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更新于：2025-07-19

Simvastatin

辛伐他汀

更新于：2025-07-19

概要

基本信息

简介辛伐他汀是一种小分子实体，作为 HMG-CoA 还原酶抑制剂起作用，它负责肝组织中胆固醇的合成。它被归类为 HMG-CoA 还原酶抑制剂或他汀类药物，可治疗由胆固醇水平升高引起的各种疾病。辛伐他汀的有效适应症包括杂合子家族性高胆固醇血症、V 型高脂蛋白血症、中风、高脂血症和 II 型高脂蛋白血症。 Merck Sharp & Dohme Corp. 最初合成了辛伐他汀，并于 1988 年首次获准用于临床。尽管它被普遍使用，但辛伐他汀可能会引起一系列副作用，例如肌痛和肝毒性，患者应寻求咨询在开始摄入之前从他们的医生那里获得。

药物类型

小分子化药

别名

Simvastatin (JP17/USP/INN)、Simvastatin for Suspension、Simvastatin Unlubricated Granulation

+ [44]

靶点

HMGCR

作用方式

抑制剂

作用机制

HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [1]

在研适应症

V型高脂蛋白血症冠状动脉疾病高脂血症+ [5]

非在研适应症

急性冠状动脉综合征阿尔茨海默症心房颤动+ [12]

原研机构

Merck Sharp & Dohme Corp.

在研机构

Organon & Co.

Salerno Pharma

Organon Pharma Pty Ltd.

+ [1]

非在研机构

Merck Sharp & Dohme Corp.Synthon Pharmaceuticals, Inc.Merck Sharp & Dohme LLC

权益机构-

最高研发阶段批准上市

首次获批日期

澳大利亚 (1991-09-12),

冠心病杂合子家族性高胆固醇血症高胆固醇血症+ [1]

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C25H38O5

InChIKeyRYMZZMVNJRMUDD-HGQWONQESA-N

CAS号79902-63-9

关联

651

项与辛伐他汀相关的临床试验

NCT06431919

/ RecruitingN/A

Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial

Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
Rationale:
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.
Novelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.
Objectives:
The primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.
Methods:
This is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.
Expected Outcome:
The investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).

开始日期2025-06-10

申办/合作机构

Post Graduate Institute of Medical Education & Research

[+1]

NCT07003815

/ Not yet recruiting临床2期IIT

A Single-Arm, Exploratory Clinical Study of Envafolimab Combined With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Locally Advanced or Metastatic BTC Patients

Brief Summary
The goal of this clinical trial is to test whether the combination of Envafolimab (an immunotherapy drug), chemotherapy (gemcitabine + cisplatin), and simvastatin can help treat advanced biliary tract cancer (BTC) that cannot be removed by surgery or has spread. The study will also evaluate the safety of this treatment combination.
Key Questions Does the combination treatment help shrink tumors or slow cancer growth better than standard options? What side effects do participants experience with this treatment?
What Will Participants Do? Receive Envafolimab (IV infusion) + gemcitabine/cisplatin (chemotherapy) + simvastatin (oral pill) every 3 weeks for up to 8 cycles (
6 months).
After 8 cycles, continue with Envafolimab + simvastatin alone every 4 weeks until cancer worsens or side effects become too severe.
Undergo regular scans, blood tests, and clinic visits to monitor tumor response and safety.

开始日期2025-06-01

申办/合作机构-

NCT06948747

/ Recruiting临床1期

An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants

This study will assess the effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the effect of Erythromycin on AZD5004 in healthy adult male and female participants.

开始日期2025-05-06

申办/合作机构

AstraZeneca PLC

100 项与辛伐他汀相关的临床结果

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100 项与辛伐他汀相关的转化医学

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100 项与辛伐他汀相关的专利（医药）

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19,344

项与辛伐他汀相关的文献（医药）

2025-12-31·JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Simvastatin-loaded liposomal nanoparticles as treatment for adenomyosis in a patient-derived xenograft mouse model: a pilot study

Article

作者: Saada, Jamal ; Kilic, Gokhan S. ; Ozpolat, Bulent ; Yang, Jinping ; Kirschen, Gregory W. ; Borahay, Mostafa A. ; Vincent, Kathleen L. ; Motamedi, Massoud ; Michel, Rachel

BACKGROUND:

Adenomyosis is a common gynaecological condition where ectopic endometrial glands and stroma grow within the myometrium. This condition has a high clinical burden impacting those afflicted with debilitating symptoms including heavy painful periods. Simvastatin is an oral hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, typically used to treat hyperlipidaemia. Simvastatin has recently shown promise for treating gynaecological conditions such as endometriosis and uterine fibroids with nanoliposomal formulations demonstrating improved efficacy. In this pilot study, we tested simvastatin-loaded liposomal nanoparticles on xenografted adenomyosis tissues in a patient-derived mouse model.

