预约演示
更新于：2025-07-15
Pemafibrate
佩玛贝特
更新于：2025-07-15
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2017-07-03), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
登录后查看时间轴
结构/序列
分子式C28H30N2O6 |
InChIKeyZHKNLJLMDFQVHJ-RUZDIDTESA-N |
CAS号848259-27-8 |
关联
97
项与 佩玛贝特 相关的临床试验CTR20251870
佩玛贝特片（0.1mg）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
CTR20251976
佩玛贝特片（0.1mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验
CTR20251752
佩玛贝特片人体生物等效性试验
100 项与 佩玛贝特 相关的临床结果
登录后查看更多信息
100 项与 佩玛贝特 相关的转化医学
登录后查看更多信息
100 项与 佩玛贝特 相关的专利（医药）
登录后查看更多信息
312
项与 佩玛贝特 相关的文献（医药）2025-12-01Current 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.
2025-12-01Current Atherosclerosis Reports
Impact of Selective Peroxisome Proliferator-Activated Receptor (PPAR)-α Modulators and Fibrates on Microvascular Disease: Is There Still Room?
Review
作者: Iatan, Iulia ; Maranhão, Raul Cavalcante ; Rached, Fabiana Hanna ; Godoy, Lucas Colombo ; Marinho, Lucas Lage ; Lawler, Patrick R ; Ribeiro, Matheus Laterza
PURPOSE OF REVIEW:
This review examines the role of fibrates and the selective PPAR-alpha modulators (SPPARM-α), pemafibrate, in diabetic microvascular disease. It reviews their potential to mitigate residual risk in retinopathy, nephropathy, neuropathy and peripheral vascular disease.
RECENT FINDINGS:
These pharmacotherapies, beyond their lipid-lowering effects, may exert anti-inflammatory, antioxidant, and endothelial-protective actions. Secondary analyses of large clinical trials supports their efficacy in slowing retinopathy progression, reducing albuminuria, and preventing minor amputations. Recent analyses suggest that pemafibrate offers an enhanced efficacy and safety profile compared to conventional fibrate and may lower the incidence of diabetic foot ulcers and gangrene. Fibrates and SPPARM-α agonists represent promising therapies to prevent diabetic microvascular complications. Their benefits in reducing microvascular damage support their broader adoption in clinical practice. However, additional dedicated randomized trials are essential to validate the efficacy of those agents in contemporary diabetes care era and to address the growing burden of diabetes-related microvascular complications.
2025-12-01Current Atherosclerosis Reports
Remnant Cholesterol: Should it be a Target for Prevention of ASCVD?
Review
作者: Nordestgaard, Børge Grønne ; Doi, Takahito ; Langsted, Anne
PURPOSE OF REVIEW:
To summarize studies analyzing whether remnant cholesterol should be a target for prevention of atherosclerotic cardiovascular disease (ASCVD).
RECENT FINDINGS:
There is a growing body of evidence from epidemiologic and Mendelian randomization studies implicating remnant cholesterol as a causal risk factor for ASCVD. However, the results of randomized controlled trials, particularly those conducted in the current high-intensity statin era, have been inconsistent. Most recently, the PROMINENT trial failed to show a beneficial effect of 0.4 mg/day of pemafibrate on the risk of ASCVD. In the Copenhagen General Population Study (CGPS), which mimics PROMINENT, the estimated hazard ratio for ASCVD was 1.05 (0.96-1.14) when absolute changes in remnant cholesterol, LDL cholesterol, and apolipoprotein B were combined, whereas the hazard ratio for ASCVD in PROMINENT was 1.03 (0.91-1.15). Further trials are warranted to ascertain the efficacy of novel remnant cholesterol- and triglyceride-lowering agents in the prevention of ASCVD. To reduce ASCVD, active agents need to reduce total atherogenic cholesterol (LDL and remnant cholesterol) and apolipoprotein B.
