An evaluation of efficacy and safety of Statin versus Bempedoic acid versus Bempedoic acid plus Ezetemibe in dyslipidemic North Indian population at tertiary care centre. - BEMPE

开始日期2025-05-01

申办/合作机构

Institute of Medical Sciences, Banaras Hindu University

CTR20251078

/ CompletedN/A

贝派度酸片（180 mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Esperion Therapeutics Inc持证的贝派度酸片（商品名：NEXLETOL®；规格：180mg）为参比制剂，对合肥立方制药股份有限公司生产并提供的受试制剂贝派度酸片（规格：180mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂贝派度酸片（规格：180mg）和参比制剂贝派度酸片（商品名：NEXLETOL®；规格：180mg）的安全性。

开始日期2025-04-08

申办/合作机构

合肥立方制药股份有限公司

NCT06925100

/ Not yet recruiting临床4期

A Multicenter, Prospective, Phase IV, Interventional Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan - The CLEAR Taiwan Study

Cardiovascular disease (CVD) is a chronic non-communicable disease among the most common causes of death worldwide. Substantial reductions in risks of CVD can be achieved through the management of modifiable risk factors, particularly low-density lipoprotein cholesterol (LDL-C). However, only 18.3% of high-risk primary prevention patients and 20.7% of secondary prevention patients achieved the treatment goals based on the 2019 ESC guidelines. Similar trends were reported by the latest European multinational observational SANTORINI study. These real-world evidence data indicate the suboptimal implementation of ESC/EAS 2019 guidelines on LDL-C, particularly the low use of combinational lipid-lowering therapy (LLT), leading to a substantial proportion of patients remaining at high residual risk of ASCVD events.
Bempedoic acid, a first-in-class novel nonstatin lipid-lowering agent, was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 for the treatment of primary hypercholesterolemia. Bempedoic acid inhibits cholesterol biosynthesis through the inhibition of adenosine triphosphate-citrate lyase, an upstream enzyme of 3-hydroxy-3-methylglutaryl-coenzyme A reductase. The unique hepatic activation of bempedoic acid results in limited exposure to skeletal muscle, which prevents musculoskeletal-related adverse events.
Phase II and III RCTs have demonstrated efficacy with adequate safety data of bempedoic acid as mono- or combination therapy with statins and ezetimibe. The CLEAR outcomes trial demonstrated the benefit of bempedoic acid in lowering the risks of major adverse cardiovascular events in statin-intolerant patients.
However, there is limited data on bempedoic acid treatment in East Asian subjects and no data in the Taiwanese population, despite modeling data from large studies indicating the potential for no ethnic differences. To investigate the effectiveness and safety of bempedoic acid in a Taiwanese population, this phase IV study is conducted to examine the treatment outcomes in approximately 180 patients using bempedoic acid in Taiwan.

开始日期2025-04-01

申办/合作机构

台湾第一三共股份有限公司

100 项与贝派地酸相关的临床结果

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100 项与贝派地酸相关的转化医学

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100 项与贝派地酸相关的专利（医药）

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520

项与贝派地酸相关的文献（医药）

2025-12-01·Current Atherosclerosis Reports

Managing Dyslipidemia in Chronic Kidney Disease: Implications for Cardiovascular and Renal Risk

Review

作者: Kalaitzidis, Rigas G ; Vlachakis, Panayotis K ; Theofilis, Panagiotis ; Karakasis, Paschalis

PURPOSE OF REVIEW:

The review aims to address the complex relationship between dyslipidemia and chronic kidney disease (CKD), emphasizing its dual role in driving cardiovascular disease (CVD) risk and contributing to CKD progression. It explores pathophysiological mechanisms, highlights recent biomarker discoveries, and evaluates contemporary and emerging lipid-lowering therapies tailored for CKD patients.

