A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.

开始日期2025-06-04

申办/合作机构

Roche Holding AG

ChiCTR2400084812

/ RecruitingN/AIIT

A randomized, double-blind, placebo-controlled, dual-center clinical study to evaluate the efficacy and safety of pitavastatin calcium dispersible tablets in the treatment of active systemic lupus erythematosus

开始日期2024-10-31

申办/合作机构-

CTR20242862

/ TerminatedN/A

匹伐他汀钙片在健康受试者中的单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验

主要目的：以四川赛卓药业股份有限公司的匹伐他汀钙片（规格：2mg）为受试制剂，以Kowa Company,Ltd.的匹伐他汀钙片（商品名：力清之®（LIVALO KOWA ®），规格：2mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2024-08-01

申办/合作机构

四川赛卓药业股份有限公司

100 项与匹伐他汀钙相关的临床结果

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100 项与匹伐他汀钙相关的转化医学

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100 项与匹伐他汀钙相关的专利（医药）

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项与匹伐他汀钙相关的文献（医药）

2025-04-01·ACTA PHARMACOLOGICA SINICA

Ivacaftor, a CFTR potentiator, synergizes with osimertinib against acquired resistance to osimertinib in NSCLC by regulating CFTR-PTEN-AKT axis

Article

作者: Fang, Liang-Jie ; Zeng, Chen-Ming ; Ge, Fu-Jing ; Qu, Jing-Jing ; Li, Yue-Kang ; Qian, Mei-Jia ; Zhou, Jian-Ya ; Yang, Bo ; Li, Yong-Hao ; Zhu, Hong ; He, Qiao-Jun ; Liu, Xiang-Ning ; Lu, Jin-Jian ; Zheng, Ming-Ming

Osimertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), has demonstrated significant clinical benefits in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). However, inevitable acquired resistance to osimertinib limits its clinical utility, and there is a lack of effective countermeasures. Here, we established osimertinib-resistant cell lines and performed drug library screening. This screening identified ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, as a synergistic enhancer of osimertinib-induced anti-tumor activity both in vitro and in vivo. Mechanistically, ivacaftor facilitated the colocalization of CFTR and PTEN on the plasma membrane to promote the function of PTEN, subsequently inhibiting the PI3K/AKT signaling pathway and suppressing tumor growth. In summary, our study suggests that activating CFTR enhances osimertinib-induced anti-tumor activity by regulating the PTEN-AKT axis. Furthermore, ivacaftor and osimertinib constitute a potential combination strategy for treating osimertinib-resistant EGFR-mutated NSCLC patients.

2025-03-01·JAMA Cardiology

Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV

Article

作者: Grinspoon, Steven K. ; Fichtenbaum, Carl J. ; deFilippi, Christopher ; Foldyna, Borek ; Diggs, Marissa R. ; Douglas, Pamela S. ; Sadreyev, Ruslan ; McCallum, Sara ; Lu, Michael T. ; Curran, Adrian ; Eckard, Allison Ross ; Currier, Judith ; Malvestutto, Carlos D. ; Fitch, Kathleen V. ; Karady, Julia ; Bloomfield, Gerald S. ; Aberg, Judith A. ; Mayrhofer, Thomas ; Kolossváry, Márton ; Taron, Jana ; Centinbas, Murat ; Zanni, Markella V. ; Ribaudo, Heather J. ; Schnittman, Samuel R.

Importance:

In a mechanistic substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) randomized clinical trial, pitavastatin reduced noncalcified plaque (NCP) volume, but specific protein and gene pathways contributing to changes in coronary plaque remain unknown.

Objective:

To use targeted discovery proteomics and transcriptomics approaches to interrogate biological pathways beyond low-density lipoprotein cholesterol (LDL-C), relating statin outcomes to reduce NCP volume and promote plaque stabilization among people with HIV (PWH).

Design, Setting, and Participants:

This was a post hoc analysis of the double-blind, placebo-controlled, REPRIEVE randomized clinical trial. Participants underwent coronary computed tomography angiography (CTA), plasma protein analysis, and transcriptomic analysis at baseline and 2-year follow-up. The trial enrolled PWH from April 2015 to February 2018 at 31 US research sites. PWH without known cardiovascular diseases taking antiretroviral therapy and with low to moderate 10-year cardiovascular risk were eligible. Data analyses were conducted from October 2023 to February 2024.

Intervention:

Oral pitavastatin calcium, 4 mg per day.

