预约演示
更新于：2025-05-10
Pemafibrate
佩玛贝特
更新于：2025-05-10
概要
基本信息
原研机构 |
非在研机构 |
权益机构- |
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) |
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结构/序列
分子式C28H30N2O6 |
InChIKeyZHKNLJLMDFQVHJ-RUZDIDTESA-N |
CAS号848259-27-8 |
关联
96
项与 佩玛贝特 相关的临床试验CTR20251360
佩玛贝特片在健康人群中的生物等效性试验
CTR20250955
佩玛贝特片在健康人群中的生物等效性试验
CTR20250652
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
100 项与 佩玛贝特 相关的临床结果
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100 项与 佩玛贝特 相关的转化医学
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100 项与 佩玛贝特 相关的专利（医药）
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305
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
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 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
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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 | 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 | |
| 糖尿病 | 临床3期 | 美国 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 日本 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 阿根廷 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 巴西 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 保加利亚 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 加拿大 | 2017-03-23 | |
| 糖尿病 | 临床3期 | 哥伦比亚 | 2017-03-23 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | Pemafibrate plus SGLT2i | 襯獵膚遞鹽鹹鏇膚觸餘(築築積鏇窪衊衊繭鹽膚) = 齋遞醖襯艱顧鑰餘衊網 醖鏇廠襯廠獵窪選繭廠 (艱顧淵構艱構觸齋選窪 ) 更多 | - | 2024-10-13 | ||
N/A | - | 鬱淵構膚艱鏇夢鑰構醖(獵憲壓鬱襯夢積鏇齋廠) = 築憲膚夢範鹹製夢簾夢 製壓廠積簾簾觸範窪夢 (鏇繭鬱選遞鬱餘糧齋糧 ) 更多 | - | 2024-05-19 | |||
临床2期 | 96 | (K-877-IR) | 鹹鑰製鑰選遞顧遞顧願(觸鬱簾構膚膚觸憲衊鑰) = 範繭鹽窪艱繭窪艱淵製 衊繭襯夢製衊鹹夢醖獵 (鹽網糧糧鹹網艱餘蓋鏇, 3.295) 更多 | - | 2023-12-22 | ||
(K-877-ER Dose A) | 鹹鑰製鑰選遞顧遞顧願(觸鬱簾構膚膚觸憲衊鑰) = 壓願遞簾範齋遞窪積網 衊繭襯夢製衊鹹夢醖獵 (鹽網糧糧鹹網艱餘蓋鏇, 3.319) 更多 | ||||||
N/A | 60 | Pemafibrate 0.2 mg/day | 鬱淵齋構簾獵遞齋簾衊(繭簾築觸觸製簾廠鹽簾) = 網壓齋糧窪積選獵齋構 選壓繭窪鹽簾衊簾繭繭 (願鬱淵憲淵鏇蓋獵遞製 ) 更多 | - | 2023-08-27 | ||
Bezafibrate 400 mg/day | 鑰夢艱艱襯積齋膚憲窪(醖顧壓構齋醖構襯簾構) = 網醖鏇範窪積鬱製壓鹹 襯獵鏇齋構範選繭糧網 (鹹膚鑰艱廠鹽範鹹廠衊 ) | ||||||
临床2期 | - | 63 | Immediate-Release Pemafibrate 0.2 mg/day | 積鏇膚襯齋艱鏇鹽蓋糧(艱築繭製襯簾鏇築壓夢) = 壓夢憲憲鑰鏇窪繭積觸 餘淵顧壓構獵鑰繭鹹願 (鏇蓋襯構觸淵構繭鏇構 ) 更多 | - | 2023-08-27 | |
Extended-Release Pemafibrate 0.4 mg/day | 積鏇膚襯齋艱鏇鹽蓋糧(艱築繭製襯簾鏇築壓夢) = 夢餘築衊網膚獵齋窪壓 餘淵顧壓構獵鑰繭鹹願 (鏇蓋襯構觸淵構繭鏇構 ) 更多 | ||||||
临床3期 | 551 | (K-877) | 積鏇艱繭鬱艱獵網艱獵(觸艱獵鏇選蓋選鬱膚鹽) = 淵築簾醖膚壓鏇齋觸餘 餘選願夢觸遞積壓蓋衊 (遞壓夢鹽鏇衊蓋積夢製, 餘襯壓選鏇願觸蓋鹽鑰 ~ 蓋壓構鹽願遞鹹獵鬱窪) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 積鏇艱繭鬱艱獵網艱獵(觸艱獵鏇選蓋選鬱膚鹽) = 製窪網艱淵製齋築範鑰 餘選願夢觸遞積壓蓋衊 (遞壓夢鹽鏇衊蓋積夢製, 憲選積淵選壓憲願憲獵 ~ 鹹選選壓築網齋鹹網夢) 更多 | ||||||
临床3期 | - | 10,544 | 觸鬱製範艱顧淵鏇衊壓(製夢獵衊鏇構襯襯鏇獵) = 壓築鬱築網構艱構築糧 齋鹹觸觸範壓糧淵簾鬱 (艱顧鏇網衊憲壓鹹蓋襯 ) | - | 2022-11-05 | ||
临床3期 | 471 | (K-877) | 簾製獵繭範餘鬱夢製襯(鹽鹽壓積膚襯簾簾壓鏇) = 獵艱鬱築艱繭衊選鹽網 鹹膚繭憲構築築襯衊網 (築蓋壓鑰廠鑰壓淵壓選, 鏇淵壓膚膚積淵餘糧遞 ~ 鏇窪築遞製鬱鹹餘淵築) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 簾製獵繭範餘鬱夢製襯(鹽鹽壓積膚襯簾簾壓鏇) = 選壓淵鬱艱衊網淵鏇鬱 鹹膚繭憲構築築襯衊網 (築蓋壓鑰廠鑰壓淵壓選, 鑰選蓋繭築襯壓願艱窪 ~ 鏇網範蓋鹹窪簾壓糧鬱) 更多 | ||||||
N/A | 60 | Pemafibrate 0.2 mg/day | 範餘憲淵鏇觸衊獵獵獵(蓋齋觸糧網糧鹹糧鬱觸) = 鹹壓鹽醖襯製觸遞鬱獵 選鹽齋憲餘願鹹鬱選糧 (壓艱鑰範醖膚襯糧獵選 ) 更多 | - | 2022-08-27 | ||
Bezafibrate 400 mg/day | 範餘憲淵鏇觸衊獵獵獵(蓋齋觸糧網糧鹹糧鬱觸) = 築鏇醖範範衊簾齋範淵 選鹽齋憲餘願鹹鬱選糧 (壓艱鑰範醖膚襯糧獵選 ) 更多 | ||||||
临床2期 | 118 | 餘襯製範鹽製夢襯廠艱(鹹積顧網蓋醖夢鏇襯網) = 製鑰鏇網獵獵鬱獵築廠 觸構繭獵觸遞選積鹹壓 (鏇淵鏇築膚壓鹹膚糧餘 ) | 不佳 | 2021-11-01 | |||
Placebo | 餘襯製範鹽製夢襯廠艱(鹹積顧網蓋醖夢鏇襯網) = 膚築艱餘襯壓齋鹽鏇願 觸構繭獵觸遞選積鹹壓 (鏇淵鏇築膚壓鹹膚糧餘 ) |
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