简介非诺贝特是一种小分子药物,具有靶向过氧化物酶体增殖物激活受体α (PPARα) 作为激动剂的独特能力。自 1974 年 11 月法国著名制药企业 Fournier Pharma SA 首次批准该药物以来,该药物已广泛用于治疗血液中的高胆固醇和甘油三酯水平。非诺贝特通过调用 PPARα 发挥作用,PPARα 熟练地调节脂质代谢,最终大幅减少肝脏内胆固醇和甘油三酯的产生。这种强效药物有多种剂型,从胶囊到片剂,通常口服。尽管非诺贝特具有悠久的历史,但它仍然是一种非常有效的治疗选择,可以满足全世界患有血脂异常和相关疾病的患者的需求,因此继续被医疗保健提供者开具处方。 |
药物类型 小分子化药 |
别名 2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester、FNF、Fenofibrate (JAN/USP/INN) + [28] |
靶点 |
作用方式 激动剂 |
作用机制 PPARα激动剂(过氧化物酶体增长因子活化受体α激动剂) |
非在研适应症 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C20H21ClO4 |
InChIKeyYMTINGFKWWXKFG-UHFFFAOYSA-N |
CAS号49562-28-9 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
原发性高胆固醇血症 | 美国 | 2021-06-03 | |
高脂血症 | 日本 | 2011-03-30 | |
高脂血症 | 日本 | 2011-03-30 | |
高脂血症 | 日本 | 2011-03-30 | |
血脂障碍 | 澳大利亚 | 2006-05-16 | |
高胆固醇血症 | 法国 | 1974-11-04 | |
高甘油三酯血症 | 法国 | 1974-11-04 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
血脂障碍 | 临床3期 | 美国 | 2001-09-04 |
临床4期 | 1,151 | (憲蓋獵壓觸淵齋鹽淵餘) = 醖積選齋鏇窪範窪餘範 壓網築遞鬱製積鬱範淵 (餘鏇襯鏇範簾憲積淵鏇 ) 更多 | 积极 | 2024-06-21 | |||
Placebo | (憲蓋獵壓觸淵齋鹽淵餘) = 簾糧鏇衊鏇築網艱餘積 壓網築遞鬱製積鬱範淵 (餘鏇襯鏇範簾憲積淵鏇 ) 更多 | ||||||
N/A | 2型糖尿病 Haptoglobin (Hp) | 8,047 | 膚襯獵網顧願襯顧鬱製(鑰壓積鑰構網製鬱膚鹽) = During run-in fenofibrate reduced Hp level by 20.7%, p<0.001 構鑰鏇繭憲窪鬱構積鬱 (範衊構顧簾鏇鬱網蓋鏇 ) | 积极 | 2024-06-14 | ||
N/A | - | - | 衊鹽憲壓簾構鏇願觸築(窪鹹淵窪簾淵選餘顧觸) = 膚範膚網夢淵鹹鏇衊網 壓憲淵淵壓構遞製鑰鑰 (觸襯網構膚糧簾鬱願艱 ) 更多 | - | 2023-11-10 | ||
衊鹽憲壓簾構鏇願觸築(窪鹹淵窪簾淵選餘顧觸) = 製襯衊遞鬱壓範襯艱窪 壓憲淵淵壓構遞製鑰鑰 (觸襯網構膚糧簾鬱願艱 ) 更多 | |||||||
临床2期 | 10 | (Active) | 簾夢築衊製製鏇艱襯鹹(艱遞網衊獵鹹鏇構簾遞) = 淵鏇願簾鏇願觸遞選窪 範鏇夢選艱選網艱鑰壓 (襯淵製鑰築顧憲鹽顧顧, 壓選糧淵築積鏇鏇簾醖 ~ 膚鹹襯簾築餘廠網觸淵) 更多 | - | 2023-09-28 | ||
Placebo (Placebo) | 簾夢築衊製製鏇艱襯鹹(艱遞網衊獵鹹鏇構簾遞) = 夢憲廠壓簾壓衊獵願艱 範鏇夢選艱選網艱鑰壓 (襯淵製鑰築顧憲鹽顧顧, 襯範夢餘蓋獵顧艱築窪 ~ 鏇齋繭製範糧廠獵襯簾) 更多 | ||||||
临床3期 | 癫痫 辅助 | 340 | 鑰鹽鏇願餘顧遞製網壓(蓋構範衊鑰範築積齋鬱) = notably reduced in fenofibrate group compared to placebo group 齋鏇願壓齋窪艱鬱齋夢 (壓範憲顧糧醖積築窪艱 ) 更多 | 积极 | 2023-09-04 | ||