RECENT FINDINGS:

Recent studies have highlighted the inadequacy of traditional lipid markers like LDL-C in reflecting cardiovascular risk in CKD. Novel biomarkers, such as remnant cholesterol and lipoprotein(a), demonstrate stronger associations with adverse outcomes. Emerging lipid-lowering agents, including bempedoic acid, pemafibrate, and PCSK9 inhibitors, show promise for risk reduction, especially in non-dialysis-dependent CKD. However, evidence remains limited for advanced stages of CKD and dialysis patients. Furthermore, alterations in lipid metabolism, such as dysfunctional HDL and triglyceride-rich lipoproteins, are now recognized as significant contributors to CVD and renal damage in CKD populations. Dyslipidemia is a pivotal modifiable risk factor in CKD, exacerbating both cardiovascular risk and disease progression. While statins remain the cornerstone of therapy in early-to-moderate CKD, their efficacy diminishes in advanced stages. The advent of novel therapeutic options and a deeper understanding of dyslipidemia's pathophysiology hold potential for improving outcomes. Future research should prioritize personalized approaches, focusing on the unique metabolic derangements of CKD and advancing treatments for high-risk and dialysis-dependent patients.

2025-12-01·AMERICAN HEART JOURNAL

Utilization and spending on lipid lowering therapies in medicaid from 2018 to 2022

Article

作者: Wadhera, Rishi K ; Beschloss, Alexander ; Oseran, Andrew S

BACKGROUND:

To determine how utilization and spending on lipid lowering medications in Medicaid changed between 2018 and 2022.

METHODS:

Retrospective, cross-sectional study of utilization and spending on 32 lipid lowering drug formulations (18 brand-name, 14 generic) using the Medicaid Spending by Drug Dataset (2018-2022).

RESULTS:

The study included over 115 million prescription fills in the Medicaid program. Between 2018 and 2022, annual prescription fills for lipid lowering medications increased 1.2%, from 22.7 million per year to 22.9 million per year, while annual Medicaid spending on these medications increased 13.2%, from $348.3 million to $394.4 million per year. Annual statin utilization remained stable over the study period (20.4 million fills in 2018 compared to 20.3 million fills in 2022), while spending on statins decreased (from $243.9 million to $228.3 million). Conversely, annual prescription fills and spending for PCSK9 inhibitors (7,617 fills and $8.9 million to 121,737 fills and $65.7 million), icosapent ethyl (32,527 fills and $10.2 million to 180,291 fills and $50.2 million), and bempedoic acid (from 494 fills and $215,499 to 4,619 fills and $2.2 million) all increased between 2018 and 2022.

CONCLUSION:

Between 2018 and 2022, annual prescription fills for lipid lowering therapies in Medicaid remained stable while spending on these medications increased, driven by increased utilization of PCSK9 inhibitors, icosapent ethyl, and bempedoic acid. As Medicaid budgets face escalating financial pressure-and the burden of cardiovascular disease increases among low-income adults in Medicaid-it is critical that policymakers continue to monitor utilization and spending on existing and novel high-cost medical therapies.

2025-07-07·European Heart Journal-Cardiovascular Pharmacotherapy

Expert opinion on the integration of combination therapy into the treatment algorithm for the management of dyslipidaemia: the integration of ezetimibe and bempedoic acid may enhance goal attainment

Review

作者: Zambon, Alberto ; Rietzschel, Ernst ; Aguiar, Carlos ; Parhofer, Klaus G ; Drexel, Heinz ; Gouni-Berthold, Ioanna ; Banach, Maciej ; Pérez de Isla, Leopoldo ; Ray, Kausik K

Abstract:

The clinically important link between LDL cholesterol (LDL - C) lowering and cardiovascular (CV) risk reduction is well-established and reflected in the 2019 European Society of Cardiology/European Atherosclerosis Society guidelines for the management of dyslipidaemia. They recommend a stepwise approach to reaching LDL - C goals, beginning with statin monotherapy at the highest tolerated dose. However, real-world data show a large gap between guideline LDL - C goal recommendations and their achievement in clinical practice. The treatment paradigm should shift from the concept of high-intensity statins to that of high-intensity, lipid-lowering therapy (LLT), preferably as upfront combination LLT, to overcome the residual CV risk associated with inadequate lipid management.A multidisciplinary expert panel convened to propose treatment algorithms to support this treatment approach in patients at high and very high CV risk. The experts completed a questionnaire on the benefits of combination therapy and the role that novel LLTs, including bempedoic acid, might play in future guidelines. The integration of new LLTs into the suggested treatment algorithms for patients at high CV risk, very high CV risk, and those with complete or partial statin intolerance was discussed. Each algorithm considers baseline CV risk and LDL - C levels when recommending the initial treatment strategy. This expert consensus endorses the use of statin combination therapy as first-line therapy in patients at high and very high CV risk, and, in some circumstances, in patients with statin intolerance when appropriate. Given recent, compelling evidence, including real-world data, combination therapy as first-line treatment should be considered to help patients achieve their LDL - C goals.

148

项与贝派地酸相关的新闻（医药）

2025-07-09

·同写意

默沙东“回马枪”：时隔两年，再现100亿美元并购

