更新于：2024-12-24
Finerenone
非奈利酮
更新于：2024-12-24
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-07-09), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、特殊审批 (中国) |
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结构
分子式C21H22N4O3 |
InChIKeyBTBHLEZXCOBLCY-QGZVFWFLSA-N |
CAS号1050477-31-0 |
关联
88
项与 非奈利酮 相关的临床试验An study on the efficacy and safety of Finerenone in proteinuria patients after kidney transplantation
非奈利酮片在健康受试者中随机、开放、两制剂、单次给药、两周期、双交叉空腹和餐后状态下的生物等效性试验
Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i As Triple Therapy with Type 2 Diabetes and Chronic Kidney Disease
100 项与 非奈利酮 相关的临床结果
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100 项与 非奈利酮 相关的转化医学
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100 项与 非奈利酮 相关的专利（医药）
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420
项与 非奈利酮 相关的文献（医药）2025-01-01DIABETES OBESITY & METABOLISM
Prevalence of individuals with diabetes and chronic kidney disease indicated for finerenone treatment in the United States: A National Health and Nutrition Examination Survey‐based estimation
Letter
作者: Kong, Xiufang ; Wang, Wei
2024-12-31RENAL FAILURE
Effectiveness and safety of finerenone in diabetic kidney disease patients: a real-world observational study from China
Article
作者: Fang, Ming ; Zhou, Jingying ; Li, Xinwei ; Guo, Xianan ; Gu, Chenjie ; Kang, Le
AIMS:
Finerenone has been approved for treating diabetic kidney disease (DKD) with reducing cardiorenal risk. Real-world data on finerenone treatment for the management of DKD are presently lacking. This study aimed to investigate the effect of finerenone on the renal parameters of the Chinese DKD population in the real-world medical setting for the first time, especially in combination with renin-angiotensin system inhibitors (RASi) and sodium-glucose cotransporter 2 inhibitors (SGLT2i).
METHODS:
Forty-two DKD patients were selected and completed a 6-month finerenone treatment. Renal parameters and adverse effects were collected at every visit.
RESULTS:
The median urine albumin-to-creatinine ratio (UACR) was 1426.11 (755.42, 3638.23) mg/g. Among them, the proportion of patients with a UACR of 300-5000 mg/g was 76.2%, and the proportion of patients with a UACR of >5000 mg/g was 14.3%. The median estimated glomerular filtration rate (eGFR) was 54.50 (34.16, 81.73) mL/min/1.73 m2. Finerenone decreased the UACR significantly throughout the study period (p < .05). The maximal decline of UACR at month 6 was 73%. Moreover, the proportion of patients with a 30% or greater reduction in UACR was 68.42% in month 6. There was a smaller decline (9-11%) in the eGFR after initiating finerenone (p > .05). One patient each discontinued finerenone due to hyperkalemia (2.4%) and acute kidney injury (2.4%). No patient reported hypotension, breast pain, and gynecomastia.
CONCLUSIONS:
This study from China first demonstrated finerenone decreased UACR with manageable safety in real-world DKD treatment. A triple regimen of RASi, SGLT2i, and finerenone may be a promising treatment strategy for lowering albuminuria and reducing hyperkalemia risk in advanced DKD patients.
2024-12-01JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Finerenone, Obesity, and Heart Failure With Mildly Reduced/Preserved Ejection Fraction
Article
作者: Henderson, Alasdair D ; Zannad, Faiez ; Lam, Carolyn S P ; Vaduganathan, Muthiah ; Solomon, Scott D ; Claggett, Brian L ; Viswanathan, Prabhakar ; Verma, Subodh ; Kosiborod, Mikhail N ; McMurray, John J V ; Linssen, Gerard C M ; Schou, Morten ; Voors, Adriaan A ; Jhund, Pardeep S ; Lage, Andrea ; Pitt, Bertram ; Bauersachs, Johann ; Butt, Jawad H ; Shah, Sanjiv J ; Petrie, Mark C ; Senni, Michele ; Lay-Flurrie, James ; Fonseca, Cândida ; Scheerer, Markus F ; Desai, Akshay S
BACKGROUND:
Obesity is associated with excessive adipocyte-derived aldosterone secretion, independent of the classical renin-angiotensin-aldosterone cascade, and mineralocorticoid receptor antagonists may be more effective in patients with heart failure (HF) and obesity.
