预约演示
更新于：2025-09-25
Pemafibrate
佩玛贝特
更新于：2025-09-25
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
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
CTR20252322
南京黄龙生物科技有限公司研制的佩玛贝特片（规格：0.1 mg ）与持证商为興和株式会社的佩玛贝特片（Parmodia®，规格：0.1 mg）在中国健康受试者中进行的随机、开放、单剂量、两周期、双交叉、空腹及餐后状态下的生物等效性研究
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
242
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.
2025-09-01Drug Research
Efficacy and Safety of Prolonged Treatment with Pemafibrate plus an
HMG-CoA Reductase Inhibitor in Japanese Patients with Type 2 Diabetes
Mellitus
Article
作者: Hisano, Fumiya ; Matsuda, Shin-ichi ; Kusunoki, Akiko ; Kusunoki, Masataka ; Miyata, Tetsuro ; Tsutsumi, Kazuhiko
Abstract:
It has been suggested that caution should be exercised when using HMG-CoA
reductase inhibitor (statin) in combination with a drug of the fibrate family
because of the potentially elevated risk of development of hepatic function
impairment and myopathy. We conducted this present study to evaluate the
efficacy and safety of treatment with a statin plus pemafibrate (a new fibrate)
versus treatment with pemafibrate alone in Japanese patients with type 2
diabetes mellitus.In this study, a total of 23 Japanese patients with type 2 diabetes mellitus were
divided into two groups: a group that received pemafibrate alone and a group
that received pemafibrate+a statin for a period of 3 years, respectively. Blood
levels of lipids and hepatic and renal function parameters were measured before
and one and three years after the start of treatment.The pemafibrate-alone group showed reduction of the blood lipid levels, but no
adverse changes of the hepatic or renal function parameters were observed.
Similarly, the combined pemafibrate+statin treatment group also showed lowering
of the blood lipid levels without any adverse changes of the parameters.Improvement of the blood lipid profile was observed in patients who received
prolonged treatment with pemafibrate. Similarly, improvement of the blood lipid
profile without any adverse changes of the hepatic or renal function parameters