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！7月9日，据Financial Times报道，默沙东即将达成一项约100亿美元的并购协议，被相中的是一家成立于2005年的生物科技公司Verona，专注开发肺病疗法。Verona旗下拥有一款商业化产品Ohtuvayre，已经获得FDA批准用于治疗慢性阻塞性肺病（COPD）。分析师预测，到2035年左右，该药物的年销售额峰值可能达到近40亿美元。目前，Ohtuvayre也正在探索用于治疗其他肺部疾病。如果买卖最终如期达成，这会是默沙东近两年来进行的最大规模收购。TONACEA01“药王”替补2023年，默沙东斥资108亿美元收购Prometheus Biosciences，值得注意的是，后者也手握上市产品，拥有不错的营收。默沙东希望，借助这些并购扩张，能够填补其现有重磅药物专利到期后留下的空缺。抗癌药物Keytruda仍是全球“药王”：2024年财年，销售额同比增长18%，达到294.82亿美元。自2014年上市以来，Keytruda凭借其创新的PD-1机制，迅速成为肿瘤免疫治疗领域的明星药物。2023年，Keytruda首次以250.11亿美元的销售额，超过Humira登顶最畅销药物排行榜，标志着肿瘤免疫疗法的里程碑。然而，Keytruda在美国的专利将于2028年到期，届时便开始面临生物类似药的竞争。安进、三星Bioepis都已摩拳擦掌，准备推出各自的Keytruda生物类似药。到2028年或2029年，美国市场可能会出现大量的生物类似药。2028年也是Keytruda面临Medicare价格谈判的关键节点——上市的第14年。IRA规定，美国上市满9年（小分子）或13年（生物制剂）的药物，会被纳入协商降价框架。默沙东的股价在过去一年中下跌了35%，截至7月8日收盘，其市值为2030亿美元。Ohtuvayre等新产品，将是默沙东“后Keytruda时代”的希望之一。三位知情人士透露，作为交易的一部分，默沙东将以每股107美元的价格收购Verona，较该公司7月8日的收盘价溢价23%。此次收购，对这家专注于呼吸系统疾病的生物科技公司的估值约为100亿美元。据悉，默沙东和Verona之间的谈判已进入后期阶段。倘若不出意外，可能近期就会对外宣布。Verona的Ohtuvayre是在2024年登陆美国市场，开局良好，截至2025年第一季度末已开出2.5万张处方，超出分析师的预期。知情人士补充说，默沙东的收购将加速该药物在美国以外国家的商业化进程。目前，默沙东正准备推出一系列新产品，并计划在未来五年内推出比其历史上同期更多的药物。Ohtuvayre是首个获批用于COPD维持治疗的全新吸入式药物。数据显示，COPD是导致死亡的主要原因，会破坏肺组织和功能。与现有的COPD药物不同，Ohtuvayre并非基于类固醇的药物，而是通过抑制两种不同的酶来发挥作用，从而扩张呼吸道并减轻炎症。除了Ohtuvayre，总部位于伦敦的Verona，还布局研究对其他多种肺部疾病患者的相同治疗方法，包括支气管扩张、哮喘和囊性纤维化，以及与另一种COPD药物联合使用，这可能会在未来几年扩大该药物的治疗范围。TONACEA02加大“火力”显然，收购Verona将有助于默沙东在呼吸医学领域站稳脚跟。2024年，FDA批准了Winrevair的上市申请。Winrevair是一种用于治疗影响肺部和心脏的潜在致命疾病的药物，2021年默沙东以115亿美元收购Acceleron Pharma，获得了这款产品。自2021年4月默沙东首席执行官Rob Davis上任以来，以交易数量和支出金额衡量，这家MNC已成为收购和授权交易最活跃的制药巨头之一。但近几个月来，投资者强烈要求进行更多交易，以抵消Keytruda专利悬崖带来的销售下滑。与此同时，由于特朗普政府可能进行药品定价改革、关税威胁，以及美国高级卫生官员、众所周知的疫苗怀疑论者小罗伯特·F·肯尼迪领导下的监管和公共卫生机构的变化，今年美国生物制药领域一直处于不稳定状态。默沙东面临的挑战，因其畅销的HPV疫苗Gardasil在中国的销售放缓而加剧。特朗普政府的关税政策，促使默沙东在5月下调了其2025年的销售预期。Davis此前曾表示，默沙东正在寻找价值10亿至150亿美元的交易，如果合适的目标出现，交易金额甚至会更高。今年早些时候，默沙东与恒瑞医药达成了一项高达22亿美元的许可协议，获得了其心脏病药物的全球权利。另一则来自心血管领域的消息，是6月默沙东宣布其开发的Enlicitide在两项III期临床中取得成功，令这家曾经引领他汀类药物风潮的MNC，再次来到口服PCSK9抑制剂的时代跟前。默沙东一项研究将Enlicitide与安慰剂对比，受试者为已服用他汀类药物且患有导致高胆固醇的遗传疾病或动脉粥样硬化风险的人群。试验显示，Enlicitide治疗组的LDL-C水平出现显著下降。另一项研究，则在服用他汀类药物且血脂水平异常偏高的患者中，评估了Enlicitide与其他口服疗法（Ezetimibe、Bempedoic acid）的疗效差异。相关具体临床数据尚未被透露，默沙东承诺，Enlicitide这两项后期研究都达到统计学意义上的LDL-C情况改善。志在变革PCSK9药物市场的Enlicitide，也被纳入到默沙东的未来叙事里。不过，Barron's的一篇文章指出，虽然Enlicitide研发进展较快，但它有个重大缺陷：患者服药前八小时内不能进食。阿斯利康表示，其口服PCSK9药物AZD0780则不必如此。Citi Research分析师认为，默沙东想要真正站稳脚跟，Enlicitide至少得将LDL-C水平降低50%至60%。参考资料：Merck nears $10bn deal for respiratory drugmaker Verona

