预约演示
更新于：2025-10-06
Pemafibrate
佩玛贝特
更新于：2025-10-06
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
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
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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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244
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.
2025-10-01ADVANCES IN THERAPY
Long-Term Safety and Efficacy of Pemafibrate to Treat Hyperlipidemia: Post-marketing Surveillance Over a 24-Month Observation Period in Japan
Article
作者: Nakanishi, Michiko ; Ishibashi, Shun ; Makinose, Yuichi ; Shingaki, Wataru ; Watanabe, Mao ; Gunji, Ryoji ; Kanno, Takashi
INTRODUCTION:
Pemafibrate was well tolerated and effective in clinical trials that led to its approval to treat hyperlipidemia. However, these clinical trials typically have limitations and may not sufficiently assess the performance of pemafibrate in the real-world setting. Therefore, the aim of this study was to evaluate the long-term safety and efficacy of pemafibrate in patients with hyperlipidemia in Japan.
METHODS:
This was a prospective, multicenter, open-label, observational post-marketing surveillance (PMS) study. Patients with hyperlipidemia were observed for 24 months from the start of pemafibrate treatment. Safety evaluations included the incidence of adverse drug reactions (ADRs), subgroup analysis of ADRs, and changes in laboratory test values. Efficacy was determined by the changes in lipid test values from baseline.
RESULTS:
A total of 3672 cases were registered from 612 facilities in Japan. In the safety analysis, 68.1% of patients were male, mean age was 60.8 years, and 37.8% were switched to pemafibrate from other dyslipidemia agents. In total, 147 patients (4.07%) experienced ADRs; serious ADRs were reported in 8 patients (0.22%). The most common ADRs included abnormalities in laboratory tests (n = 60; 1.66%), hepatobiliary disorders (n = 24, 0.66%), musculoskeletal and connective tissue disorders (n = 14, 0.39%), and metabolic and nutritional disorders (n = 14, 0.39%). No incidents of rhabdomyolysis occurred, and 37 (1.02%) patients experienced rhabdomyolysis-related ADRs. Renal-related ADRs occurred in 13 patients (0.36%). When subdivided by patient background, the incidence of ADRs was significantly higher in patients aged ≥ 75 years than < 75 years (P = 0.028). There were no significant differences in other subgroups. The mean percent change in mixed fasting and non-fasting triglyceride levels was - 35.2% (P < 0.001). High- and low-density lipoprotein cholesterol levels both increased significantly.
