Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

开始日期2025-08-01

申办/合作机构

Bayer AG

SLCTR/2025/012

/ Suspended临床3期IIT

COmbiNed eFfIcacy and safety of an eaRly, intensive MAnagement sTrategy with fInerenOne and SGLT2 iNhibitor in patients hospitalized with Heart Failure (CONFIRMATION-HF)

开始日期2025-07-09

申办/合作机构

CPC Clinical Research

CTR20251858

/ RecruitingN/A

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

主要目的：以陕西君可力医药科技有限公司研制的非奈利酮片为受试制剂，以Bayer AG持证的非奈利酮片（商品名：Kerendia）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。次要目的：评价中国健康受试者单次空腹/餐后口服非奈利酮片受试制剂和参比制剂后的安全性。

开始日期2025-06-09

申办/合作机构

陕西君可力医药科技有限公司

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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651

项与非奈利酮相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of finerenone therapy for patients with chronic kidney disease and type 2 diabetes in England & Wales: results of the FINE-CKD model

Article

作者: Folkerts, Kerstin ; Roy-Chaudhury, Prabir ; Mernagh, Paul ; Levy, Pierre ; Pochopień, Michał ; Drzewiecka, Aleksandra ; Cherney, David ; Sullivan, Sean D. ; Millier, Aurélie ; Morris, Stephen

OBJECTIVE:

Chronic kidney disease (CKD) is the leading cause of kidney failure, end-stage kidney disease (ESKD), and cardiovascular (CV) events in patients with type 2 diabetes (T2D). The FIDELIO-DKD trial demonstrated that finerenone lowered the risk of renal and CV events in patients with CKD and T2D, regardless of cardiovascular disease history. This study evaluated the cost-effectiveness of finerenone added to background treatment (finerenone + BT) versus background treatment (BT) alone in patients with CKD and T2D from the perspective of the National Health Service in England and Wales.

METHODS:

A lifetime Markov model assessed the indicated usage of finerenone for the treatment of stage 3 or 4 CKD with albuminuria associated with T2D in adults, as per the relevant marketing authorization. The model structure considered kidney disease progression and CV risk, with health states encompassing patients' kidney disease stage and CV event profiles, using patient-level data from the FIDELIO-DKD trial. Model outcomes were life years, quality-adjusted life years (QALYs), per-patient costs, incremental costs, and incremental cost-effectiveness ratio (ICER). Sensitivity and scenario analysis were performed, including an analysis exploring the impact of real-world data which suggests more frequent sodium-glucose co-transporter-2 (SGLT2) inhibitor use in the United Kingdom since FIDELIO-DKD.

RESULTS:

Patients receiving finerenone experienced kidney and CV benefits, including reduced rates of nonfatal CV events and CV deaths, translating to improvements in survival and quality-adjusted life years (QALYs) of 6.11 and 5.97 per patient for finerenone + BT versus BT, respectively. Total discounted per-patient costs were £48,940 for finerenone + BT and £47,716 for BT alone, resulting in an incremental cost-effectiveness ratio of £8,808 per QALY gained for finerenone + BT versus BT.

CONCLUSION:

Sensitivity and scenario analyses, including more frequent SGLT2 inhibitor use consistent with real-world data, indicate a robust ICER that remains within the bounds of what is typically considered cost-effective.

2025-12-31·RENAL FAILURE

Non-steroidal mineralocorticoid receptor antagonist finerenone inhibits peritoneal fibrosis induced by high-glucose dialysate via regulating enhancer of zeste homolog 2 (EZH2) expression

Article

作者: Zhang, Xinyu ; Shu, Jianqiang ; Sun, Zhikang ; Sun, Jingshu ; Wang, Qinglian ; Wang, Simeng ; Xu, Ying ; Chong, Nannan ; Chen, Dandan