并购生物类似药专利到期免疫疗法

2025-07-08

·esperion.com

Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040

ANN ARBOR, Mich., July 08, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur. The pending patent litigation against the remaining defendants (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040. About Esperion Therapeutics Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding pending patent litigation and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. Esperion Contact Information: Investors: Alina Venezia investorrelations@esperion.com (734) 887-3903 Media: Tiffany Aldrich corporateteam@esperion.com (616) 443-8438

专利侵权专利到期

2025-06-18

·摩熵医药

68款新药IND获批！87款品种过评，石家庄四药领跑…

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。PART 01周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年6月9日至2025年6月15日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。PART 02国内68款新药IND获批根据摩熵医药数据库统计，2025年6月9日至6月15日期间共有110个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号67个，进口药品受理号43个。本周共计68款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药34款，生物药31款，中药3款。本周获批临床创新药/改良型新药部分信息速览（不含补充申请）注：完整数据可识别“文末”二维码下载查看PART 03本周全球TOP10创新药研发进展在全球创新药研发领域，6月9日，丽珠医药宣布，公司1类创新药YJH-012的临床试验申请（IND）已于近日获中国国家药品监督管理局（NMPA）正式受理。该药物基于小干扰RNA（siRNA）技术开发，有望为患者提供疗效更好、安全性更高的长效痛风治疗方案。根据丽珠医药新闻稿介绍，YJH-012针对痛风伴高尿酸血症，区别于传统药物抑制酶活性以阻断尿酸合成，实现了从基因层面源头长效抑制尿酸生成的机制突破，有望为临床提供更长效、更安全、更彻底的解决方案。该药物的核心机制是利用小干扰RNA（siRNA）技术，将经过化学修饰的双链结构分子，通过特定的肝靶向递送系统GalNAc，精准递送至尿酸合成的主要场所——肝脏。在肝细胞内，siRNA分子与RNA诱导沉默复合体（RISC）结合，RISC中的解旋酶分离siRNA双链，释放其引导链，该引导链精确识别并结合靶蛋白对应的信使RNA（mRNA），并引导RISC中的剪切酶将其切割降解。被破坏的mRNA无法再作为模板合成目标蛋白，从而在源头上显著降低了关键致病蛋白的生成量，阻断了尿酸生成通路。6月13日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，礼来的脂蛋白(a)（Lp(a)）小分子抑制剂 LY3473329（muvalaplin）拟纳入突破性疗法，用于治疗伴有Lp(a)水平升高且确诊心血管疾病或发生首次心血管事件风险升高的成人患者。Muvalaplin是一种first-in-class的口服Lp(a)小分子抑制剂，目前处于II期临床期研究阶段。该药通过阻断载脂蛋白(a)[apo(a)] 和载脂蛋白B (apoB)之间的初始相互作用来抑制Lp(a)的形成。升高的Lp(a)水平会使心脏病发作的风险增加一倍甚至三倍，并与其他心血管问题有关。2024年11月，礼来宣布muvalaplin一项II期取得积极结果，该药显著降低了成人升高的Lp(a)水平，达到了其主要终点。Muvalaplin作为靶向 Lp(a) 的口服降脂药，与传统降脂药相比，口服给药方式打破了注射剂型的不便，大大提高了患者的用药依从性，让降脂治疗更加便捷高效。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报PART 04本周全球TOP10临床试验结果本周全球TOP10临床结果中，6月9日，默沙东（MSD）公司宣布，其在研口服PCSK9抑制剂 enlicitide decanoate（MK-0616）在三项3期临床试验中的前两项取得积极结果，显示该疗法能有效用于治疗正在接受降脂治疗（包括至少使用他汀类药物）的高脂血症成人患者。根据新闻稿，enlicitide decanoate 有望成为获美国FDA批准的首款口服PCSK9抑制剂。这次所公布的CORALreef HeFH与CORALreef AddOn皆为随机、双盲、安慰剂对照的多中心3期研究。CORALreef HeFH旨在评估enlicitide decanoate与安慰剂相比在患有异合子家族性高胆固醇血症（HeFH）成人中的安全性和疗效。CORALreef AddOn则旨在评估enlicitide decanoate与依折麦布、bempedoic acid以及依折麦布与bempedoic acid联合疗法相比，在接受他汀治疗的高胆固醇血症患者中的疗效和安全性。分析显示，CORALreef HeFH和CORALreef AddOn试验均成功达到主要终点和所有关键次要终点。数据显示，与安慰剂（CORALreef HeFH）或其他口服非他汀类药物（CORALreef AddOn）相比，enlicitide decanoate 在降低患者的LDL-C水平方面具有统计学显著性和临床意义的改善。此外，在两项研究中使用该疗法患者的不良事件和严重不良事件（SAE）的发生率，与对照组相较在临床上无显著差异。本周全球 TOP10 积极/失败临床结果截图来源：摩熵咨询周报PART 0587款品种过评，石家庄四药领跑根据摩熵医药数据库统计，2025年6月9日至6月15日期间共有137项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号114项（包括化药3类，4类），新注册分类临床申请受理号6项（包括化药3类，4类），一致性评价申请17项。本周1个品种通过一致性评价（按受理号计3项），86个品种视同通过一致性评价（按受理号计136项）。本周有4项生物类似物注册申报动态，分别是山东新时代的司美格鲁肽注射液，山东博安的纳武利尤单抗注射液（按受理号计2项）和步长制药的阿达木单抗注射液。截图来源：摩熵咨询周报本周过评/视同过评品种主要为心血管系统药物；过评/视同过评产品剂型主要为注射剂；本周注射用苯唑西林钠过评/视同过评受理号数量最多达8个，同时注射用苯唑西林钠也是本周过评/视同过评企业最多的品种达4家；本周石家庄四药有限公司和浙江高跖医药科技股份有限公司过评/视同过评品种数最多达3种，本周过评/视同过评企业共包括石家庄四药有限公司、陕西天宇制药有限公司和青岛黄海制药有限责任公司等94家企业。截图来源：摩熵咨询周报本周有氟[18F]贝他吡注射液、氨磺必利注射液、盐酸曲唑酮片、左羟丙哌嗪口服溶液、培哚普利氨氯地平片(Ⅰ)、肾上腺素注射液、复方匹可硫酸钠口服溶液、去氧胆酸注射液8个品种首次过评/视同过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有盐酸溴己新口服溶液、铝碳酸镁混悬液、吸入用盐酸氨溴索溶液3个品种过评/视同过评达7家企业。本周过评/视同过评达7家企业品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