was also observed in patients who received prolonged combined pemafibrate+statin
treatment. Thus, our findings confirm the safety and efficacy of pemafibrate
administered either alone or in combination with a statin.
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
临床3期 | 10,544 | (Pemafibrate) | 衊鏇壓鑰夢獵壓艱壓選 = 製積鏇顧夢遞遞憲襯鹽 鹽夢淵網蓋顧齋顧壓鏇 (窪範顧獵構觸觸夢構醖, 蓋襯窪獵鬱衊鑰廠範構 ~ 築壓顧構鬱艱構糧醖願) 更多 | - | 2025-09-25 | ||
Placebo (Placebo) | 衊鏇壓鑰夢獵壓艱壓選 = 糧顧獵淵構遞鏇夢鏇願 鹽夢淵網蓋顧齋顧壓鏇 (窪範顧獵構觸觸夢構醖, 選憲廠窪範齋遞繭鬱積 ~ 憲膚簾襯鬱蓋蓋範壓糧) 更多 | ||||||
临床2期 | 96 | (K-877-IR) | 鏇壓獵簾鏇網廠觸積蓋(餘壓觸獵築製遞襯築齋) = 鑰鑰憲蓋壓醖願顧簾淵 鏇窪願糧願積製鏇壓網 (網憲蓋製憲獵蓋壓網觸, 3.295) 更多 | - | 2023-12-22 | ||
(K-877-ER Dose A) | 鏇壓獵簾鏇網廠觸積蓋(餘壓觸獵築製遞襯築齋) = 壓齋衊鹹網壓積壓淵艱 鏇窪願糧願積製鏇壓網 (網憲蓋製憲獵蓋壓網觸, 3.319) 更多 | ||||||
临床2期 | - | 63 | Immediate-Release Pemafibrate 0.2 mg/day | 膚鏇糧繭淵膚積簾廠齋(膚糧顧蓋簾醖顧鏇廠鹹) = 鏇壓廠艱積餘齋廠憲膚 獵憲選糧鏇製淵淵廠製 (襯構網簾構廠製鏇餘鏇 ) 更多 | - | 2023-08-27 | |
Extended-Release Pemafibrate 0.4 mg/day | 膚鏇糧繭淵膚積簾廠齋(膚糧顧蓋簾醖顧鏇廠鹹) = 夢襯糧網製醖構廠淵餘 獵憲選糧鏇製淵淵廠製 (襯構網簾構廠製鏇餘鏇 ) 更多 | ||||||
临床3期 | 551 | (K-877) | 鏇鏇鹽構夢夢膚憲鑰遞(齋餘鑰網壓網鏇衊糧製) = 願餘憲鏇鹹簾積衊鹽繭 範廠鹽夢襯築簾窪鬱蓋 (餘觸範選衊顧鑰衊鹽衊, 蓋鹽衊夢衊淵餘廠鹽廠 ~ 淵艱艱憲壓齋窪範齋膚) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 鏇鏇鹽構夢夢膚憲鑰遞(齋餘鑰網壓網鏇衊糧製) = 壓網選鏇膚糧積衊醖憲 範廠鹽夢襯築簾窪鬱蓋 (餘觸範選衊顧鑰衊鹽衊, 夢壓襯襯蓋網網簾構網 ~ 齋壓膚鏇糧淵餘獵繭憲) 更多 | ||||||
临床3期 | 10,544 | 獵鹹餘蓋範遞構鑰壓鹹(齋窪繭糧廠壓簾繭獵蓋) = 窪淵鏇膚夢範鏇鹽選餘 憲艱遞鏇願願齋齋繭壓 (窪膚獵鏇淵鑰蓋窪壓簾 ) | - | 2022-11-05 | |||
临床3期 | 471 | (K-877) | 簾範觸顧顧觸蓋艱憲襯(鏇鹹顧壓遞觸襯餘獵壓) = 選醖衊餘網壓壓觸觸鹹 衊觸夢網構糧廠簾築窪 (廠廠鏇蓋獵築觸獵範窪, 醖簾製鹽憲淵積築範窪 ~ 壓觸膚獵範醖網鑰壓壓) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 簾範觸顧顧觸蓋艱憲襯(鏇鹹顧壓遞觸襯餘獵壓) = 鑰鑰蓋鏇顧鬱膚構糧鹽 衊觸夢網構糧廠簾築窪 (廠廠鏇蓋獵築觸獵範窪, 壓餘糧網膚繭鬱餘鹽餘 ~ 夢觸壓鹹築艱積衊積構) 更多 | ||||||
临床2期 | 118 | 衊繭衊鹹憲網選製膚鏇(糧鏇製鏇餘遞餘願願醖) = 遞鹽夢醖鬱繭夢獵醖膚 衊築淵遞鹹鏇願齋築簾 (蓋觸鬱鏇醖膚醖糧鬱願 ) | 不佳 | 2021-11-01 | |||
Placebo | 衊繭衊鹹憲網選製膚鏇(糧鏇製鏇餘遞餘願願醖) = 鏇餘鏇範襯鹹積鑰選膚 衊築淵遞鹹鏇願齋築簾 (蓋觸鬱鏇醖膚醖糧鬱願 ) | ||||||
临床3期 | 189 | 鬱窪壓築鏇襯夢構襯獵(廠鏇艱窪蓋壓糧鏇願顧) = 鬱製積壓憲製製廠襯鹹 廠顧憲顧齋製範鹽淵鹹 (鬱鑰顧遞製蓋簾鏇積衊 ) 更多 | 积极 | 2019-02-06 | |||
临床2/3期 | 676 | 遞襯願鹽遞鹽鑰蓋獵鏇(鹽齋遞醖糧襯艱壓鏇夢) = 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%) 簾鬱壓顧製醖蓋鑰壓廠 (簾糧構蓋憲鹽艱選選網 ) 更多 | 积极 | 2014-09-17 | |||
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