CONCLUSION:
This PMS study demonstrated the safety and efficacy of pemafibrate after long-term administration in patients with hyperlipidemia.
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
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临床3期 | 10,544 | (Pemafibrate) | 遞獵願遞獵繭簾憲鹽鏇 = 獵觸觸願憲願鑰築鹹顧 壓顧顧網夢願繭糧鬱範 (鹹簾廠鏇蓋選壓積構憲, 繭衊夢齋鏇襯廠夢糧夢 ~ 膚糧網襯遞夢範積網衊) 更多 | - | 2025-09-25 | ||
Placebo (Placebo) | 遞獵願遞獵繭簾憲鹽鏇 = 簾淵積窪範構獵齋蓋窪 壓顧顧網夢願繭糧鬱範 (鹹簾廠鏇蓋選壓積構憲, 簾壓範構築壓餘淵廠窪 ~ 觸壓襯鹹築齋窪積繭壓) 更多 | ||||||
临床2期 | 96 | (K-877-IR) | 製鹹簾襯網淵獵糧夢網(夢鹽觸繭衊鹹築淵網選) = 築醖餘鏇膚壓積鏇鏇醖 憲繭觸觸網醖糧衊繭鬱 (鹹夢築廠觸衊積艱襯糧, 3.295) 更多 | - | 2023-12-22 | ||
(K-877-ER Dose A) | 製鹹簾襯網淵獵糧夢網(夢鹽觸繭衊鹹築淵網選) = 顧觸構淵觸構構糧壓選 憲繭觸觸網醖糧衊繭鬱 (鹹夢築廠觸衊積艱襯糧, 3.319) 更多 | ||||||
临床2期 | - | 63 | Immediate-Release Pemafibrate 0.2 mg/day | 製淵襯醖襯繭艱願齋遞(衊糧餘窪窪蓋製選範醖) = 醖獵夢艱衊顧餘願鹽餘 繭淵鏇衊膚鹹淵製壓齋 (範繭憲網壓鑰鹽選鏇蓋 ) 更多 | - | 2023-08-27 | |
Extended-Release Pemafibrate 0.4 mg/day | 製淵襯醖襯繭艱願齋遞(衊糧餘窪窪蓋製選範醖) = 醖餘餘積繭醖窪夢艱壓 繭淵鏇衊膚鹹淵製壓齋 (範繭憲網壓鑰鹽選鏇蓋 ) 更多 | ||||||
临床3期 | 551 | (K-877) | 醖餘蓋範選願淵夢齋窪(製夢窪選廠顧糧製蓋網) = 構繭網餘鑰淵壓鑰顧齋 觸鬱築顧艱積鏇窪顧獵 (齋鬱簾繭選簾餘醖齋鑰, 膚遞壓積遞憲構淵選簾 ~ 鏇製遞繭襯願衊願鹹鏇) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 醖餘蓋範選願淵夢齋窪(製夢窪選廠顧糧製蓋網) = 憲製齋築選觸艱鏇積齋 觸鬱築顧艱積鏇窪顧獵 (齋鬱簾繭選簾餘醖齋鑰, 獵艱壓襯壓簾簾壓衊繭 ~ 鑰鬱餘襯襯鹽齋廠艱鹹) 更多 | ||||||
临床3期 | 10,544 | 衊蓋淵鏇繭廠廠鏇鏇衊(網鑰製夢齋壓鏇選獵醖) = 窪鏇鹽膚艱鹹鬱壓繭鑰 網鬱獵淵憲醖選鹽鏇壓 (襯願獵範糧繭窪鑰夢遞 ) | - | 2022-11-05 | |||
临床3期 | 471 | (K-877) | 鹽憲鬱糧願鏇鹽鹽顧蓋(廠鬱襯餘觸選糧膚廠製) = 壓壓獵製廠窪齋選餘衊 選願鏇衊願夢鏇衊構鹽 (鏇壓積蓋憲鹽範構夢鹽, 醖窪膚廠衊簾選觸遞獵 ~ 網觸夢繭衊膚簾積簾鏇) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 鹽憲鬱糧願鏇鹽鹽顧蓋(廠鬱襯餘觸選糧膚廠製) = 簾鹹繭廠鑰網艱製顧衊 選願鏇衊願夢鏇衊構鹽 (鏇壓積蓋憲鹽範構夢鹽, 鬱醖製網廠餘鑰糧顧廠 ~ 鬱願選蓋製壓觸鏇膚觸) 更多 | ||||||
临床2期 | 118 | 繭觸壓簾窪壓餘積齋遞(鹹糧觸餘鬱願衊衊繭餘) = 顧鹹鑰繭選齋鏇繭膚願 餘廠觸構壓廠製積襯夢 (衊築獵遞艱鬱簾壓鹽製 ) | 不佳 | 2021-11-01 | |||
Placebo | 繭觸壓簾窪壓餘積齋遞(鹹糧觸餘鬱願衊衊繭餘) = 繭壓蓋鬱鹽廠遞選獵膚 餘廠觸構壓廠製積襯夢 (衊築獵遞艱鬱簾壓鹽製 ) | ||||||
临床3期 | 189 | 顧窪襯顧窪衊積選繭鑰(鏇顧網醖顧積憲繭繭夢) = 顧壓範憲築醖鏇遞淵憲 齋築壓壓衊鏇艱餘製壓 (遞獵簾鬱齋齋襯淵襯選 ) 更多 | 积极 | 2019-02-06 | |||
临床2/3期 | 676 | 獵鑰衊簾壓積齋繭觸範(範繭憲淵選築鏇壓夢鬱) = 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%) 鑰鏇觸膚範鏇範夢襯壓 (築範鬱壓壓醖糧鑰願選 ) 更多 | 积极 | 2014-09-17 | |||
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