临床申请siRNA信使RNA

100 项与贝派地酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10691	贝派地酸	C10AX15	DB11936

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
心血管疾病	美国	Esperion Therapeutics, Inc.	2024-03-22
心肌梗塞	美国	Esperion Therapeutics, Inc.	2024-03-22
原发性高脂血症	美国	Esperion Therapeutics, Inc.	2024-03-22
血脂障碍	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
血脂障碍	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	欧盟	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	冰岛	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	列支敦士登	Daiichi Sankyo Europe GmbH	2020-04-01
原发性高胆固醇血症	挪威	Daiichi Sankyo Europe GmbH	2020-04-01
动脉粥样硬化	美国	Esperion Therapeutics, Inc.	2020-02-21
杂合子家族性高胆固醇血症	美国	Esperion Therapeutics, Inc.	2020-02-21

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
高胆固醇血症	申请上市	日本	Otsuka Pharmaceutical Co., Ltd.	2024-11-26
高低密度脂蛋白胆固醇血症	临床3期	日本	Otsuka Pharmaceutical Co., Ltd.	2023-02-13
高脂血症	临床3期	美国	Esperion Therapeutics, Inc.	2017-10-23
脑血管疾病	临床3期	美国	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	阿根廷	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	澳大利亚	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	奥地利	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	比利时	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	巴西	Esperion Therapeutics, Inc.	2016-12-22
脑血管疾病	临床3期	保加利亚	Esperion Therapeutics, Inc.	2016-12-22