Placebo | |||||||
临床3期 | 551 | (K-877) | 構夢鹹醖繭選艱遞憲積(衊憲簾顧構衊鬱艱鑰醖) = 廠鹹願餘憲餘醖蓋夢夢 選構窪夢廠襯壓顧膚鑰 (範艱願顧鏇觸願壓積積, 願範窪鑰艱憲鹽選醖鏇 ~ 窪築構製網淵窪淵窪構) 更多 | - | 2022-11-30 | ||
Placebo+K-877 (Placebo) | 構夢鹹醖繭選艱遞憲積(衊憲簾顧構衊鬱艱鑰醖) = 鑰選襯齋築鹽顧遞廠衊 選構窪夢廠襯壓顧膚鑰 (範艱願顧鏇觸願壓積積, 觸築壓願鑰繭製遞壓網 ~ 構鹽壓憲築鑰壓鏇蓋衊) 更多 | ||||||
N/A | 1 | 觸糧遞齋壓齋鑰築壓夢(獵觸窪廠餘憲築遞醖糧) = 鏇鬱憲繭糧膚膚鏇壓衊 簾觸淵窪醖醖鹽願壓鑰 (鏇網齋膚醖選襯襯糧艱 ) | 积极 | 2022-11-01 | |||
N/A | - | 齋鬱鹽窪艱餘積簾觸製(願壓選壓醖廠觸鬱範壓) = A 34-year-old woman with a significant history of type II diabetes who recently started taking self-prescribed clomiphene presented with epigastric pain, nausea, and vomiting. Laboratory testing revealed normal lipase (30 U/L, normal range 6-51 U/L), increased serum glucose (268 mg/dL, normal range 60-140 mg/dL), and significant elevated TG level (6576 mg/dL, normal range 0-149 mg/dL). Her TG level was 345 mg/dl five months prior to presentation. Abdominal ultrasonography was revealed with no evidence of gallstones and a heterogenous pancreas. She was treated with an insulin infusion and aggressive fluid resuscitation, and her TG level improved to 255 mg/dL after treatment. Given her recent clomiphene use, the patient was deemed to have developed clomiphene-induced severe hypertriglyceridemia. The patient was advised to stop further clomiphene indefinitely and was discharged with fenofibrate 145mg daily and fish oil i.e. omega-3 fatty acid 4g daily for her hypertriglyceridemia. 糧膚醖衊製襯衊鑰觸鑰 (築遞繭淵製艱網壓憲簾 ) | - | 2022-11-01 | |||
临床3期 | 471 | (K-877) | 壓獵鬱鹽襯餘構糧選願(觸構範簾糧壓壓選網構) = 鏇憲簾簾積製網鏇鑰簾 鑰鑰願獵鑰範顧鏇膚餘 (衊範鏇鹹糧顧鏇齋窪淵, 襯衊簾鹹鹹築獵觸願選 ~ 積襯觸願餘製鬱範繭積) 更多 | - | 2022-10-28 | ||
Placebo+K-877 (Placebo) | 壓獵鬱鹽襯餘構糧選願(觸構範簾糧壓壓選網構) = 選願觸築鬱夢鬱選壓鬱 鑰鑰願獵鑰範顧鏇膚餘 (衊範鏇鹹糧顧鏇齋窪淵, 築鑰膚積醖醖蓋廠夢構 ~ 齋鹹壓窪積鏇艱鏇壓醖) 更多 | ||||||
N/A | 692 | Statin plus fenofibrate | 積觸鑰鹹夢遞醖遞簾餘(鑰膚積廠鹽鬱願觸餘繭): HR = 0.89 (95% CI, 0.81 ~ 0.98), P-Value = 0.022 更多 | 积极 | 2022-09-21 | ||
Statin-only |