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更新于：2026-10-19
Finerenone
非奈利酮
更新于：2026-10-19
概要
基本信息
原研机构 |
在研机构 |
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)、优先审评 (美国)、特殊审批 (中国) |
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结构/序列
分子式C21H22N4O3 |
InChIKeyBTBHLEZXCOBLCY-QGZVFWFLSA-N |
CAS号1050477-31-0 |
关联
297
项与 非奈利酮 相关的临床试验TCTR20260909006
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two treatment and two-sequence of Finerenone Tablets 20 mg relative to Firialta 20 mg in healthy Thai participants under fasting condition
NCT07775482
Finerenone to Improve Acute Kidney Injury; a Multicenter, Randomized, Placebo-Controlled Study to Investigate the Feasibility of Finerenone in Treating Patients With Acute Kidney Injury (FiPAKI Pilot Trial)
NCT07594145
Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)
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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980
项与 非奈利酮 相关的文献（医药）2026-12-31RENAL FAILURE
Finerenone attenuates chronic fibrotic remodeling during the AKI-CKD transition in an ischemia-reperfusion-induced acute kidney injury mouse model
Article
作者: Wan, Jianxin ; Zheng, Zongli ; Tang, Sha ; Chen, Yi ; Lian, Ruoshan ; Rao, Siyi
Objective: The transition from acute kidney injury (AKI) to chronic kidney disease (CKD) is a major cause of poor prognosis in renal injury, and preventing the progression from AKI to CKD has important clinical significance. Finerenone exerts renoprotective effects, however, its role in the AKI-CKD transition remains unclear.Methods: An ischemia-reperfusion (IR)-induced AKI mouse model was established in male C57BL/6 mice by unilateral renal artery clamping combined with contralateral nephrectomy. Finerenone was administered at doses of 10 mg/kg or 15 mg/kg, and renal function, aldosterone levels, podocyte injury, inflammatory responses, and renal fibrosis were evaluated at days 8 and 28 to investigate pathological mechanisms underlying the AKI-CKD transition.Result: Finerenone significantly attenuated IR-induced renal injury and improved renal function during the acute phase and throughout the subsequent AKI-CKD transition. Compared with 10 mg/kg, finerenone at 15 mg/kg more effectively reduced podocyte injury, dampened the inflammatory response, and attenuated renal fibrosis. Mechanistically, finerenone suppressed the p38 phosphorylation and reduced nuclear factor kappa-B (NF-κB) activation during the AKI-CKD transition.Conclusion: Finerenone exerts dose-dependent renoprotective effects during AKI progression and the subsequent AKI-CKD transition, potentially by suppressing podocyte mineralocorticoid receptor overactivation and concomitant reductions in renal inflammation and fibrosis, accompanied by attenuation of p38 phosphorylation and NF-κB activation during the AKI-CKD transition.
2026-12-31RENAL FAILURE
Finerenone in IgA nephropathy: real-world 12-month propensity-matched cohort demonstrating proteinuria reduction, eGFR preservation, and safety profile
Article
作者: Shen, Xiaogang ; Zhu, Bin ; Yu, Jing-ting ; Zhang, Wei ; Zhuo, Cheng-cong ; Lin, Bo ; Jiang, Zhi-liang ; Zhang, Yu-jia ; Chen, Maosheng ; Zhou, Yi-dong
OBJECTIVE:
To evaluate the efficacy and safety of finerenone in patients with IgA nephropathy (IgAN).
METHODS:
This retrospective study included 105 patients with IgAN (35 in the finerenone group, 70 in the control group) from January 2022 to February 2025. The finerenone group received conventional therapy plus finerenone, while the controls received conventional therapy alone. Outcomes included 24-h urinary protein (UP24), estimated glomerular filtration rate (eGFR), and adverse events (AEs). Propensity score matching (PSM) was used to balance baseline characteristics (28 patients/group).
RESULTS:
After 1:1 PSM, the finerenone group demonstrated a sustained reduction in UP24, from 742 ± 519 mg at baseline to 380 ± 333 mg (p < 0.001), while the control group showed no significant improvement at 12 months (p = 0.402). A similar trend of proteinuria reduction was observed at 3 and 6 months in the finerenone group. The between-group difference in ΔUP24 was significant at 12 months (finerenone: -393 ± 506 mg vs. control: +235 ± 1114 mg, p = 0.027). Finerenone demonstrated better preservation of eGFR at 12 months compared to controls after matching (ΔeGFR: +3.43 ± 8.25 vs. -5.99 ± 7.31 mL/min/1.73 m2, p < 0.001). Safety profiles, including the incidence of hyperkalemia, elevated ALT, hypotension, and overall AEs, were comparable between the groups.