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05683340 (CTgov)	临床3期	高低密度脂蛋白胆固醇血症	96	Placebo	築構艱艱鬱製淵艱淵齋(顧選餘築鑰網壓鑰獵醖) = 鬱願廠製構觸簾壓蓋築遞夢網構築齋憲夢窪衊 (夢醖鏇廠鹽淵憲蓋窪選, 1.901) 更多	-	2025-03-13
NCT02993406 (CLEAR Outcomes, Pubmed \| J Am Heart Assoc)	临床3期	肥胖	6,177	Bempedoic Acid 180 mg	構糧壓遞遞醖糧鑰範築(繭網鹹願觸齋鹽齋鹹製) = 膚製選壓構顧壓膚膚願鹹網構鬱壓艱艱糧簾網 (鬱鹹壓鏇壓壓選遞醖選, 0.76 [0.63 ~ 0.92]) 更多	积极	2025-02-18
				Placebo	-
ESC2024	N/A	心血管疾病	-	Bempedoic acid 180 mg daily	觸艱願製鬱製鏇憲窪窪(獵選鬱鑰齋鑰獵鑰選蓋): OR = 0.84 (95% CI, 0.76 ~ 0.96)	积极	2024-08-30
				Placebo
ENDO2024	N/A	2型糖尿病 \| 高胆固醇血症	7,475	Bempedoic acid	鏇蓋構鏇壓壓膚築淵遞(鬱網鏇鹹繭鏇築艱鏇顧) = 製糧繭範憲蓋觸選遞繭鬱醖構鹽夢蓋廠觸醖顧 (鑰醖壓醖衊鹽鏇鏇繭夢, -37.56 ~ -22.82) 更多	积极	2024-06-01
NCT05683340 (Company_Website) 人工标引	临床3期	高胆固醇血症	96	Bempedoic acid 180 mg	窪衊獵繭積遞顧繭鏇餘(艱衊遞築憲繭廠淵觸廠) = 鬱繭願窪鹹範鹹範製淵窪鏇積艱繭網繭鹹艱顧 (選艱鑰願顧夢窪構網積 ) 达到	积极	2024-05-20
				Placebo	窪衊獵繭積遞顧繭鏇餘(艱衊遞築憲繭廠淵觸廠) = 顧顧積築壓積積遞築壓窪鏇積艱繭網繭鹹艱顧 (選艱鑰願顧夢窪構網積 ) 达到
NCT04784442 (CTgov)	临床2期	高胆固醇血症	188	Placebo	糧鑰築醖鑰艱膚獵鬱願(窪選餘糧齋顧積遞積鹹) = 選鹽製夢齋遞簾網築膚夢鏇獵壓膚壓顧鑰窪積 (鑰鬱築構糧獵艱夢鏇鏇, 2.117) 更多	-	2024-03-04
NCT02993406 (CLEAR Outcomes, CTgov)	临床3期	心血管疾病 \| 冠心病 \| 脑血管疾病 ... 更多	13,970	Bempedoic acid 180 mg tablet (Bempedoic Acid 180 mg)	廠餘艱遞廠鏇製壓構齋 = 餘獵簾醖壓構憲構鏇繭鹹憲鏇顧網憲醖獵醖醖 (築壓鑰糧鬱積積憲膚膚, 壓夢衊艱鬱簾獵製鏇衊 ~ 範齋遞鑰鹹衊醖獵網憲) 更多	-	2024-01-03
				Matching placebo tablet (Placebo Comparator)	廠餘艱遞廠鏇製壓構齋 = 衊鬱膚顧築憲鹽顧選憲鹹憲鏇顧網憲醖獵醖醖 (築壓鑰糧鬱積積憲膚膚, 鹹觸鏇窪簾積醖膚壓餘 ~ 糧廠糧憲壓衊憲衊願顧) 更多
NCT02993406 (CLEAR Outcomes, ENDO2023)	临床3期	心血管疾病 \| 冠心病 \| 脑血管疾病 ... 更多	-	Bempedoic Acid	範壓遞範餘鬱糧夢築鏇(衊齋繭壓夢壓衊齋築積) = 艱鹹製鏇壓鑰醖憲遞鹽廠築顧鑰夢夢齋廠鬱遞 (遞憲範夢憲夢繭鹹繭艱 )	积极	2023-10-05
MILOS (ESC2023)	N/A	-	992	Bempedoic acid	窪簾艱壓積窪鏇艱醖鹹(憲遞憲繭憲遞壓憲鑰積) = 糧餘蓋醖齋齋網鑰艱獵餘衊構齋鹹壓製築築窪 (廠構鏇膚獵選衊鬱積鏇, (84.1)) 更多	-	2023-08-26
				Bempedoic acid + ezetimibe	窪簾艱壓積窪鏇艱醖鹹(憲遞憲繭憲遞壓憲鑰積) = 範鏇繭鹽鹹廠襯鏇膚範餘衊構齋鹹壓製築築窪 (廠構鏇膚獵選衊鬱積鏇, (123.6)) 更多
NCT02993406 (Pubmed \| JAMA)	临床3期	-	4,206	Bempedoic Acid	夢願顧獵鑰範遞膚糧鑰(鏇醖繭襯鏇廠衊獵鬱衊): HR = 0.61 (95% CI, 0.39 ~ 0.98) 更多	积极	2023-06-24
				Placebo