METHODS:

We surgically inserted oestrogen/progesterone pellets into mice, followed by adenomyosis tissue xenografts 15 days later. Mice were then randomised into three groups: control, simvastatin, and simvastatin-loaded liposomal nanoparticles (simvastatin-NP). We quantified the changes in adenomyosis xenograft size weekly using a calliper as well as ultrasound imaging 28 days after treatment, prior to sacrifice. We also measured the proliferation of biomarker Ki67 in the xenografted tissues using immunohistochemistry after animal sacrifice.

RESULTS:

Treatment with simvastatin-NP significantly reduced volume and weight of adenomyosis xenografts while attenuating Ki67 expression when compared to the control and simvastatin groups. Conclusions: This pilot study demonstrates promising improved efficacy of simvastatin delivered via liposomal nanoparticles. However, larger studies are needed to fully explore the potential of simvastatin-NP in adenomyosis.

2025-09-01·VASCULAR PHARMACOLOGY

Effects of simvastatin treatment on leptomeningeal collateral vessels: resistance, number and diameter

Article

作者: Beard, Daniel J ; Clark, David ; Coupland, Kirsten G ; Scott, Thomas R ; Martin, Kristy ; Williams, Fern ; Amell, Merce Fuentes ; Spratt, Neil J

Good leptomeningeal collateral vessels (LMC) are associated with smaller lesion volume and better patient outcomes from ischaemic stroke, but their architecture varies greatly between individuals. Statins can stimulate angiogenesis and show promise for stimulating cerebral collaterogenesis. Statins could thus improve LMC grade and ensure all patients receive positive outcomes from treatment. This potentially explains why statin treatment is effective given prior to stroke in pre-clinical models, but not prescribed afterwards in clinical trials. LMC-rich C57Bl/6 and LMC-poor BALB/c 12-week-old male mice were randomised to receive daily oral simvastatin (10 mg/kg) or vehicle for 4 weeks. The cerebrovasculature was silicone-perfused, allowing LMC numbers and dimensions to be analysed. Values for tortuosity, vascularity and LMC resistance were calculated. In BALB/c, estimated resistance was lower with simvastatin treatment (vehicle: 0.104 ± 0.09, simvastatin: 0.023 ± 0.02; p = 0.04) and LMC numbers were greater (vehicle: 1.6 ± 1.6, simvastatin: 4.0 ± 3.2; p = 0.04). In C57Bl/6, there was no difference to resistance, but LMCs were smaller in diameter (vehicle: 16.3 ± 1.8 μm, simvastatin: 14.0 ± 1.4 μm, p = 0.008). Statin-treated C57Bl/6 also had more arterial branchpoints (left hemisphere, vehicle: 363.8 ± 55 per cm2, simvastatin: 417.3 ± 58 per cm2, p = 0.007; right, vehicle: 315.1 ± 40 per cm2, simvastatin: 397.5 ± 43 per cm2, p < 0.0001). We have observed signs of collaterogenesis and angiogenesis, providing evidence that statins stimulate growth of LMCs. Greatest benefit was seen in LMC-poor BALB/c, suggesting that patients with poor LMC circulation stand to gain most from LMC-enhancing therapies. Patients receiving statins prior to stroke have likely developed better LMCs, leading to better stroke outcomes. These findings should stimulate investigation of further safe, widely-available LMC-enhancing therapies.

2025-09-01·ENVIRONMENTAL POLLUTION

Validation of a large volume-solid phase extraction methodology for biotoxicity assessment of pharmaceuticals in aquatic organisms

Article

作者: Gómez-Canela, Cristian ; Moragrega-Knol, Emma ; Barata, Carlos ; Romero-Alfano, Irene

The growing scarcity of freshwater has intensified the need for alternative water sources, which often require advanced treatments to eliminate contaminants. Among emerging pollutants, pharmaceuticals have become a significant concern due to their persistence and potential impact, making their detection essential. However, analysing these contaminants is challenging due to the extremely low concentrations at which they are present. For chemical analysis, minimal or no sample enrichment is often necessary, while bioanalysis typically requires larger sample volumes and an enrichment factor to conduct comprehensive bioassays across various endpoints. Consequently, sample preconcentration techniques for large water volumes are necessary to improve the sensitivity of subsequent toxicological experiments. In this study, a novel large volume solid-phase extraction (LV-SPE) procedure was validated and evaluated for monitoring multiple pharmaceutical compounds in water samples, while maintaining the traditional solid-phase extraction (SPE) methodology using cartridges. This method proved effective extraction and preconcentration of significant amounts of water, with recoveries between 19 % and 109 % in spiked wastewaters (except for fluvoxamine, remdesivir, tamoxifen and tetracycline, with recoveries <10 %). Furthermore, the optimization of this approach covers an expansive chemical space, enabling the capture of a diverse range of pharmaceutical compounds and enhancing the validity of toxicological studies. Bioassays conducted with Daphnia magna juveniles and Danio rerio embryos validated the method's applicability regarding optimized exposure conditions, the absence of adverse effects from SPE blanks or solvent controls and sensitivity in detecting effects across field samples. Overall, the LV-SPE approach enhances sensitivity and reliability for evaluating pharmaceutical mixtures' risks under realistic conditions.