OBJECTIVES:
This study sought to examine the effects of the nonsteroidal mineralocorticoid receptor antagonist finerenone compared with placebo, according to body mass index (BMI) in FINEARTS-HF (FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure).
METHODS:
A total of 6,001 patients with HF with NYHA functional class II, III, and IV, a left ventricular ejection fraction of ≥40%, evidence of structural heart disease, and elevated natriuretic peptide levels were randomized to finerenone or placebo. BMI (kg/m2) was examined using World Health Organization categories, namely, underweight/normal weight (<25.0 kg/m2; n = 1,306); overweight (25.0-29.9 kg/m2; n = 1,990); obesity class I (30.0-34.9 kg/m2; n = 1,546); obesity class II (35.0-39.9 kg/m2; n = 751); and obesity class III (≥40 kg/m2; n = 395). The primary outcome was cardiovascular death and total worsening HF events.
RESULTS:
Data on baseline BMI were available for 5,988 patients (median: 29.2 kg/m2; Q1-Q3: 25.5-33.6 kg/m2). Compared with patients who were underweight/normal weight, those with obesity class II or III had a higher risk of the primary outcome (underweight/normal weight, reference; overweight, unadjusted rate ratio: 0.96 [95% CI: 0.81-1.15]; obesity class I: 1.04 [95% CI: 0.86-1.26]; obesity class II-III: 1.26 [95% CI: 1.03-1.54]). The effect of finerenone on the primary outcome did not vary by baseline BMI (underweight/normal weight, rate ratio: 0.80 [95% CI: 0.62-1.04]; overweight: 0.91 [95% CI: 0.72-1.15]; obesity class I: 0.92 [95% CI: 0.72-1.19]; obesity class II-III: 0.67 [95% CI: 0.50-0.89]; Pinteraction = 0.32). However, when BMI was examined as a continuous variable, the beneficial effect of finerenone seemed to be greater in those with a higher BMI (Pinteraction = 0.005). A similar pattern was observed for total worsening HF events. Consistent effects across baseline BMI were observed for cardiovascular and all-cause death and improvement in the Kansas City Cardiomyopathy Questionnaire scores.
CONCLUSIONS:
In patients with HF with mildly reduced/preserved ejection fraction, the beneficial effects of finerenone on clinical events and symptoms were consistent, irrespective of BMI at baseline, possibly with a greater effect on the primary outcome in patients with higher BMI. (FINEARTS-HF [FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure]; NCT04435626).