Main Outcomes and Measures:

Relative change in plasma proteomics, transcriptomics, and noncalcified plaque volume among those receiving treatment vs placebo.

Results:

Among 558 individuals (mean [SD] age, 51 [6] years; 455 male [82%]) included in the proteomics assessment, 272 (48.7%) received pitavastatin and 286 (51.3%) received placebo. After adjusting for false discovery rates, pitavastatin increased abundance of procollagen C-endopeptidase enhancer 1 (PCOLCE), neuropilin 1 (NRP-1), major histocompatibility complex class I polypeptide-related sequence A (MIC-A) and B (MIC-B), and decreased abundance of tissue factor pathway inhibitor (TFPI), tumor necrosis factor ligand superfamily member 10 (TRAIL), angiopoietin-related protein 3 (ANGPTL3), and mannose-binding protein C (MBL2). Among these proteins, the association of pitavastatin with PCOLCE (a rate-limiting enzyme of collagen deposition) was greatest, with an effect size of 24.3% (95% CI, 18.0%-30.8%; P &lt; .001). In a transcriptomic analysis, individual collagen genes and collagen gene sets showed increased expression. Among the 195 individuals with plaque at baseline (88 [45.1%] taking pitavastatin, 107 [54.9%] taking placebo), changes in NCP volume were most strongly associated with changes in PCOLCE (%change NCP volume/log2-fold change = −31.9%; 95% CI, −42.9% to −18.7%; P &lt; .001), independent of changes in LDL-C level. Increases in PCOLCE related most strongly to change in the fibro-fatty (&lt;130 Hounsfield units) component of NCP (%change fibro-fatty volume/log2-fold change = −38.5%; 95% CI, −58.1% to −9.7%; P = .01) with a directionally opposite, although nonsignificant, increase in calcified plaque (%change calcified volume/log2-fold change = 34.4%; 95% CI, −7.9% to 96.2%; P = .12).

Conclusions and Relevance:

Results of this secondary analysis of the REPRIEVE randomized clinical trial suggest that PCOLCE may be associated with the atherosclerotic plaque stabilization effects of statins by promoting collagen deposition in the extracellular matrix transforming vulnerable plaque phenotypes to more stable coronary lesions.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02344290

2025-01-01·Frontiers in Cardiovascular Medicine

Familial hypercholesterolaemia with early-onset coronary artery disease and recurrent in-stent restenosis associated with the LDLR gene c.428G>A mutation: a case report.

Article

作者: Li, Hui ; Huang, Jian ; Zhang, Wei ; Zhu, Jing ; Zhang, Chengpeng

Background:

Familial hypercholesterolaemia (FH) is characterised by significantly elevated low-density lipoprotein cholesterol (LDL-C) levels and early-onset coronary artery disease. Additionally, clopidogrel resistance is observed in approximately 30%-50% of individuals globally. Among FH patients with early-onset coronary artery disease, inadequate LDL-C management and suboptimal antiplatelet therapy after stent implantation are key factors contributing to recurrent in-stent restenosis (ISR).

Case presentation:

A 65-year-old male with a history of coronary artery disease (CAD), hyperlipidemia, and prior angioplasty presented to our institution with exacerbation of angina symptoms. The patient's CAD was initially diagnosed at age 52 (early-onset), with subsequent coronary angiography performed at Lianshui County Hospital. Coronary angiography confirmed coronary artery disease, prompting percutaneous coronary intervention (PCI) with stent placement: one in the right coronary artery and another in the left circumflex artery. Despite receiving standard antiplatelet (aspirin enteric-coated tablets 100 mg, clopidogrel 75 mg) and lipid-lowering therapy (pitavastatin calcium 2 mg), his LDL-C levels remained poorly controlled, and chest pain recurred. At the age of 62 and 65, he developed ISR with additional coronary artery lesions, necessitating balloon angioplasty. FH gene sequencing and clopidogrel resistance testing found he have a heterozygous LDL receptor (LDLR) gene mutation (c.428G>A, p.Cys143Tyr) and a clopidogrel genotype of CYP2C19 *1/*2. Based on these findings, his antiplatelet and lipid-lowering therapies were adjusted (aspirin 100 mg, clopidogrel 150 mg, rosuvastatin 10 mg, ezetimibe 10 mg and alirocumab 150 mg biweekly). Follow-up revealed that his LDL-C levels reached target values, and he remained asymptomatic. One year later, coronary angiography showed no disease progression, and the patient experienced no recurrence of chest pain. This case highlights the efficacy of precision treatment.