232

项与辛伐他汀相关的新闻（医药）

2025-07-07

·癌度

烧脑文！对于可逆和不可逆靶向药耐药问题，对于正在“保命”的癌细胞我们有什么办法？

临床试验入组病友交流群（点击）对于重病之王癌症我们很无奈，这个疾病的问题才在一个药物用上去之后会耐药，而我们对癌细胞耐药的问题研究的不算是那么清楚。最近发布在国际学术期刊的一个文献报道了耐药问题。这是美国哈佛大学研究团队提出的整合不可逆基因耐药、可逆细胞耐药的双机制数学模型。使用600万虚拟患者大样本模型做的研究，整体这篇文章相当烧脑，癌度从里面摘取关键的内容给大家做一些解释，希望下面的信息对大家有所帮助。（如您希望挑战自己的烧脑能力，欢迎联系癌度所需文献全文）本文参考文献刊例示意图1、为什么会出现耐药？癌细胞在“保命”对于治疗的耐药我们目前的金标准是影像学CT或核磁检查发现病灶增大超过了20%，或者是出现了新的转移灶，但是这往往属于“黄花菜都凉透”的耐药结论，CT能看到最小的病灶在1厘米左右，这个时候的病灶含有10亿个癌细胞。癌细胞早就进化了多少代了。要是想避免耐药，我们需要了解什么是耐药，耐药的原因和类别。当患者使用靶向药或免疫药时，癌细胞不会“坐以待毙”。它们会想尽办法活下来，就像人遇到危险会找掩体或逃跑一样。主要靠两种方式可逆耐药和不可逆耐药。1、“换装备”型耐药（不可逆耐药），发生的原因是癌细胞基因突变了（比如EGFR T790M突变、ALK G1202R突变），相当于给自己换了套防弹衣，药物再也打不穿。这种变化是永久性的。通常用药>6个月后才出现，肿瘤全面进展（原病灶+转移灶都长大）。常见于肺癌（EGFR/ALK靶向药）、乳腺癌（HER2靶向药）等。2、“装死”型耐药（可逆耐药），癌细胞没变基因，而是临时改变行为——比如把药物“泵出”细胞外，或启动备用信号通路躲过攻击。相当于敌人暂时趴下装死，等你一走又站起来。表现为用药初期有效，但肿瘤标志物（如CEA）缓慢升高，或出现局部新转移（如脑转、骨转），而原病灶仍控制良好。常见于抗血管生成药（如阿帕替尼、安罗替尼）、部分免疫治疗（如PD-1抑制剂）。但是停药之后可以逆转。目前我们的精准医学是做基因检测，判断出癌细胞主要的群体携带的基因突变是什么，比如EGFR或ALK，并根据驱动基因突变使用靶向药。但是忽略了两种耐药的时空交互作用，注意不是说不知道上面的耐药问题，而是忽略了可逆耐药和不可逆耐药的相互协同带来的后果。2、耐药后怎么办？分情况应对对于耐药出现之后患者要怎么办？这里还是要判断出来耐药的情况，然后才能选择对应的方案。第一种情况，疑似缓慢耐药，表现为肿瘤标志物CEA升高，但是CT或核磁检查病灶稳定。这个时候不需要着急换药，每个月检查一次肿瘤标志物CEA，2个月检查一次CT，并和医生讨论是否使用局部治疗（如骨转用唑来膦酸，脑转用放疗），有患者CEA升高后继续用原药1个月，再化疗4次，CEA回落，重新用回原药仍有效。第二种情况是确定了不可逆耐药，患者表现为全面进展。这个时候就需要做基因检测，用血液或新活检组织做检测，找出新突变（如肺癌EGFR药耐药后常见T790M、C797S突变）；若有对应下一代药（如奥希替尼治T790M），直接换药，或者是通过参加临床试验。如果找不到耐药基因突变怎么办？答案是考虑其他机制的靶向药联合化疗联合（如“贝伐珠单抗+培美曲塞”）；或参加跨癌种新药试验，如抗体偶联药ADC、免疫检查点抑制剂靶向药偶联药IDCs。第三种情况是确定了可逆耐药，属于局部进展，核心策略是 “停药休息”+“联合增敏”，所谓的停药休息是让医生安排1-2个月“药物假期”，让癌细胞恢复对靶向药的敏感性；而联合增敏是指联合用药，比如胃癌阿帕替尼耐药，则可以联用辛伐他汀（降胆固醇药，破坏癌细胞防盾），三阴性乳腺癌免疫耐药可以联用色甘酸钠（抗过敏药，激活免疫细胞），有效率从10%提升至50%。3、未来的新策略是什么？这一篇参考文献讲述的内容非常学术和理论，当然如果说换成老百姓能看得懂的文字还是需要一定时间。这个研究通过600万虚拟患者来设计数学模型，预判癌细胞下一步的行为，提前换药堵路，比传统的治疗延长9%的生存期，也就是相当于多活4到10个月。目前有临床试验正在研究乳腺癌的三药轮换，肺癌EGFR靶向药的序贯。相信以后会有相应的结论出来。此外还有一些办法，比如韩国人发现肺癌EGFR耐药后存在3类亚克隆，第一类是癌细胞伪装成为间质细胞，可以用Wnt抑制剂（如XAV-939）治疗，还有癌细胞是具有高侵袭性，则使用激光激酶抑制剂剂（如Barasertib）治疗，联合用药的有效率提升了3倍。这么多药物你记不住，或者分析不清楚，作为癌度撰稿十多年的我也不清楚，但是人工智能会给我们分析清楚。这也是为何我们对未来可以乐观的原因。最黑暗的时刻是发现耐药那一刻，但也是治疗真正走向精准的开始。每一次耐药都在暴露癌细胞的弱点，而现代医学正学会如何抓住这些弱点反击。—— 希望这句话能给你力量。喜欢本文，欢迎扫描下面的二维码联系我，加入癌度病友群交流！参考文献：Wei He，et al., Personalized cancer treatment strategies incorporating irreversible and reversible drug resistance mechanisms, npj systems biology and applications, 2025. 往期推荐 KRAS突变全覆盖？daraxonrasib（RMC-6236）让RAS药物不再挑三拣四！溶瘤病毒在第一大癌种获得突破，BRACELET-01研究证实乳腺癌从溶瘤病毒治疗获益！脑转？第三代靶向药 + 新型抗体偶联药，打破EGFR突变肺癌脑转移困局！早期和晚期肠癌接受CIK细胞疗法联合化疗或手术均能获益，而CEA水平是一个能否有效的指示器！