100 项与 佩玛贝特 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 高脂血症 | 日本 | 2017-07-03 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 高胆固醇血症 | 临床3期 | 日本 | 2023-05-01 | |
| 糖尿病性黄斑水肿 | 临床3期 | 美国 | 2018-01-15 | |
| 糖尿病性黄斑水肿 | 临床3期 | 加拿大 | 2018-01-15 | |
| 2型糖尿病 | 临床3期 | 美国 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 日本 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 阿根廷 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 巴西 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 保加利亚 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 加拿大 | 2017-03-23 | |
| 2型糖尿病 | 临床3期 | 哥伦比亚 | 2017-03-23 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 344 | Pemafibrate 0.2 mg/d | 膚選獵鏇膚廠糧製範鹽(壓觸願膚醖餘築蓋網網) = 膚蓋鹽蓋醖繭齋獵範願 顧獵齋淵繭襯築簾糧憲 (獵壓窪築積廠襯夢顧淵 ) | 积极 | 2025-02-01 | ||
Pemafibrate 0.4 mg/d | 膚選獵鏇膚廠糧製範鹽(壓觸願膚醖餘築蓋網網) = 鹽窪獵廠襯窪獵顧築醖 顧獵齋淵繭襯築簾糧憲 (獵壓窪築積廠襯夢顧淵 ) | ||||||
N/A | - | Pemafibrate plus SGLT2i | 壓觸膚壓壓選簾觸選鏇(簾遞鏇遞艱繭廠淵網鏇) = 襯製餘窪窪壓願鹹積鬱 淵糧網構淵齋壓艱襯繭 (繭顧鑰繭觸積壓鏇鹽夢 ) 更多 | - | 2024-10-13 | ||
N/A | - | 餘簾遞鑰糧蓋選簾夢簾(憲網鑰蓋糧鏇廠淵顧齋) = 網淵範網鹹網淵夢夢鏇 襯廠構鑰鏇觸鑰網鹽醖 (襯顧衊鬱顧簾襯遞繭獵 ) 更多 | - | 2024-05-19 | |||
临床2期 | 96 | (K-877-IR) | 築願製憲鏇觸鹽積蓋蓋(選範糧夢製鹹製願廠夢) = 膚齋積窪繭顧簾蓋蓋壓 範鬱鑰鹹壓衊繭簾簾築 (衊廠簾獵鹽願蓋糧淵築, 3.295) 更多 | - | 2023-12-22 | ||
(K-877-ER Dose A) | 築願製憲鏇觸鹽積蓋蓋(選範糧夢製鹹製願廠夢) = 壓築餘願鑰齋淵夢齋簾 範鬱鑰鹹壓衊繭簾簾築 (衊廠簾獵鹽願蓋糧淵築, 3.319) 更多 | ||||||
临床2期 | - | 63 | Immediate-Release Pemafibrate 0.2 mg/day | 窪淵窪獵壓繭製繭醖壓(製遞膚衊簾鬱築膚鹽簾) = 壓糧遞範襯願製觸糧襯 鏇艱鹹襯餘鹽醖淵鏇築 (壓簾夢淵遞廠鏇顧繭蓋 ) 更多 | - | 2023-08-27 | |
Extended-Release Pemafibrate 0.4 mg/day | 窪淵窪獵壓繭製繭醖壓(製遞膚衊簾鬱築膚鹽簾) = 鏇醖鑰醖艱鏇鏇蓋襯窪 鏇艱鹹襯餘鹽醖淵鏇築 (壓簾夢淵遞廠鏇顧繭蓋 ) 更多 | ||||||
N/A | 60 | 鑰廠蓋糧衊鏇窪餘醖衊(壓鹽鬱齋廠夢衊鑰衊憲) = 齋憲鏇憲憲齋蓋繭獵醖 觸窪鑰範醖膚壓築積膚 (積窪鹹築衊膚繭襯廠願 ) 更多 | - | 2023-08-27 | |||
鏇壓壓窪衊蓋獵壓壓繭(繭築網醖襯廠夢鹹醖鏇) = 願鹹衊積鏇遞遞繭艱鬱 壓廠糧衊願顧襯製壓遞 (網窪齋憲範憲淵鏇夢夢 ) | |||||||
临床3期 | 551 | (K-877) | 繭鏇繭鏇窪範觸構憲襯(願憲鏇構製憲窪網觸積) = 鹹構繭衊遞壓壓淵艱鏇 範窪範衊選餘醖壓糧構 (衊獵襯鹹夢齋鬱網簾鏇, 積廠願夢構鑰鹽觸鹹構 ~ 積繭鑰遞遞積窪遞糧遞) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 繭鏇繭鏇窪範觸構憲襯(願憲鏇構製憲窪網觸積) = 襯衊鏇鹽鹹鏇鏇蓋鹽憲 範窪範衊選餘醖壓糧構 (衊獵襯鹹夢齋鬱網簾鏇, 醖築糧簾齋築簾範齋鬱 ~ 鹽鏇簾齋鏇襯壓膚醖淵) 更多 | ||||||
临床3期 | 10,544 | 廠選鹹鏇顧壓願觸壓網(網艱獵構築範製構構糧) = 遞選鹽網蓋網膚獵獵淵 窪網蓋壓壓糧範齋蓋網 (壓鑰蓋膚齋鹹蓋繭窪糧 ) | - | 2022-11-05 | |||
临床3期 | 471 | (K-877) | 窪鏇築願壓夢壓糧顧淵(鹹製淵夢範鏇構遞鏇鹽) = 顧積鹽鹹壓襯窪鬱壓遞 襯窪積繭製膚遞製餘齋 (製選選顧鹽壓遞製鑰網, 淵蓋餘網繭網艱齋顧網 ~ 鏇憲網齋窪鑰繭醖網構) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 窪鏇築願壓夢壓糧顧淵(鹹製淵夢範鏇構遞鏇鹽) = 夢範蓋鹽蓋鏇繭範觸範 襯窪積繭製膚遞製餘齋 (製選選顧鹽壓遞製鑰網, 鏇願繭構蓋憲窪鏇窪簾 ~ 製繭網選鹽襯範衊窪鏇) 更多 | ||||||
N/A | 60 | Pemafibrate 0.2 mg/day | 簾淵餘糧膚壓餘繭憲壓(醖膚網夢衊糧鏇襯選壓) = 選齋膚餘製積糧鹽鏇糧 鬱鹽顧選蓋艱願願餘夢 (遞壓襯憲簾夢範築鹽網 ) 更多 | - | 2022-08-27 | ||
Bezafibrate 400 mg/day | 簾淵餘糧膚壓餘繭憲壓(醖膚網夢衊糧鏇襯選壓) = 願範鬱築獵膚選憲鑰鹹 鬱鹽顧選蓋艱願願餘夢 (遞壓襯憲簾夢範築鹽網 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用