Conclusions:

For FH patients with early-onset CAD who are intolerant to ticagrelor, early implementation of FH genetic sequencing and clopidogrel genotyping is critical for personalised treatment.

项与匹伐他汀钙相关的新闻（医药）

2025-07-15

·米内网

【重磅】信立泰1类新药来袭，抢攻240亿蓝海

精彩内容近日，信立泰公告称，公司引进的创新基因编辑药物YOLT-101注射液获批临床，用于治疗杂合子型家族性高胆固醇血症（HeFH）。米内网数据显示，近年来中国三大终端六大市场（统计范围详见本文末）血脂调节剂销售额均超过200亿元。YOLT-101注射液是一款靶向PCSK9碱基编辑药物，拟开发的适应症包括家族性高胆固醇血症等。与现有的PCSK9抗体、siRNA药物等治疗方法相比，YOLT-101可在DNA水平编辑PCSK9基因的单个碱基，降低靶蛋白表达。2024年8月，信立泰公告称，拟与尧唐生物签订协议，获得YOLT-101在中国大陆区域的独家许可权益，总交易金额近10.35亿元；2025年4月，YOLT-101注射液的临床申请获得CDE承办受理，同年7月获批临床，用于治疗杂合子型家族性高胆固醇血症（HeFH）。目前国内常用的血脂调节剂主要包括他汀类药物、贝特类药物、胆固醇吸收抑制剂、PCSK9抑制剂及其他降脂药。米内网数据显示，近年来中国三大终端六大市场血脂调节剂（化药+生物药）销售额均超过200亿元，且呈逐年上涨态势。近年来中国三大终端六大市场血脂调节剂（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库在2025年第一季度血脂调节剂（化药+生物药）TOP5产品中，阿托伐他汀钙片、瑞舒伐他汀钙片、普伐他汀钠片3款他汀类药物分别位列第一、第二、第五；排位第三的依洛尤单抗注射液是一款PCSK9抑制剂，目前暂无生物类似药获批；排位第四的依折麦布片属于胆固醇吸收抑制剂，2025年第一季度同比增长接近20%。2025Q1中国三大终端六大市场血脂调节剂（化药+生物药）TOP5产品来源：米内网格局数据库在降血脂领域，目前信立泰仅拥有1款产品的生产批文，为匹伐他汀钙片；在研1类新药中，重组全人源抗PCSK9单抗注射液（SAL003）进展最快，高胆固醇血症和混合型高脂血症适应症已步入III期临床。信立泰国内部分在研的降血脂新药来源：米内网综合数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月15日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