放射疗法疫苗免疫疗法

2025-07-03

·法伯科技Pharbers

百亿他汀类药物，多渠道市场发展格局

前言根据《中国居民营养与慢性病状况报告（2020）》显示，我国18岁及以上居民高血脂总体患病率高达35.6%，庞大的患者规模正为国家带来严重的疾病负担。从市场份额来看，目前他汀类药物仍然是降脂药领域的主力。根据法伯全渠道数据显示，2023年我国总体医疗机构他汀类药物销售额近120亿元，在经历过集采后，近年来整体市场恢复平稳，不同类他汀药物的渠道销售额分布和企业竞争格局特征各异。补充说明*本文所述他汀类药物市场范围（按照药物解剖学、治疗学及化学分类法ATC编码）：C10A1。*中国医疗机构：包括两个医院渠道（城市医院、县域医院）和两个基层医疗机构渠道（社区卫生中心、乡镇卫生院）。三代他汀类药物，市场规模近120亿元作为降脂药领域的主角，他汀类药物经历过三代技术更迭，主要包括：第一代洛伐他汀、普伐他汀、辛伐他汀；第二代氟伐他汀；以及第三代阿托伐他汀、瑞舒伐他汀和匹伐他汀。根据法伯全渠道数据显示，2023年我国总体医疗机构他汀类药物市场规模达119.3亿元，同比降低1.7%，整体市场在经历过前几轮国家带量采购的冲击后已逐渐恢复平稳。分渠道来看，近年来社区卫生中心渠道销售占比稳步提升，到2023年已达21.4%，超过县域医院（图1）。社区卫生中心是逐步实现基层首诊、双向转诊、建立并完善分级诊疗模式的重要环节，也是加强基层医疗建设的最大受益者，在对慢性病的诊断、治疗和管理方面渠道潜力巨大。图1-2021-2023年总体医疗机构他汀类药物销售额及渠道分布数据来源：法伯全渠道数据在各类他汀药物中，分别于1996年和2003年获得美国FDA批准上市的阿托伐他汀和瑞舒伐他汀，凭借其在降脂效果和药物安全性方面的优势，逐渐占据较大的市场份额。法伯数据显示，2023年上述两类药物在各个销售渠道的份额均排名前两位，尤其是在县域医院，合计占比达87.1%。增速方面，近年来增速最快的是匹伐他汀，2021-2023年复合增长6.5%（图2）。图2-2023年各类他汀药物分渠道销售额占比及增速数据来源：法伯全渠道数据外资排名靠前，内资主导乡镇卫生院渠道从内外资企业竞争格局来看，2021-2023年外资企业在他汀类药物领域整体份额稳定占优，2023年达63.1%。分渠道来看，外资在城市医院、县域医院和社区卫生中心渠道占比均高于50%，而在乡镇卫生院份额则明显低于内资（图3）。图3-2021-2023年他汀类药物市场内外资企业销售额占比及增速数据来源：法伯全渠道数据进一步关注他汀类药物市场的头部企业，根据法伯全渠道数据显示，2023年TOP10企业销售额合计占该领域市场的87.2%，增速低于总体市场的增长水平。晖致和阿斯利康两家外资企业以绝对的份额优势位列前二，内资齐鲁制药在排名上升四位后冲进2023年前三，2021-2023年复合增长30.2%。此外，海正药业和东瑞制药排名较前一年无变化（图4）。图4-2023年总体医疗机构他汀类药物市场销售额TOP10企业及增速数据来源：法伯全渠道数据从头部企业的渠道销售额分布来看，晖致、阿斯利康、第一三共、诺华4家外资企业在城市医院的占比高于广阔市场3个渠道，而内资企业则普遍在广阔市场贡献度较高，尤其是北京嘉林药业，其县域医院、社区卫生中心和乡镇卫生院渠道的合计占比达59.5%（图5）。图5-2023年总体医疗机构他汀类药物市场头部企业渠道销售额分布数据来源：法伯全渠道数据各类他汀药物分渠道发展与企业竞争格局目前，他汀类药物市场中共有4个分子被纳入国采，包括第1批的阿托伐他汀和瑞舒伐他汀，第2批的辛伐他汀，以及第3批的匹伐他汀。法伯数据显示，相关品种2023年在我国总体医疗机构他汀类药物市场合计占比达81.5%（图6）。在由集采导致的波动趋于平缓后，2023年不同类型产品在不同药品销售渠道的市场占比如何？已集采他汀药物的企业竞争格局如何？