正实现了为全球女性健康做出贡献这一愿景。可能还有很多药企，也正在默默做着类似的事，只不过我们没有机会去了解，也期待各位能谱写自己药企的故事。 END 【智药研习社线上研习会报名】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

医药出海

2024-11-07

·Business Wire

ViiV Healthcare expands on real-world data supporting use of long-acting therapies in diverse patient populations at HIV Glasgow

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will share new data from its industry-leading HIV treatment and prevention portfolio and pipeline at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November 2024. Spanning 42 abstracts, the data showcases long-acting and two-drug regimens as care options for diverse populations in the face of a continuing HIV epidemic. Harmony P. Garges, MD, Senior Vice President and Chief Medical Officer at ViiV Healthcare, said: “ViiV Healthcare is the first company to develop and launch long-acting options and two-drug regimens, and these therapies are transforming how physicians and providers treat and prevent HIV today. We continue evaluating how diverse populations living with or impacted by HIV respond to our therapies in the real world. Data from these studies include more than 10,000 people using Vocabria + Rekambys , more than 50,000 people using Dovato and more than 1,300 people using Apretude 1 . At HIV Glasgow, ViiV Healthcare is showcasing new, compelling data from our portfolio that reinforces how our medicines impact health outcomes and contribute to ending the HIV epidemic. ” Key data to be presented at HIV Glasgow 2024 by ViiV Healthcare and its study partners will include: Analysis of cabotegravir + rilpivirine long-acting (CAB+RPV LA) in the real-world and across phase 3/3b studies : Findings from a large-scale post hoc analysis of the complete long-acting HIV treatment regimen CAB+RPV LA will be presented. The analysis, which pooled data from over 2,500 participants across four major phase 3/3b clinical trials (FLAIR, ATLAS, ATLAS-2M, and SOLAR), will compare virologic outcomes and isolated viraemic events between daily oral HIV treatment and CAB+RPV LA. 2 Furthermore, the real-world utilisation of CAB+RPV LA will be explored in an analysis of adherence and persistence in a Canadian patient support program. These analyses will add to the growing body of clinical and real-world evidence for CAB+RPV LA and offer additional insights to healthcare providers on outcomes for CAB+RPV LA in diverse populations. Data exploring the use of dolutegravir/lamivudine (DTG/3TC) in antiretroviral-naïve people living with HIV: Findings will be presented from the Fundación Huésped-sponsored DOLCE study. This is the first study to fully focus on evaluating the efficacy and safety of the 2-drug regimen DTG/3TC in people living with HIV with CD4 ≤ 200 cells/mm³. 3 Additionally, data will be shared from the phase IV D2ARLING study, which compared the efficacy and safety of DTG/3TC against a 3-drug regimen in an antiretroviral-naïve population that did not have baseline drug-resistance testing results available. 4 Many guidelines recommend baseline drug resistance testing prior to antiretroviral therapy (ART) initiation, that may not always be readily accessible, reinforcing the need and impact of these data in an antiretroviral-naïve population. Cost-effectiveness and usage patterns for long-acting HIV prevention: Findings from a cost-effectiveness study examining the economic and public-health impact of cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in Canada will be presented. Researchers will compare the impact of the introduction of CAB LA for PrEP against daily oral PrEP (TDF/FTC) and no PrEP usage on cost savings and quality-adjusted life years. 5 New findings from the PROTECT survey will be shared, exploring differences in interest and intention to use long-acting PrEP among men who have sex with men and heterosexual men and women in 20 European countries. 6,7 Advancing novel mechanisms of action in HIV research: New findings from the BANNER study of VH3810109 (N6LS), an investigational, broadly neutralising antibody (bNAb), will be presented. Previously presented phase IIa proof-of-concept findings from the BANNER study suggested VH109 was well-tolerated and efficacious in people living with HIV. 8 Researchers will share new findings exploring the correlation between baseline phenotypic sensitivity to N6LS and virologic response after treatment with N6LS. 9 Additional research evaluating N6LS will focus on administration and dose responsiveness, adding to the growing body of evidence supporting the bNAb as a potential new approach to treating HIV. 10 ViiV Healthcare-sponsored or supported studies to be presented at HIV Glasgow 2024: Title First Author Presentation Cabotegravir + rilpivirine long-acting Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies J. Thornhill Poster Presentation Real-world utilization of cabotegravir/rilpivirine: an observational analysis of adherence and persistence using a patient support program in Canada, preliminary results C. LaForty Poster Presentation Feasibility and satisfaction of interventions measures (FIM and HIVTISQ) of implementation long-acting (LA) CAB+RPV administration out of HIV units: the IMADART study A. Cabello Poster Presentation Cabotegravir and rilpivirine concentrations and HIV-1 RNA suppression in male and female genital fluids and rectal tissue in people with HIV on antiretroviral therapy with long-acting intramuscular cabotegravir plus rilpivirine A. Fernández Oral Presentation Use of long-acting cabotegravir and rilpivirine in a real-life setting: 12-month results of virological outcome, adherence, safety, durability, in the ANRS CO3 AquiVIH-NA cohort-France M. Hessamfar Poster Presentation Results at month 7 of CABO-CHANCE study: real-world-evidence (RWE) on the use of intramuscular cabotegravir plus rilpivirine long-acting (CAB+RPV LA) dosed every 2 months in viral suppressed people with HIV (PWH) C. H. Tenorio Poster Presentation Re-suppression regimens and outcomes after virological failure in randomised controlled trials and real-world evidence studies evaluating cabotegravir and rilpivirine (CAB+RPV) A. Elias Poster Presentation Virological failure rate and emergent resistance in real-world studies evaluating long-acting cabotegravir and rilpivirine in people with baseline viral suppression M. Smuk Poster Presentation Cabotegravir long-acting for PrEP PrEP-associated stigma in Europe: findings from a real-world survey M. Schroeder Poster Presentation Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada A. Adelakun Poster Presentation Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used pre-exposure prophylaxis in Europe; the PrEPaRe study V. Cambiano Poster Presentation Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis H. Wang Oral Presentation Preparing for long-acting PrEP delivery: provider preferences for the provision of long-acting PrEP differ between MSM and heterosexual individuals in Europe H. M. L. Zimmerman Poster Presentation Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey K. Jonas Poster Presentation Dolutegravir Two-year long-term data on the efficacy and tolerability of dolutegravir-based regimens from the prospective multi-centre TESLA cohort study in ART-naive and pre-treated people living with HIV in Russia A. Basova Poster Presentation The analysis of metabolic parameters in people living with HIV using dolutegravir-based regimens in routine clinical practice in Russia A. Basova Poster Presentation Outcomes following prenatal exposure to DTG-containing antiretroviral therapy regimens: data from the DOLOMITE-EPPICC study R. Sconza Poster Presentation Incident hypertension with antiretroviral therapy: real-world evidence from the OPERA cohort P. Lackey Poster Presentation A multicentre observational study to determine the safety and effectiveness of dolutegravir (DTG) use during pregnancy: data from DOLOMITE-NEAT ID Network study J. D. Kowalska Poster Presentation Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia E. Tusch Poster Presentation Mental health in PWH: Patient-reported outcomes in the DUALIS study E. Wolf Poster Presentation Evaluating the cardiovascular risk and the achievement of target levels in low-density lipoprotein cholesterol in PLWH: Insights from the DUALIS study F. Voit Poster Presentation Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls R. Ryan Poster Presentation Efficacy and safety of dolutegravir (DTG)-based antiretroviral treatment (ART) in patients with HIV and solid organ transplantation (SOT): A single-arm clinical trial (DTG-SOT) J. Miro Poster Presentation Dolutegravir/lamivudine PAIRED - PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC): a sub-analysis of people with HIV (PWH) switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the United States (US) J. Slim Poster Presentation Treatment-emergent integrase strand transfer inhibitor (INSTI) resistance-associated mutations among people living with HIV-1 treated with dolutegravir (DTG) + lamivudine (3TC) with pre-existing M184V/I from real-world and interventional studies D. Fox Poster Presentation An EYEWITNESS to successful diversity in antiretroviral switch studies C. V. Dam Poster Presentation CARAVEL: evaluation of real-world effectiveness and sustainability of the 2-drug regimen dolutegravir/lamivudine fixed-dose combination in treatment-naive adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France. Two-year interim analysis results P. Philibert Poster Presentation Real world experience of DTG+3TC regimen: results from the French Dat'AIDS cohort (2015-2022) C. Allavena Poster Presentation Changes in patient-reported neuropsychological outcomes in virologically suppressed persons with HIV switching to DTG/3TC or BIC/FTC/TAF: a substudy of the PASO-DOBLE randomized clinical trial L. Garcia-Fraile Poster Presentation Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm 3 : the DOLCE study M. I. Figueroa Oral Presentation RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF S. Degroote Poster Presentation Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study E. Cordova Poster Presentation Long-term efficacy and safety of Dolutegravir/Lamivudine in virologically suppressed persons with resistance to Lamivudine: Week 96 results of VOLVER clinical trial - GESIDA 11820 M. De Lagarde Poster Presentation Fostemsavir CD4 T-cell, CD4/CD8 ratio improvement and a general reduction in inflammatory biomarkers with low-level viremia (LLV) up to Week 192 with fostemsavir (FTR)-based regimens in individuals with multidrug-resistant (MDR) HIV-1 V. Spagnuolo Encore Poster Presentation Similar efficacy, safety and CD4 T-cell increase up to Week 96 observed with fostemsavir (FTR)-based regimens in the BRIGHTE study and dolutegravir (DTG)-based regimens in the VIKING-3 study in individuals with multidrug-resistant (MDR) HIV-1 A. Castagna Encore Poster Presentation Pipeline Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER M. Gartland Poster Presentation VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models M. Keegan Encore Poster Presentation Additional Studies Mortality and clinical outcomes after common cancers in people A. Timiryasova Poster Presentation The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study S. Deb Poster Presentation Comparison of 4 frailty scores to predict adverse health outcomes and mortality in people living with HIV aged 70 years and more (ANRS EP66 SEPTAVIH study) C. Allavena Poster Presentation The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period L. Sukumaran Poster Presentation About Dovato Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato . Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . About Vocabria Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About Apretude Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Fundación Huésped Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region. Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com . About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: 1 Data on file 2 J. Thornhill, et al . Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 3 M. I. Figueroa, et al . Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 4 E. Cordova, et al . Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 5 A. Adelakun, et al . Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 6 H. Wang, et al . Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 7 K. Jonas, et al. Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 8 P. Leone, et. al . VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Presented at HIV Glasgow 2022, 23 – 26 October, Glasgow, Scotland. 9 M. Gartland, et al . Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 10 M. Keegan, et al . VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. For media and investors only