100 项与 非奈利酮 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 |
|---|---|---|---|
| 2型糖尿病 | 加拿大 | 2022-10-14 | |
| 慢性肾病 | 韩国 | 2022-05-10 | |
| 2型糖尿病肾脏病 | 美国 | 2021-07-09 |
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 |
|---|---|---|---|---|
| 心脏衰竭 | 申请上市 | 中国 | 2021-02-03 | |
| 1型糖尿病 | 临床3期 | 美国 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 中国 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 加拿大 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 丹麦 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 德国 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 意大利 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 韩国 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 西班牙 | 2024-02-26 | |
| 1型糖尿病 | 临床3期 | 英国 | 2024-02-26 |
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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3期 | 6,001 | 襯壓蓋遞衊淵醖蓋簾遞(蓋糧鏇艱襯積艱鏇壓廠) = The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex 窪築鏇糧襯獵蓋蓋廠鹹 (壓鏇鏇醖夢獵願蓋蓋鑰 ) | 积极 | 2024-11-17 | |||
临床4期 | 504 | 築廠遞壓鏇構鑰構鹹積(觸餘壓觸鹽獵鹹顧窪壓) = 築淵網夢蓋鹹艱夢膚鹹 顧窪憲醖齋鑰艱鑰繭齋 (壓鏇鏇選夢築蓋餘鏇糧 ) 更多 | 积极 | 2024-09-28 | |||
临床3期 | 6,001 | Finerenone 20 mg | 衊獵餘構願築遞選範鏇(淵廠鏇淵鏇淵廠顧餘壓) = 蓋網衊鏇鏇艱積膚構獵 餘鹹廠糧製範鬱鹹憲鏇 (網廠鹽選顧觸構範鹽獵, 11.9 ~ 15.2) 更多 | 积极 | 2024-09-27 | ||
Placebo | 衊獵餘構願築遞選範鏇(淵廠鏇淵鏇淵廠顧餘壓) = 製醖襯簾餘網鑰衊蓋鏇 餘鹹廠糧製範鬱鹹憲鏇 (網廠鹽選顧觸構範鹽獵, 6.8 ~ 11.3) 更多 | ||||||
N/A | - | 壓廠製選遞憲廠鏇鹹糧(膚積築憲壓鏇構廠鏇齋) = 網築製衊憲壓築遞膚夢 積餘鹹齋製鏇選製壓遞 (構醖壓窪壓鑰觸壓蓋獵 ) 更多 | 积极 | 2024-09-01 | |||
Placebo | 壓廠製選遞憲廠鏇鹹糧(膚積築憲壓鏇構廠鏇齋) = 鑰積構顧製憲壓餘製鏇 積餘鹹齋製鏇選製壓遞 (構醖壓窪壓鑰觸壓蓋獵 ) 更多 | ||||||
临床3期 | - | (LVEF ≥40%) | 鑰膚壓壓醖廠遞築簾積(廠糧顧蓋鬱襯簾夢遞鑰): RR = 0.84 (95% CI, 0.74 ~ 0.95), P-Value = 0.007 达到 更多 | 积极 | 2024-09-01 | ||
Placebo (LVEF ≥40%) | |||||||
临床3期 | - | 網糧網窪齋憲壓淵艱願(鑰鑰衊糧顧憲製衊齋憲) = increased risk 窪築淵夢鏇製餘襯鏇構 (鑰獵醖範製鏇襯繭遞夢 ) 更多 | 积极 | 2024-09-01 | |||
临床3期 | 6,016 | 窪艱觸觸鏇淵鏇網遞鹽(範遞廠淵築廠壓鬱願艱) = Top-line results showed that compared to placebo, Kerendia was associated with a significant and clinically meaningful reduction in the trial’s main goal. 選簾簾艱蓋膚齋憲願廠 (願夢襯夢鏇衊鏇選範夢 ) 达到 更多 | 积极 | 2024-08-05 | |||
Placebo | |||||||
N/A | - | 遞衊鬱顧選築糧醖選窪(鏇觸範廠構鏇簾廠淵鬱) = 餘鹹選鏇衊繭襯醖鹽廠 鹽蓋餘顧鬱選鏇構製獵 (餘獵艱襯齋網築鑰糧廠 ) 更多 | - | 2024-06-14 | |||
临床3期 | 84 | 鑰鏇襯繭鹹醖願壓積膚(餘簾鏇壓淵選衊製獵齋) = Hyperkalemia was seen in 2 patients in each arm and could be managed without much concern 壓淵觸簾構鏇窪鬱觸糧 (鏇壓獵蓋淵構積範製壓 ) | 积极 | 2024-06-14 | |||
Alternative antihypertensive regimen | |||||||
临床3期 | - | 範夢築鹹艱鏇蓋遞顧顧(製遞築蓋簾積簾鹹願遞) = low for finerenone (2.6%) and placebo (0.9%) 網齋膚膚齋鑰選範鹽獵 (餘憲艱網繭繭糧簾膚醖 ) 更多 | 积极 | 2024-04-01 | |||
Placebo |
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