图6-他汀市场VBP品种及2023年在总体医疗机构销售额占比数据来源：法伯整理；法伯全渠道数据除乡镇卫生院外，其他渠道仍由未中标原研主导根据法伯全渠道数据显示，在整个他汀类药物市场中，虽然中标仿制产品在4个医疗机构渠道的销量份额都优势显著，但是受低价影响，其销售额份额在除了乡镇卫生院之外的渠道都不及未中标原研产品。从整体市场份额来看，未中标原研产品在两个医院渠道的销售规模占比均超50%，未中标仿制产品在院内市场空间被挤压的情况下，则趋于在更加下沉的渠道放量，尤其是在乡镇卫生院，市场份额达35%（图7）。图7-2023年各渠道不同类他汀产品销售额及销量分布数据来源：法伯全渠道数据已纳入国采他汀药物竞争格局及渠道分布各异关注已经纳入集采的几个他汀类药物，发现其企业竞争格局各异。法伯数据显示，2023年阿托伐他汀未中标原研晖致仍独揽过半市场（68.5%），排名第2-4位的齐鲁制药、乐普医疗和福建东瑞制药均为第1批集采中标企业。渠道分布方面，除了晖致之外，其他企业均是在整体广阔市场的市场份额高于城市医院（图8）。图8-2023年阿托伐他汀市场企业竞争格局及渠道销售额分布数据来源：法伯全渠道数据同为第1批集采品种的瑞舒伐他汀，到2023年过半市场（68.5%）也由未中标原研阿斯利康占据，且其销售额主要分布在城市医院渠道（63%）。其余排名靠前的仿制药企京新药业、海正药业和正大天晴均为集采中标企业，其中京新药业更加重视在社区卫生中心布局，海正药业和正大天晴则分别是乡镇卫生院和县域医院渠道贡献度较高（图9）。图9-2023年瑞舒伐他汀市场企业竞争格局及渠道销售额分布数据来源：法伯全渠道数据不同于阿托伐他汀和瑞舒伐他汀，第2-3批集采品种辛伐他汀和匹伐他汀的市场则主要由仿制药企主导。尤其是两次均中标的京新药业，分别以41.2%和43%的份额优势引领这两类他汀药物市场（图10）。图10-2023年辛伐他汀和匹伐他汀市场企业竞争格局数据来源：法伯全渠道数据普伐他汀或将纳入新一批集采除了上述早已纳入集采的药物，有望纳入未来集采的他汀品种也值得关注。6月下旬，一份关于《第十一批国家组织药品集中采购拟采购药品清单》意见的函在业内流出，预示着新批次国采或启动在即。聚焦他汀药物领域，普伐他汀口服常释剂出现在清单之中。公开信息显示，普伐他汀由日本三共制药（现为第一三共株式会社）研发（商品名：美百乐镇），于1989年首次在日本上市。根据法伯全渠道数据显示，2023年总体医疗机构普伐他汀市场59.1%份额由第一三共占据，内资份额较大的为海正药业和上海现代制药。渠道方面，城市医院贡献较高的是第一三共和上海现代制药，丽珠集团和海正药业则重点在社区卫生中心布局（图11）。据悉，截至2025年6月23日，普伐他汀口服常释剂过评企业数量已达9家，整体与原研形成9+1的竞争格局，最终能否纳入新一批集采，值得持续关注。图11-2023年普伐他汀市场企业竞争格局及渠道销售额分布数据来源：法伯全渠道数据往期精选*点击图片阅读详情*点击图片阅读详情*点击图片阅读详情关于法伯科技Pharbers法伯科技秉持客户第一的理念，近十年专注于为我国医药行业和客户提供数据及数据价值服务，努力提供更可靠、更便捷、更能够支持客户业务发展的医药数据。法伯科技能够有效地解决数据短缺、数据孤岛、数据指标口径不统一等行业痛点，通过提供多元数据治理、数据分析及洞察、数据决策等数据价值的全链条服务，帮助客户进行数据资产管理，最大化数据资产价值。目前法伯科技已经为国内外近百家领先的医药客户提供了数据价值服务，法伯科技的医药市场多渠道数据覆盖核心医院市场、广阔市场以及DTP、电商等新兴零售市场，能够帮助客户监测多渠道市场竞争动态、及时发现和应对市场变化；法伯科技同时提供真实世界数据研究及服务，帮助客户从更加真实、具体和精细的角度去发现业务发展的机会；此外，法伯科技还为客户提供更多基于数据的定制化解决方案，如终端潜力估算、市场销售策略等。联系我们产品/业务咨询请联系：contact@pharbers.com或致电：010-84244216公司地址北京市朝阳区东直门外斜街小关56号四层上海市虹口区星荟中心1座603单元