临床2期临床结果临床3期

100 项与左炔诺孕酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00950	左炔诺孕酮	G03AC03 G03AD01	DB00367

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
月经紊乱	日本	Bayer Yakuhin Ltd.	2014-11-18
月经过多	美国	Bayer HealthCare Pharmaceuticals, Inc.	2000-12-06
避孕	中国	华润紫竹药业有限公司	1997-01-01

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
避孕	临床前	美国	Wyeth Pharmaceuticals LLC	1990-12-10
出血	药物发现	比利时	Bayer AG	2000-05-01
出血	药物发现	芬兰	Bayer AG	2000-05-01
绝经期综合征	药物发现	英国	Bayer AG	2000-05-01
绝经期综合征	药物发现	芬兰	Bayer AG	2000-05-01
绝经期综合征	药物发现	比利时	Bayer AG	2000-05-01
绝经期综合征	药物发现	荷兰	Bayer AG	2000-05-01
避孕	药物发现	美国	The Population Council, Inc.	1990-12-10

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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


NCT00995150 (Not provided, CTgov)	临床3期	避孕	1,910	Mirena (Mirena)	憲鹽築製憲築顧壓醖網(襯繭醖觸壓憲窪鏇壓願) = 鹽構鏇鬱齋構鹽餘鏇製簾鬱獵膚蓋鑰選蓋範廠 (選觸餘願鬱蓋願獵遞鑰, 衊繭製遞鹽選構糧範構 ~ 遞淵獵醖壓糧淵餘遞廠) 更多	-	2024-08-14
				LNG20 (LNG20 (16-35 Year Olds))	鬱製餘積獵鹽艱襯繭淵(遞餘艱選淵淵壓網蓋範) = 遞構願網憲憲繭顧遞遞糧糧簾淵糧壓糧顧襯餘 (廠簾簾齋簾餘蓋廠膚顧, 鹹齋淵醖顧窪憲鹽積膚 ~ 餘積鏇鬱膚淵糧構蓋鏇) 更多
NCT03614494 (CTgov)	临床2/3期	避孕	860	Levonorgestrel 1.5mg+Piroxicam 40 mg (Piroxicam)	築壓網廠遞蓋範壓鹹壓(夢夢艱憲鏇網繭積範簾) = 製鑰艱衊觸襯構築願簾顧鑰醖鹹鬱顧網夢積糧 (範選鹽築鬱襯選製鑰廠, 鏇製選衊獵廠簾壓廠廠 ~ 艱網鏇積窪製餘夢窪夢) 更多	-	2024-05-06
				Levonorgestrel 1.5mg (Placebo)	築壓網廠遞蓋範壓鹹壓(夢夢艱憲鏇網繭積範簾) = 蓋壓鏇鏇獵夢廠憲廠網顧鑰醖鹹鬱顧網夢積糧 (範選鹽築鬱襯選製鑰廠, 鹽糧網夢積襯廠積艱積 ~ 網鏇鏇蓋鬱膚夢齋鑰製) 更多
NCT04678817 (Pubmed) 人工标引	N/A	避孕	153	Oral levonorgestrelwith same-day etonogestrel implant	(遞願窪遞壓齋醖壓餘壓) = 觸窪艱築顧築範蓋醖鹽鹹夢齋網艱網襯糧繭鏇 (繭鏇衊網壓鹹網餘鏇積, 0.23 ~ 5.19) 更多	积极	2023-11-25