临床3期生物类似药siRNA

2025-03-12

·GlobeNewswire-Health Care

ACTG Presents Important Findings from REPRIEVE at CROI 2025

Presentations Address Frailty, Inflammation, Asymptomatic Heart Muscle Damage, and Mental FunctionLOS ANGELES, March 12, 2025 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today presented findings from the REPRIEVE trial about the use of statins among people living with HIV with frailty and the relationship between major adverse cardiovascular events (MACE) and measurements of inflammation and asymptomatic heart muscle damage. These results were shared in two oral abstracts: “Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin Effects” and “Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic Substudy” at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, California. REPRIEVE (The Randomized Trial to Prevent Vascular Events in HIV) was the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of MACE by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. “We are eager to share data from REPRIEVE at CROI about the relationship between frailty and major cardiovascular events, the importance of inflammation and asymptomatic heart muscle damage, and the impact of statin therapy on neurocognition (mental function) and heart failure risk,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “REPRIEVE was a groundbreaking study that has informed a multitude of international guidelines, which now recommend statins to prevent cardiovascular disease in many people living with HIV and we expect that it will continue to generate meaningful findings that improve the care of people living with HIV.” Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin EffectsToday’s presentation examined whether frailty is associated with MACE among people living with HIV and whether statins may prevent MACE across a spectrum of frailty. Researchers found that higher levels of frailty were associated with increased risk of MACE among participants. They also determined that while adults living with HIV and frailty were routinely under-prescribed key preventive therapies such as statins, frailty status did not appear to modify the protective effects of pitavastatin that were seen in the primary trial. While further research is needed, the study concluded that incorporating frailty assessments such as the frailty index may help identify people living with HIV who are at risk of MACE. “The strong association in this analysis between the age-related syndrome of frailty and major adverse cardiovascular events may suggest similar underlying mechanisms and, further, that screening for frailty can help identify the participants at highest risk for cardiovascular events,” said Presenting Author Kristine Erlandson, M.D., University of Colorado Anschutz Medical Campus. “While providers and patients may question the added benefit of statins in patients with numerous comorbidities, the data presented today support the use of pitavastatin among adults living with HIV and frailty.” Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic SubstudyThis secondary analysis presented today assessed for the first time the relationship between coronary plaque and measurements of inflammation and asymptomatic heart muscle damage with MACE. Today’s presentation demonstrated that among participants in REPRIEVE’s mechanistic substudy, individuals with noncalcified coronary plaque (buildup of plaque in the arteries that can cause a heart attack) and higher blood levels of inflammation and heart muscle injury at study entry were at higher risk of having a cardiovascular event over six years of follow up even though they did not have symptoms. In exploratory analyses, plaque and biomarker (blood proteins associated with cardiovascular disease) combinations further improved the accuracy of predicting the risk of MACE beyond traditional risk scores. The data also suggested that the benefit of pitavastatin to prevent MACE may be greater among individuals who have noncalcified coronary plaque and evidence of low-grade myocardial damage, which may precede symptoms. Additional investigation is necessary to determine how pitavastatin can be most effective for these individuals. “These data suggest that key plaque, inflammatory, and asymptomatic heart muscle damage markers are strongly related to MACE, even among people living with HIV who are not experiencing cardiac-related symptoms,” said Presenting Author and Study Chair Steven Grinspoon, M.D, Harvard Medical School and Massachusetts General Hospital. “These data highlight the need for additional studies to identify people living with HIV who might benefit most from statin therapy and to identify new mechanistic pathways to target,” said REPRIEVE Mechanistic Substudy Protocol Chair and Lead Author Michael Lu, M.D., M.P.H., Harvard Medical School and Massachusetts General Hospital. ACTG also presented two posters at CROI reporting on additional REPRIEVE findings: No Evidence of a Detrimental Effect of Pitavastatin on Neurocognitive Function Among People with HIV found no evidence to suggest that pitavastatin impacted neurocognitive function among people living with HIV at low to moderate cardiovascular disease risk, even among those who entered the study with some existing level of impairment.“Concerns about potential detrimental cognitive effects of statins are often raised when considering statin therapy,” said Presenting Author Dr. Erlandson. “The results from this randomized, blinded study, which show no relationship between statin therapy and change in neurocognitive function, should provide reassurance to patients and providers.” Heart Failure Risk and Events In People with HIV: The Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE)” (Gerald Bloomfield, et al.) found that the number of heart failure events among people living with HIV in REPRIEVE was consistent with the low estimated PREVENT (Predicting Risk of Cardiovascular Disease Events) heart failure risk rates. Participants who were Black, female, lived in sub-Saharan Africa, had pre-existing hypertension, and/or elevated body mass were more likely to experience heart failure. REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes, and ACTG (AI068636). It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The study is led by Dr. Grinspoon and Pamela S. Douglas, M.D., Duke University School of Medicine (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D., Harvard School of Public Health (Lead Statistician) and Dr. Lu, who led the Data Coordinating Center. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). To learn more, please visit www.reprievetrial.org. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu

临床研究临床结果

2025-03-04

·米内网

科伦、齐鲁……冲刺口服降脂药首仿！TOP20洗牌，20亿大品种领跑，海正、京新、方盛上榜

精彩内容近期，内服血脂调节剂市场新品不断，北京四环科宝制药的氟伐他汀钠缓释片以仿制4类报产在审。今年以来，内服血脂调节剂已有11个品种（28个受理号）报产在审，科伦药业、齐鲁制药等冲刺首仿。米内网数据显示，内服血脂调节剂（化+生）在2024年Q1-Q3在中国零售药店终端同比增长超过12%，TOP20中，20亿大品种领跑，独家产品暴涨112%，海正药业、京新药业、神奇制药、方盛制药等上榜。大涨12%，晖致、阿斯利康、欧加农位居前三近年中国零售药店终端内服血脂调节剂销售情况（单位：亿元）来源：米内网格局数据库米内网数据显示，内服血脂调节剂（化+生）在近年中国零售药店（城市实体药店和网上药店）终端市场规模稳步增长，均超过50亿元，2024年Q1-Q3同比增长12.37%。其中，城市实体药店是主要销售渠道；网上药店则快速增长，销售额已超过2023年全年。 2024年Q1-Q3中国零售药店终端内服血脂调节剂集团TOP5来源：米内网格局数据库从集团TOP20来看，晖致、阿斯利康、欧加农制药、浙江海正药业、乐普医疗位居前五，方盛制药增速（162.59%）最快，首次晋身TOP20。从治疗小类来看，HMGCoA还原酶抑制剂市场份额最大，占超过8成，其他血脂调节剂则增速最快。从在销品种数量来看，产品超过60个，品牌超过280个。 20亿大品种领跑，独家产品暴涨112%，京新、方盛上榜 2024年Q1-Q3中国零售药店终端内服血脂调节剂产品TOP20（单位：亿元）来源：米内网格局数据库注：销售额不足1亿元以*表示，标红为独家产品产品TOP20中，阿托伐他汀钙片多年来稳居“销冠”宝座，以超20亿元的销售规模领跑，瑞舒伐他汀钙片则紧跟其后。从增速来看，维E三油胶丸（112.05%）是唯一一个翻倍的产品，瑞舒伐他汀钙片（25.49%）、依折麦布片（34.36%）、非诺贝特胶囊（18.10%）、多烯酸乙酯软胶囊（26.75%）、海博麦布片（74.39%）、ω-3脂肪酸乙酯90软胶囊（94.27%）、匹伐他汀钙分散片（29.00%）均有双位数增速。 6个独家品种中，阿托伐他汀钙分散片（广东九瑞科技）、海博麦布片（浙江海正药业）、维E三油胶丸（贵州神奇药业）、匹伐他汀钙分散片（京新药业）在近年均持续增长。 2024年Q1-Q3中国零售药店终端内服血脂调节剂品牌TOP20（单位：亿元）来源：米内网格局数据库注：销售额不足1亿元以*表示品牌TOP20中，晖致的阿托伐他汀钙片和阿斯利康的瑞舒伐他汀钙片销售额均超过10亿元。北京福元医药的阿托伐他汀钙片、浙江海正药业的海博麦布片等5个品牌新上榜，其中，斯洛文尼亚莱柯的瑞舒伐他汀钙片（302.57%）、湖南方盛制药的依折麦布片（162.59%）、贵州神奇药业的维E三油胶丸（112.05%）均增速翻倍。依折麦布片在近年中国零售药店终端保持双位数增速，2024年Q1-Q3销售额已超过3亿元，接近2023年全年。欧加农制药的市场份额最大；湖南方盛制药位居第二，市场份额从2021年不足1%到2024年Q1-Q3超过8%。海博麦布片是浙江海正药业的1类新药，该产品在近年中国零售药店终端市场规模快速扩容，2023年-2024年Q1-Q3分别同比增长289.19%、74.39%，跃升到内服血脂调节剂（化+生）TOP11产品。海正药业表示，海博麦布片被纳入《中国血脂管理指南（基层版2024年）》《糖尿病患者血脂管理中国专家共识（2024版）》《中国慢性冠脉综合征患者诊断及管理指南》，提升其在胆固醇领域的治疗地位，公司将持续加速产品的市场覆盖和准入进程。科伦、齐鲁……猛攻首仿，海正改良型新药来袭今年以来报产在审的内服血脂调节剂来源：米内网中国申报进度（MED）数据库近日，CDE官网显示，北京四环科宝制药的氟伐他汀钠缓释片以仿制4类报产在审。在此之前，齐鲁制药（海南）的瑞舒伐他汀依折麦布片(Ⅰ)、四川科伦药业的瑞舒伐他汀依折麦布片(Ⅰ)等3个产品同日报产。今年以来，内服血脂调节剂已有11个品种（28个受理号）报产在审，瑞舒伐他汀依折麦布片(Ⅰ)和瑞舒伐他汀依折麦布片(Ⅱ)暂无仿制药获批，而瑞舒伐他汀依折麦布片(Ⅰ)竞争最激烈，目前共有20家企业报产在审，其中，齐鲁制药（海南）、四川科伦药业、江西施美药业、山东齐都药业等9家企业均在今年报产。来源：米内网项目进度数据库此外，海博麦布阿托伐他汀钙片为瀚晖制药|浙江海正药业的2.3类改良型新药。资料显示，该产品作为饮食控制以外的辅助治疗，拟用于治疗原发性（杂合子家族性或非家族性）高胆固醇血症或混合性高脂血症，可降低总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、载脂蛋白B（ApoB）水平和甘油三酯(TG)水平。资料来源：米内网数据库、公司公告等注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