Finerenone, a novel high-selective aldosterone receptor antagonist, exhibits powerful anti-inflammatory and antifibrotic effects in previous researches. The aim of our study was to investigate of it on peritoneal fibrosis. In our current research, we found that high glucose could induce epithelial mesothelial transformation (EMT) of peritoneal mesothelial cells (HPMCs). Under high glucose stimulation, the addition of finerenone could alleviate high glucose induced EMT and disordered cytoskeleton rearrangement in HPMCs. Moreover, finerenone decreased the expression of enhancer of zeste homolog 2 (EZH2). Results of rescue experiment showed that after overexpression of EZH2 in the presence of finerenone, the protective effect of finerenone on EMT, migration capacity and cytoskeleton rearrangement was counteracted by EZH2 overexpression. The above results have also been demonstrated in in vivo experiments. These findings imply that finerenone could alleviate EMT and peritoneal fibrosis via regulating EZH2. More studies are needed to validate it and explore further mechanism.

2025-09-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Therapeutic effects of finerenone and exenatide on diabetes-induced heart failure: A combined approach targeting inflammation and oxidative stress

Article

作者: Günek, Emirhan ; Koçak, Ayşe ; Aydın, Elif ; Kaymak, Güllü ; Gündüz, Meliha Koldemir

Cardiovascular complications, particularly diabetic cardiomyopathy and heart failure, are leading causes of morbidity and mortality in patients with diabetes mellitus. This study aimed to investigate the therapeutic potential of finerenone and exenatide, individually and in combination, in mitigating diabetes-induced cardiac injury. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, exhibits strong anti-fibrotic and anti-inflammatory properties in cardiovascular and renal diseases. Exenatide, a glucagon-like peptide-1 receptor agonist, is recognized for its glucose-lowering effects and additional cardioprotective actions, including antioxidant and anti-inflammatory activities. The combination of these agents was hypothesized to exert synergistic effects by targeting complementary pathological pathways involved in diabetic cardiomyopathy progression. Type 1 diabetes was induced in rats by a single high-dose streptozotocin injection. Animals were divided into five groups: control, STZ, STZ with finerenone, STZ with exenatide, and STZ with both finerenone and exenatide. Cardiac tissues and serum samples were analyzed for oxidative stress markers (TOS, TAS), inflammatory cytokines (IL-6, IL-1β, TNF-α), and myocardial injury biomarkers (cTnT, cTnI) through RT-qPCR and Western blotting. NRF2 pathway activation was also evaluated to assess antioxidant responses. STZ-induced diabetic rats showed significant increases in hyperglycemia, inflammation, oxidative stress, and myocardial injury. Treatment with either finerenone or exenatide alone improved several parameters; however, the combination therapy provided the most substantial cardioprotective effects, with marked reductions in oxidative stress and inflammation and enhanced NRF2 expression. These findings suggest that the combined administration of finerenone and exenatide offers superior protection against diabetes-induced cardiac injury compared to monotherapies, supporting a dual-targeted therapeutic approach for diabetic cardiomyopathy.