上市批准带量采购

2025-07-01

·esperion.com

Esperion Appoints Craig Thompson to Board of Directors

ANN ARBOR, Mich., July 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it has appointed Craig Thompson, Chief Executive Officer of Cerevance, to its Board of Directors. Mr. Thompson will serve as an independent director. With Mr. Thompson’s appointment, Esperion’s Board of Directors now comprises eight members. “We are thrilled to welcome Craig to our Board of Directors. With more than two decades of biopharmaceutical industry leadership and a proven track record advancing innovative therapies, Craig brings a wealth of strategic insight and operational expertise that will be invaluable as we continue to expand our impact in cardiovascular and cardiometabolic drug development. His deep understanding of pharmaceutical commercialization and clinical development aligns perfectly with our mission to deliver life-saving solutions to patients worldwide. We look forward to his contributions as we enter our next phase of growth and innovation,” stated Sheldon Koenig, President and CEO of Esperion. "I am honored to join the Board of Esperion, a company at the forefront of transforming cardiovascular disease prevention. With cardiovascular conditions remaining the leading cause of death globally, the need for innovative, proactive solutions has never been greater. I look forward to working alongside this exceptional team to help guide strategic decisions and accelerate the development of impactful, science-driven approaches that can improve and extend lives," said Mr. Thompson. Mr. Thompson has been the Chief Executive Officer and a member of the board of directors at Cerevance, a clinical stage biotechnology company focused on neurodegenerative, psychiatric, and CNS-controlled metabolic disorders, since April 2022. Mr. Thompson is also currently a member of the board of directors of NervGen Pharma Corp, a clinical stage biotechnology company focused on developing therapies for neurotrauma and neurologic diseases. Mr. Thompson was previously President & Chief Executive Officer and a member of the board of directors of Neurana Pharmaceuticals from June 2018 to April 2022. Prior to Neurana, Mr. Thompson was President & CEO of Anthera Pharmaceuticals Inc. Prior to Neurana, Mr. Thompson’s biotechnology leadership experience included serving as Chief Operating Officer for Tetraphase Pharmaceuticals Inc. and as Chief Commercial Officer for Trius Therapeutics, Inc. where he was involved in the $700+ million acquisition of Trius Therapeutics by Cubist Pharmaceuticals, Inc., and led a partnership with Bayer Pharma AG. Before that, Mr. Thompson served in various global and U.S. leadership roles at Pfizer Inc., including Therapeutic Group Leader of Allergy, Respiratory, Pulmonary Vascular Disease and Inflammation; and he ultimately served as Vice President of Marketing for Pfizer’s Specialty Care Business Unit. Previous to Pfizer, Mr. Thompson served in positions of increasing responsibility in global marketing at Merck & Co., where he was in product management for Zocor®, including leading the rollout of the landmark Heart Protection Study. He also was instrumental in the pre-launch planning for Vytorin® and Zetia® as part of the European partnership between Merck and Schering-Plough. Mr. Thompson holds a Bachelor of Commerce degree from McMaster University and an MBA from the University of Notre Dame. 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 marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, 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