申请上市IPO

100 项与匹伐他汀钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01862	匹伐他汀钙	C10AA08	DB08860

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
家族性混合型高脂血症	美国	Kowa Co., Ltd.	2019-05-16
杂合子家族性高胆固醇血症	澳大利亚	Advantage Medical Products LLC	2013-08-27
血脂障碍	中国	Kowa Co., Ltd.	2008-09-28
高脂血症	中国	Kowa Co., Ltd.	2008-09-28
高胆固醇血症	日本	Kowa Co., Ltd.	2003-07-17
II型高脂蛋白血症	日本	Kowa Co., Ltd.	2003-07-17

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
原发性高脂血症	临床3期	美国	Kowa Research Institute, Inc.	2016-01-01
HIV感染	临床1期	美国	Kowa Pharmaceuticals America, Inc.	2012-05-01

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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


NCT01710007 (CTgov)	临床3期	原发性高胆固醇血症 \| 高胆固醇血症	202	Lipitor (Lipitor)	蓋夢夢構膚構齋廠選選(醖鹽獵製獵觸蓋衊膚鬱) = 壓鹽餘齋餘夢襯範齋鹹膚鑰醖製築顧觸醖齋鏇 (鬱餘獵廠鬱憲遞積襯鏇, 12.80) 更多	-	2023-07-17
				1PC002 (1PC002)	蓋夢夢構膚構齋廠選選(醖鹽獵製獵觸蓋衊膚鬱) = 構築構膚艱選醖夢淵夢膚鑰醖製築顧觸醖齋鏇 (鬱餘獵廠鬱憲遞積襯鏇, 17.97) 更多
NCT01695954 (CTgov)	临床1期	高脂血症 \| HIV感染	34	Pitavastatin+Efavirenz (Arm A: (Pitavastatin and Efavirenz))	艱鑰鬱餘顧壓繭鏇糧鑰(顧觸範衊廠襯餘壓壓糧) = 糧衊網衊壓衊製憲構築醖鹹淵鬱餘網衊膚鏇網 (鏇膚簾觸夢襯網鬱鑰範, 5.72) 更多	-	2020-08-11
				Pitavastatin+Darunavir (Arm B: (Pitavastatin and Darunavir))	艱鑰鬱餘顧壓繭鏇糧鑰(顧觸範衊廠襯餘壓壓糧) = 艱選簾蓋憲憲廠獵廠觸醖鹹淵鬱餘網衊膚鏇網 (鏇膚簾觸夢襯網鬱鑰範, 6.24) 更多
NCT00889226 (ESPRIT, CTgov)	临床4期	2型糖尿病 \| 高胆固醇血症	161	Pitavastatin (Pitavastatin Group)	願獵糧鏇構構鏇鹽築艱 = 鹽壓願願選製鹹顧獵顧襯簾鑰鏇觸膚獵觸築衊 (簾壓窪顧觸顧憲襯齋構, 齋簾範顧蓋廠醖齋構廠 ~ 鏇醖憲糧糧鬱淵艱獵鑰) 更多	-	2019-09-17
				Atorvastatin (Atorvastatin Group)	願獵糧鏇構構鏇鹽築艱 = 艱鹽糧觸顧築膚膚觸鬱襯簾鑰鏇觸膚獵觸築衊 (簾壓窪顧觸顧憲襯齋構, 獵鬱選淵構構積艱餘選 ~ 膚鏇顧選襯願構艱顧憲) 更多