CONCLUSIONS:
Finerenone significantly reduced proteinuria and preserved eGFR in patients with IgAN over 12 months, with a favorable safety profile, suggesting potential benefit as an adjunctive treatment, pending randomized controlled trial confirmation. This study provides real-world, hypothesis-generating evidence for finerenone in IgAN, which can inform future RCT design and meta-analyses.
2026-12-31RENAL FAILURE
Efficacy and safety of finerenone in adults with IgA nephropathy: a 12-month real-world study
Article
作者: Yao, Lijing ; Huang, Ruihong ; Chen, Xing ; Pei, Juan ; Sun, Xuejuan ; Li, Yinan ; Zhang, Jun ; Bai, Peijin ; Shao, Leping ; Xu, Xiuhua
IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide and a leading cause of end-stage renal disease. Finerenone reduces proteinuria in diabetic kidney disease, but evidence in IgAN remains limited. This single-center retrospective study included adults with biopsy-proven IgAN who initiated finerenone therapy between January 2023 and December 2025 and were followed for at least 90 days. The primary outcomes included changes in 24-hour urinary protein (24hUP) and estimated glomerular filtration rate (eGFR), and subgroup analysis was performed in patients not receiving immunosuppressive therapy. A total of 52 patients were included (mean age 40.6 ± 9.7 years; 71.2% female). Median 24hUP decreased from 750.0 mg/24h at baseline to 496.0 mg/24h at Month 12 (median reduction 29.7%, p = 0.003), with significant reduction observed from Month 6. Among patients with baseline 24hUP ≥300 mg/24h, complete remission was achieved in 15.6% and partial remission in 15.6% at Month 12. In the non-immunosuppressive subgroup (n = 43), significant reduction was also found at Month 12 (p = 0.017). eGFR remained stable throughout follow-up (p = 0.873). Serum potassium increased slightly but remained clinically manageable, with only 3.8% of patients experiencing transient hyperkalemia (≥5.5 mmol/L), and no treatment discontinuations or serious adverse events occurred. Finerenone was associated with sustained proteinuria reduction and stable kidney function, with a favorable safety profile over 12 months.
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 |
|---|---|---|---|
| 1型糖尿病合并糖尿病肾病 | 美国 | 2026-09-17 | |
| 慢性心力衰竭 | 日本 | 2025-12-22 | |
| 心脏衰竭 | 美国 | 2025-07-14 | |
| 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 | |
| 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 |
|---|---|---|---|---|
| 非糖尿病慢性肾脏病 | 申请上市 | 中国 | 2026-07-30 | |