高管变更并购上市批准

100 项与辛伐他汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00434	辛伐他汀	C10AA01	DB00641

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
V型高脂蛋白血症	中国	杭州默沙东制药有限公司	1997-01-01
冠状动脉疾病	美国	Organon & Co.	1991-12-23
高脂血症	日本	Organon & Co.	1991-10-04
II型高脂蛋白血症	日本	Organon & Co.	1991-10-04
冠心病	澳大利亚	Organon Pharma Pty Ltd.	1991-09-12
杂合子家族性高胆固醇血症	澳大利亚	Organon Pharma Pty Ltd.	1991-09-12
高胆固醇血症	澳大利亚	Organon Pharma Pty Ltd.	1991-09-12
脑卒中	澳大利亚	Organon Pharma Pty Ltd.	1991-09-12

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
糖尿病	临床3期	-	Organon & Co.	2006-09-01
家族性混合型高脂血症	临床3期	-	Merck Sharp & Dohme Corp.	2006-01-24
原发性高胆固醇血症	临床3期	-	Organon & Co.	2002-09-01
合并高脂血症	临床3期	-	Organon & Co.	2002-05-01
2型糖尿病	临床3期	-	Organon & Co.	2001-12-01
纯合子家族性高胆固醇血症	临床3期	-	Organon & Co.	2000-05-03
急性冠状动脉综合征	临床3期	-	Organon & Co.	1999-11-01
胸痛	临床3期	-	Organon & Co.	1999-11-01
心肌梗塞	临床3期	英国	Merck Sharp & Dohme Corp.	1998-07-01
颈动脉狭窄	临床2期	-	Merck Sharp & Dohme Corp.	2009-04-01

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临床结果

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分期

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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