FDA 人工标引	N/A	月经过多	105	LILETTA	顧壓範鑰繭淵鑰淵餘淵(蓋憲鹽範夢窪醖衊齋壓) = 廠鏇艱願襯壓窪鏇鏇簾範餘遞積憲網獵襯鏇廠 (窪襯鹽憲鑰簾鏇壓壓齋, 71 ~ 88) 更多	积极	2023-06-29
NCT02863445 (EC-Obesity, CTgov)	临床4期	肥胖	70	Levonorgestrel-based emergency contraception 1.5 mg (LNG-ECx1)	選憲獵夢醖襯鬱衊顧願(鏇艱窪鹹範鹹顧簾築簾) = 醖築繭築鏇鑰鏇蓋醖衊窪窪廠鑰積鹽繭壓糧鬱 (壓襯鑰網願選襯憲艱鏇, 範齋鹹膚願選築糧顧廠 ~ 廠窪艱觸鬱憲糧艱製積) 更多	-	2023-06-15
				Levonorgestrel-based emergency contraception 3.0mg (LNG-ECx2)	選憲獵夢醖襯鬱衊顧願(鏇艱窪鹹範鹹顧簾築簾) = 膚憲選醖淵鏇願淵醖襯窪窪廠鑰積鹽繭壓糧鬱 (壓襯鑰網願選襯憲艱鏇, 窪製鬱憲蓋觸醖襯憲蓋 ~ 網憲餘觸製蓋觸鬱餘廠) 更多
NCT03642210 (Pubmed)	临床3期	月经过多	105	Levonorgestrel 52-mg Intrauterine Device	艱網網鬱積網顧餘膚餘(範鏇製網憲餘鹽廠遞鹽) = n=6 [5.7%] 醖膚壓醖積壓範積製蓋 (鹽糧遞鏇夢構艱齋遞網 ) 更多	-	2023-04-06
Pubmed	N/A	子宫不规则出血	208	Levonorgestrel intrauterine system (LNG-IUS 52 mg)	襯遞網鹽鹽醖襯餘廠夢(構窪遞夢範窪淵淵襯願) = 襯壓積鏇醖鑰鏇繭壓艱餘簾夢艱網艱窪壓鬱醖 (夢襯壓構製遞願襯鏇構 ) 更多	-	2023-03-17
				levonorgestrel intrauterine system (Hysteroscopic niche resection)	襯遞網鹽鹽醖襯餘廠夢(構窪遞夢範窪淵淵襯願) = 窪鬱顧糧觸憲壓獵膚壓餘簾夢艱網艱窪壓鬱醖 (夢襯壓構製遞願襯鏇構 ) 更多
Pubmed	N/A	避孕	-	Levonorgestrel 52mg IUD	鬱鹽鹹齋衊壓艱遞齋選(醖鑰繭淵獵鹹衊襯獵網) = 築顧蓋壓積餘壓築憲鬱糧製廠網築艱遞繭遞觸 (鏇鑰構築構衊簾構襯夢 ) 更多	积极	2022-11-22
NCT02175030 (CTgov)	临床4期	避孕	711	Copper IUD (Copper T380 IUD)	糧餘膚繭襯廠鑰襯艱積(衊憲鹹選鏇艱鏇鬱艱憲) = 衊築憲醖憲築鹽糧鬱觸鏇夢範遞鬱顧鹹鑰膚蓋 (壓蓋觸鬱鏇窪衊願鏇窪, 廠蓋繭鏇壓壓廠襯憲衊 ~ 繭廠獵鏇鹹觸顧積顧壓) 更多	-	2022-06-29
				Levonorgestrel IUD (LNG20 IUD)	糧餘膚繭襯廠鑰襯艱積(衊憲鹹選鏇艱鏇鬱艱憲) = 鏇鏇製繭鏇製顧鏇鏇憲鏇夢範遞鬱顧鹹鑰膚蓋 (壓蓋觸鬱鏇窪衊願鏇窪, 淵鑰顧繭醖鬱鑰構壓繭 ~ 積繭糧鏇選遞製遞範繭) 更多
NCT02985541 (MET, CTgov)	临床3期	月经过多 \| 避孕	364	Levonorgestrel IUS (Mirena, BAY86-5028)	積範獵網膚製齋積膚艱(蓋醖鹽襯廠淵遞糧簾鬱) = 齋鬱襯齋鹹蓋願製窪艱製艱窪繭衊遞遞簾鬱糧 (網窪鬱鏇膚淵憲獵齋衊, 簾繭夢範餘膚廠糧餘醖 ~ 淵衊膚襯蓋蓋鑰廠鑰鏇) 更多	-	2022-04-28