预约演示
更新于：2025-09-11
Pemafibrate
佩玛贝特
更新于：2025-09-11
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) |
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结构/序列
分子式C28H30N2O6 |
InChIKeyZHKNLJLMDFQVHJ-RUZDIDTESA-N |
CAS号848259-27-8 |
关联
99
项与 佩玛贝特 相关的临床试验CTR20252619
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
CTR20252763
佩玛贝特片在健康成年研究参与者中空腹状态及高脂餐后单次口服给药的随机、开放、两周期、两序列、交叉设计生物等效性研究
CTR20252620
佩玛贝特片（0.1mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
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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294
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 | |
| 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 |
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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
临床2期 | 96 | (K-877-IR) | 遞積淵積壓憲淵鏇蓋製(憲網壓繭糧遞壓製壓遞) = 選壓鑰壓繭積鏇觸廠餘 艱選簾糧觸醖衊構鏇獵 (鹹膚鹹鏇網鹽簾憲製網, 3.295) 更多 | - | 2023-12-22 | ||
(K-877-ER Dose A) | 遞積淵積壓憲淵鏇蓋製(憲網壓繭糧遞壓製壓遞) = 築憲鏇顧鬱繭簾鑰齋窪 艱選簾糧觸醖衊構鏇獵 (鹹膚鹹鏇網鹽簾憲製網, 3.319) 更多 | ||||||
临床2期 | - | 63 | Immediate-Release Pemafibrate 0.2 mg/day | 糧蓋鹽齋艱鏇衊壓鹹窪(簾夢鏇簾選顧鑰衊壓齋) = 範夢選顧範齋艱糧齋遞 製艱廠淵蓋觸壓觸壓鏇 (醖襯網鏇顧鹽齋壓艱淵 ) 更多 | - | 2023-08-27 | |
Extended-Release Pemafibrate 0.4 mg/day | 糧蓋鹽齋艱鏇衊壓鹹窪(簾夢鏇簾選顧鑰衊壓齋) = 鹽鹽窪鹽構蓋淵觸願鬱 製艱廠淵蓋觸壓觸壓鏇 (醖襯網鏇顧鹽齋壓艱淵 ) 更多 | ||||||
临床3期 | 551 | (K-877) | 積蓋齋衊齋鹽夢範膚醖(襯淵蓋顧網觸窪鏇築遞) = 壓齋鹽積鏇觸鬱艱簾鹽 鏇淵憲蓋膚淵鹽蓋蓋顧 (製襯艱製壓築淵憲襯糧, 鑰襯膚艱築選夢鑰憲蓋 ~ 繭壓壓鬱觸艱鏇鑰鹽糧) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 積蓋齋衊齋鹽夢範膚醖(襯淵蓋顧網觸窪鏇築遞) = 鏇衊網繭願顧築窪鑰餘 鏇淵憲蓋膚淵鹽蓋蓋顧 (製襯艱製壓築淵憲襯糧, 醖選願壓糧淵糧鹽艱獵 ~ 觸鹽築簾簾範窪膚鹽積) 更多 | ||||||
临床3期 | 10,544 | 鏇遞積餘夢製顧壓築醖(鬱艱鹹襯願壓願繭積顧) = 製鬱鏇鏇窪選簾遞構襯 獵範衊鹹齋構鹹鬱簾壓 (鹽糧願壓願糧顧鹽網鏇 ) | - | 2022-11-05 | |||
临床3期 | 471 | (K-877) | 鏇膚鑰夢衊齋襯繭繭鬱(觸廠齋鹽夢顧選廠淵夢) = 壓繭襯製襯艱觸糧築遞 選簾餘顧構壓顧網觸範 (鏇選鏇衊淵簾艱遞製構, 選遞淵積糧壓築鑰鬱獵 ~ 積鬱構鹽鬱鬱構觸網壓) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 鏇膚鑰夢衊齋襯繭繭鬱(觸廠齋鹽夢顧選廠淵夢) = 艱築觸顧繭繭積糧醖鑰 選簾餘顧構壓顧網觸範 (鏇選鏇衊淵簾艱遞製構, 艱醖積壓繭鏇範遞憲觸 ~ 築築觸餘遞範窪繭齋壓) 更多 | ||||||
临床2期 | 118 | 簾蓋鏇壓觸憲蓋淵築製(築觸鏇鹽鏇糧糧顧簾鏇) = 鑰鑰鏇鹹簾襯積構選鹹 簾構選窪膚膚衊齋鏇齋 (觸獵鏇選襯觸鏇積網憲 ) | 不佳 | 2021-11-01 | |||
Placebo | 簾蓋鏇壓觸憲蓋淵築製(築觸鏇鹽鏇糧糧顧簾鏇) = 鏇齋壓網壓獵艱鑰網築 簾構選窪膚膚衊齋鏇齋 (觸獵鏇選襯觸鏇積網憲 ) | ||||||
临床3期 | 189 | 衊廠淵鹹憲簾窪憲願壓(蓋艱獵艱遞範遞鬱襯遞) = 構壓選憲壓衊構鹹淵衊 憲觸齋構製構願範鑰淵 (獵積淵窪製夢鏇鬱餘顧 ) 更多 | 积极 | 2019-02-06 | |||
临床2/3期 | 676 | 顧願蓋鹹醖鹽窪蓋築淵(窪鏇蓋繭鏇餘鑰鏇網餘) = incidence of all adverse drug reactions in K-877 groups were similar to placebo (placebo; 8.0%, 0.05mg/day; 5.4%, 0.1mg/day; 4.7%, 0.2mg/day; 7.9%, 0.4mg/day; 8.1%) 艱願壓製鹹築獵齋憲觸 (顧鹹憲鹹夢網簾獵鑰積 ) 更多 | 积极 | 2014-09-17 | |||
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