NCT04301271 (Pubmed \| JAMA Psychiatry)	临床2期	重度抑郁症 \| 肥胖追加	161	Simvastatin 40 mg/day	夢餘鏇憲範膚膚憲糧願(廠簾選遞網鑰範顧糧廠) = 廠觸醖築獵觸憲製醖遞膚鬱膚壓壓鑰選簾壓積 (鬱衊遞繭壓簾簾艱遞衊, -2.08 ~ 3.02)	不佳	2025-06-04
				Placebo	鑰艱鏇觸鹽簾襯構遞鑰(糧壓齋網繭艱獵製鑰積) = 鬱鏇遞獵淵積憲網餘鬱膚艱襯觸築醖鏇網製選 (鹹鏇齋觸膚鹹餘範壓醖, -0.28 ~ 1.42)
NCT00678743 (CTgov)	临床4期	血脂障碍	17	simvastatin+Omacor	遞蓋淵積醖網網窪醖壓(齋蓋繭願網淵糧獵壓網) = 積構襯鹽艱鹽廠範願選構鬱範選築鬱鑰構遞繭 (選觸獵構糧網襯膚淵顧, 範衊積膚壓鑰醖顧廠製 ~ 鹹艱選鑰壓壓艱夢選鏇) 更多	-	2025-05-29
AACR2025	N/A	结直肠癌	-	SIM-LNPs-FA	壓窪糧簾範艱糧簾廠鑰(餘繭築範獵醖簾齋構繭) = 廠鑰製範襯範鑰簾願顧構簾鏇齋鏇艱觸衊獵餘 (醖蓋艱艱遞衊蓋憲壓構 ) 更多	-	2025-04-28
				SIM-SMEDDS	壓窪糧簾範艱糧簾廠鑰(餘繭築範獵醖簾齋構繭) = 壓鏇壓壓構夢簾鬱鹹餘構簾鏇齋鏇艱觸衊獵餘 (醖蓋艱艱遞衊蓋憲壓構 ) 更多
NCT02968810 (CTgov)	临床2期	肝细胞癌 \| 纤维化 \| 肝硬化	52	Computed Tomography+simvastatin (Group I (Simvastatin))	積淵廠憲廠選糧廠窪選(齋淵簾憲鑰鏇衊醖鹹窪) = 構網膚醖衊窪繭願艱鬱鬱膚積鏇糧鬱醖淵鹹鹽 (製遞觸觸願齋構願築鏇, 1.00) 更多	-	2025-04-15
				Computed Tomography (Group II (Placebo))	積淵廠憲廠選糧廠窪選(齋淵簾憲鑰鏇衊醖鹹窪) = 製網窪衊齋構窪鬱鏇憲鬱膚積鏇糧鬱醖淵鹹鹽 (製遞觸觸願齋構願築鏇, 0.11) 更多
NCT03780673 (Pubmed \| JAMA)	临床3期	失代偿性肝硬化	237	Simvastatin 20 mg/d + Rifaximin 1200 mg/d	構糧鬱鬱選窪鹽築鏇積(廠衊鹽遞膚鑰廠積簾鏇): HR = 0.75 (95% CI, 0.43 ~ 1.32) 更多	不佳	2025-03-11
				Placebo
ACTRN12617001087347 (ASCO_GI2025)	临床2期	直肠癌新辅助	135	Simvastatin 40mg	簾願衊構構窪廠鑰範觸(選廠繭積網築簾窪窪餘) = 鏇獵鏇鹹構廠餘選觸憲願遞積遞觸鬱築餘壓構 (襯鹹夢衊艱獵鬱製鬱網 ) 更多	积极	2025-01-23
				Placebo	簾願衊構構窪廠鑰範觸(選廠繭積網築簾窪窪餘) = 築艱蓋齋願顧艱齋廠築願遞積遞觸鬱築餘壓構 (襯鹹夢衊艱獵鬱製鬱網 ) 更多
ISRCTN12940165 (Pubmed \| Clin Exp Dent Res) 人工标引	N/A	牙髓坏死	38	modified 3Mix-Simvastatin combinationSimvastatinix-Simvastatin combination (Conventional pulpectomy)	鬱膚鹽衊鹽衊選網蓋艱(獵鬱選選製窪觸鬱鹽願) = 遞範願獵糧餘選艱艱鏇艱膚壓餘壓淵獵顧網繭 (構淵構襯夢鬱積鑰網築 )	积极	2024-04-01
				Non-instrumentation endodontic treatment (NIET) using 3Mixtatin	鬱膚鹽衊鹽衊選網蓋艱(獵鬱選選製窪觸鬱鹽願) = 壓膚蓋鹹襯淵衊觸獵齋艱膚壓餘壓淵獵顧網繭 (構淵構襯夢鬱積鑰網築 )
NCT04638400 (CTgov)	临床4期	炎症 \| 动脉粥样硬化 \| 肥胖 ... 更多	10	Simvastatin 40mg (Simvastatin)	鬱艱範廠獵鬱窪襯獵鏇(鏇觸夢鑰衊齋夢憲鹽糧) = 鏇憲壓糧構齋獵蓋齋淵餘製淵顧繭鏇選積鑰鬱 (範遞積憲觸淵鹹鏇蓋鑰, 11) 更多	-	2024-01-23
				Ezetimibe 10mg (Ezetimibe)	鬱艱範廠獵鬱窪襯獵鏇(鏇觸夢鑰衊齋夢憲鹽糧) = 醖鹽構憲衊繭衊積窪餘餘製淵顧繭鏇選積鑰鬱 (範遞積憲觸淵鹹鏇蓋鑰, 7) 更多
NCT02735707 (REMAP-CAP, Pubmed \| N Engl J Med)	临床3期	新型冠状病毒感染	2,684	Simvastatin 80 mg daily	膚觸構願夢廠膚積築鹽(鏇鏇淵鹽繭觸網積醖鹽) = 築鏇齋廠廠窪構鑰鏇鏇獵齋簾淵衊蓋餘餘蓋壓 (醖齋遞範鑰築遞淵鹹膚, 0.95 ~ 1.32)	不佳	2023-12-21
NCT04514029 (ASH2023)	早期临床1期	Carney复合症	15	Simvastatin 40 mg + Intrathecal Dexamethasone	簾獵簾夢淵醖構鹽醖鑰(廠獵廠鏇襯襯顧觸鬱齋) = 蓋願廠淵夢願膚選憲簾網膚鏇鏇繭鬱廠糧顧廠 (遞構鹽鬱壓鏇選繭鬱鹽 )	-	2023-12-10