NCT01660191 (SPARQ, CTgov)	临床4期	高胆固醇血症	134	Pitavastin 4mg+Rosuvastatin 5mg (Atorvastatin 20mg)	築製觸範艱鏇積願餘簾(衊窪窪衊襯齋膚廠蓋選) = 觸鏇齋壓觸鬱窪艱壓鑰齋淵簾鏇衊築憲憲鑰遞 (淵艱遞餘鬱築觸窪糧製, 224.24) 更多	-	2017-01-18
				Atorvastatin 20mg+Rosuvastatin 5mg (Pitavastatin 4mg)	築製觸範艱鏇積願餘簾(衊窪窪衊襯齋膚廠蓋選) = 遞網糧繭鬱積糧簾糧網齋淵簾鏇衊築憲憲鑰遞 (淵艱遞餘鬱築觸窪糧製, 136.29) 更多
LAMIS-II (ESC2016)	N/A	急性心肌梗塞 diabetic	-	2 mg of pitavastatin	衊構膚築醖遞願遞選衊(鬱鑰鏇積壓憲網鬱鏇壓) = 選衊積壓襯鏇遞餘範觸膚鹹鹽膚鏇糧鏇糧願願 (鬱廠艱夢餘遞築遞齋淵 ) 更多	-	2016-08-30
				4 mg of pitavastatin	衊構膚築醖遞願遞選衊(鬱鑰鏇積壓憲網鬱鏇壓) = 鏇夢範鹽鑰餘繭願窪網膚鹹鹽膚鏇糧鏇糧願願 (鬱廠艱夢餘遞築遞齋淵 ) 更多
NCT01256476 (Pubmed \| Clin Ther)	临床4期	原发性高脂血症 \| 血脂障碍	328	Pitavastatin 4 mg	憲艱繭窪繭衊獵積夢鹹(鑰觸鹹膚衊鬱網積構鏇) = 餘鹽衊襯膚簾淵憲窪觸製艱餘夢糧鏇艱衊憲顧 (網艱繭蓋製襯鹹窪獵繭 )	积极	2014-08-01
				Pravastatin 40 mg	憲艱繭窪繭衊獵積夢鹹(鑰觸鹹膚衊鬱網積構鏇) = 艱襯淵網醖築製鬱鹽憲製艱餘夢糧鏇艱衊憲顧 (網艱繭蓋製襯鹹窪獵繭 )
NCT01301066 (INTREPID, CTgov)	临床4期	血脂障碍 \| HIV感染	252	Pitavastatin (Pitavastatin 4 mg QD)	獵網網鏇願蓋製壓繭襯(蓋夢憲鹽壓鹽鹽廠蓋壓) = 鏇衊衊憲廠齋顧襯廠顧繭繭遞鏇壓鏇壓觸獵顧 (簾膚網顧窪鹽鹹醖艱糧, 25.93) 更多	-	2014-04-29
				Pravastatin (Pravastatin 40 mg QD)	獵網網鏇願蓋製壓繭襯(蓋夢憲鹽壓鹽鹽廠蓋壓) = 窪遞蓋願築選糧遞構齋繭繭遞鏇壓鏇壓觸獵顧 (簾膚網顧窪鹽鹹醖艱糧, 23.91) 更多
INTREPID (IAS2014)	N/A	血脂障碍 \| HIV感染	252	Pitavastatin 4mg	顧齋齋製膚選淵壓襯網(壓遞襯夢齋艱襯壓壓壓) = 鏇鹹積鹽繭廠築窪觸齋選積衊繭艱壓糧憲艱廠 (齋鑰壓淵鹹觸築醖壓齋 )	积极	2014-01-01
				Pravastatin 40mg	顧齋齋製膚選淵壓襯網(壓遞襯夢齋艱襯壓壓壓) = 網糧鑰醖醖網窪夢膚繭選積衊繭艱壓糧憲艱廠 (齋鑰壓淵鹹觸築醖壓齋 )
ISC2013	N/A	脑梗塞 \| 冠状动脉疾病	-	non-EPA-group	築鹹糧願獵齋衊醖窪窪(鑰簾憲選鑰積積餘壓範) = 範衊鹽艱鹽夢簾鹹獵鏇憲壓蓋鹹膚網廠網襯製 (選構衊淵繭範糧鏇觸衊 )	-	2013-02-01
NCT01043094 (CTgov)	临床4期	肾功能不全	16	Pitavastatin 4mg (Pitavastatin 4mg Renal Impaired)	醖製夢蓋鹽廠齋窪遞餘(壓壓鏇醖構觸積鏇觸積) = 壓鏇觸齋願蓋窪積顧遞齋網夢簾遞繭襯醖艱獵 (顧製築築築網鑰鑰憲醖, 39) 更多	-	2012-08-13
				Pitavastatin 4mg (Pitavastatin 4mg Healthy Subjects)	醖製夢蓋鹽廠齋窪遞餘(壓壓鏇醖構觸積鏇觸積) = 壓範襯積糧顧鹽簾艱齋齋網夢簾遞繭襯醖艱獵 (顧製築築築網鑰鑰憲醖, 55) 更多