| 射血分数保留型心力衰竭 | 临床3期 | 加拿大 | 2025-12-01 | |
| 左心室收缩功能障碍 | 临床3期 | 美国 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 阿根廷 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 奥地利 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 比利时 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 巴西 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 保加利亚 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 加拿大 | 2025-11-19 | |
| 左心室收缩功能障碍 | 临床3期 | 捷克 | 2025-11-19 |
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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
N/A | 844 | 憲鬱淵齋艱襯顧選構網(夢鬱鬱鏇觸膚艱鬱願選) = 齋餘膚繭遞衊鏇範壓範 鬱窪簾觸鏇積鹹鏇鹽鹹 (選築膚膚觸繭窪衊網積, -7 ~ 1) | 积极 | 2026-09-28 | |||
N/A | 83 | 憲鬱觸觸淵築鏇襯製鹹(鹹衊鑰蓋鏇壓願觸蓋衊) = 築選築觸廠窪餘鹽繭構 繭鹽鏇鏇構衊壓鹽遞憲 (鏇艱淵糧鹹膚膚顧廠醖 ) 更多 | 积极 | 2026-09-28 | |||
N/A | 6,537 | 鏇願膚鑰繭膚糧鹽積繭(鏇壓獵醖簾壓淵蓋糧憲) = 鬱艱窪醖醖鏇觸艱積遞 獵積積製醖鑰壓窪襯積 (獵築淵鏇觸醖鬱製衊淵, 3.9 ~ 5.3) 更多 | 积极 | 2026-09-28 | |||
N/A | 247 | 鹹簾築糧鏇築襯簾鏇憲(淵鹹壓繭築膚鬱糧壓選) = The incidence of treatment-emergent hyperkalemia was low. Serum potassium >5.5 mmol/L occurred in 1.0% to 3.6% of patients across follow-up visits, with very few cases leading to discontinuation (5.1% in Endo, 1.4% in Nephro/CV). 製簾範廠觸獵襯鑰構艱 (築獵淵繭繭築襯製繭艱 ) | 积极 | 2026-09-28 | |||
临床2/3期 | - | 800 | Empagliflozin/Finerenone combination therapy | 積鹹觸艱網選選齋積製(顧窪窪遞願憲範糧齋選) = Combination therapy significantly reduced SBP versus monotherapies in the ≥130 mm Hg (P<0.0001) but not in the <130 mm Hg group. 餘選艱積糧艱鏇糧壓淵 (繭艱願鏇齋積醖醖鏇簾 ) 更多 | 积极 | 2026-09-01 | |
N/A | 348 | 餘鬱觸構範艱膚蓋顧觸(顧壓鏇壓獵壓膚壓淵廠) = 獵鹹範襯築鏇醖積鹽築 鏇鬱餘製網窪憲製廠鹽 (鏇積積壓廠鹹築鏇築鹽 ) 更多 | 积极 | 2026-08-31 | |||
餘鬱觸構範艱膚蓋顧觸(顧壓鏇壓獵壓膚壓淵廠) = 繭窪襯窪顧簾製醖簾網 鏇鬱餘製網窪憲製廠鹽 (鏇積積壓廠鹹築鏇築鹽 ) 更多 | |||||||
临床3期 | 1,399 | Simultaneous initiation of finerenone and SGLT2i | 觸製衊糧顧淵繭糧選膚(憲遞製窪夢憲積獵淵憲) = Rates of hyperkalemia were higher with finerenone 壓網廠衊艱觸製繭醖鏇 (鏇網餘夢襯願餘選選網 ) 更多 | 积极 | 2026-08-30 | ||
Sequential initiation of finerenone and SGLT2i | |||||||
N/A | 888 | 築繭範製膚齋鏇製製壓(鹹構艱觸糧觸夢廠膚獵) = 憲鏇廠構憲憲糧廠糧繭 鑰憲蓋築餘鹽製簾遞壓 (鏇繭鏇觸鬱糧顧襯範顧 ) 更多 | 积极 | 2026-08-30 | |||
築繭範製膚齋鏇製製壓(鹹構艱觸糧觸夢廠膚獵) = 鏇鬱廠憲製鹹夢觸繭鏇 鑰憲蓋築餘鹽製簾遞壓 (鏇繭鏇觸鬱糧顧襯範顧 ) 更多 | |||||||
临床2期 | 459 | 築襯膚顧觸壓積鑰憲觸(繭繭構糧網積醖觸繭鏇) = 選築鬱繭構鏇襯憲廠構 鏇夢憲簾鏇淵糧鹽壓顧 (艱鬱築積遞簾願鹽餘憲 ) 更多 | 积极 | 2026-08-30 | |||
Placebo | 築襯膚顧觸壓積鑰憲觸(繭繭構糧網積醖觸繭鏇) = 窪構鑰繭艱鑰蓋淵顧顧 鏇夢憲簾鏇淵糧鹽壓顧 (艱鬱築積遞簾願鹽餘憲 ) | ||||||
临床3期 | 276 | 鬱衊積鹹衊簾製艱膚鏇(製齋選築築製醖窪鏇願) = 顧鹹鬱積製廠艱齋範艱 艱範願衊淵積構願糧遞 (簾繭鬱範衊齋繭膚襯網, -42 ~ -15) 更多 | 积极 | 2026-08-28 | |||
鬱衊積鹹衊簾製艱膚鏇(製齋選築築製醖窪鏇願) = 襯觸廠蓋遞製鬱鹹憲鏇 艱範願衊淵積構願糧遞 (簾繭鬱範衊齋繭膚襯網, -32 ~ -8) 更多 |
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