307

项与非奈利酮相关的新闻（医药）

2025-06-26

·PRNewswire

BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal Therapy SHANGHAI, June 25, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its highly selective endothelin receptor type A (ETA) antagonist SC0062 for the treatment of diabetic kidney disease (DKD) with albuminuria. This marks the second BTD for SC0062, following its initial designation for IgA nephropathy (IgAN) with proteinuria, which is conducting in Phase III, underscoring the compound's transformative potential across multiple chronic kidney disease (CKD) indications. The designation is supported by compelling data from the DKD cohort of the Phase 2 2-SUCCEED study, where SC0062 demonstrated: 1) Statistically and clinically significant albuminuria reduction at the 20 mg dose versus placebo. 2) Favorable safety profile with no increase in the risk of fluid retention observed in the SC0062 group. 3) Good safety both as monotherapy and in combination with standard-of-care therapies including SGLT2 inhibitors, RAAS inhibitors, GLP-1 receptor agonists, insulin, and Finerenone (MRA).Most participants in the trial received SGLT2 (sodium-glucose co-transporter-2) inhibitors and RAAS (renin-angiotensin-aldosterone system) inhibitors as background therapies, over 70% received GLP-1 (Glucagon-like peptide-1) receptor agonists and/or insulin, and approximately one-third were on Finerenone (a mineralocorticoid receptor antagonist, MRA). "With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges," said Dr. Ivy Wang, BioCity Co-founder and Executive President. "This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide." Clinical and Commercial Context The completed Phase 2 2-SUCCEED program met all efficacy and safety endpoints in both IgAN and DKD cohorts at 12- and 24-week timepoints. Full DKD results will be presented at an upcoming international congress. DKD, affecting ~20.9 million patients in China (2021), drives the nation's CKD epidemic. Without innovation, age-standardized incidence rates（ASIR）are projected to rise 25% by 2036. Current therapies provide limited protection against progression to end-stage renal disease (ESRD). As an ETA antagonist showing optimized effect for CKD, SC0062 represents a mechanistically distinct approach that: Modulates renal hemodynamics Reduces proteinuria/albuminuria Counters inflammation and fibrosis With its demonstrated clinical benefits and superior selectivity profile, SC0062 is positioned to potentially become a best-in-class renal therapeutic. BioCity remains committed to advancing this promising candidate through late-stage development for multiple kidney disease indications. About SC0062 SC0062 is a novel and unique ETA antagonist characterized by its high selectivity for ETA compared to the endothelin receptor B (ETB). Its strong selectivity for ETA suggests that it has greater potential than non-selective endothelin receptor antagonists for slowing the progression of CKD while avoiding the side effects associated with non-selective medications in the same class used to treat IgAN and DKD and other types of CKD. Preclinical studies showed that SC0062 significantly improved pathological scores in acute and chronic kidney disease models. Completed Phase 1 studies demonstrated good safety, tolerability, and pharmacokinetics, with no signs of fluid retention. SC0062 has completed enrollment in both cohorts (IgAN and DKD) of the Phase 2 2-SUCCEED study. The IgAN cohort has met primary and secondary endpoints, with results published in JASN. The DKD cohort has now also met its primary and secondary endpoints. SC0062 has now received BTD twice from the CDE – first for IgAN with proteinuria and now for DKD with albuminuria. BioCity is conducting initiate two Phase 3 trials: SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). SUCCESS-01 has been launched at Guangdong Provincial People's Hospital, led by Professor Xueqing Yu, President of the hospital and President of the Asia-Pacific Society of Nephrology. About BioCity Biopharma Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC). Currently, SC0062 a highly selective ETA antagonist owned by BioCity, is in development for CKD. A Phase 3 confirmatory trial for IgAN has been initiated in China and a Phase 3 multi-regional clinical trial (MRCT) is being planned. In addition, BioCity has five core novel oncology assets in clinical development, including first-in-class CDH3- and GPC3-targeting antibody drug conjugates (ADCs), WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3. For more information, please visit: LinkedIn: BioCity Biopharma Business & Investment Inquiries: [email protected] | [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床3期突破性疗法临床1期

2025-06-26

·Pharmaceutical Technology

BioCity’s SC0062 gains NMPA breakthrough therapy designation

The programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints. Credit: PanuShot/Shutterstock. The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted BioCity’s endothelin receptor type A (ET A ) antagonist, SC0062, a second breakthrough therapy designation (BTD). This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy’s potential for chronic kidney disease indications. The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo. The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone. BioCity co-founder and executive president Dr Ivy Wang stated: “With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges. “This dual BTD recognition validates SC0062’s potential to redefine treatment paradigms across renal diseases. We’re accelerating development to deliver this promising therapy to patients worldwide.” GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts. SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects. Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models. The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention. It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints. With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

临床结果临床2期突破性疗法

2025-06-24

·国际糖尿病idiabetes

T2D合并CKD获益证据扩展！非奈利酮新研究亮相ADA，潘琦教授深度解析 | ADA 2025

编者按作为新型非甾体类盐皮质激素受体拮抗剂（nsMRA），非奈利酮在糖尿病合并慢性肾脏病（CKD）领域的应用价值持续引发学界关注。今年美国糖尿病协会科学年会（ADA 2025）公布的CONFIDENCE研究亚组分析、肾脏标志物研究及FINE-ONE研究的基线特征3项研究，从不同维度进一步丰富了非奈利酮的研究数据，拓展了对该药物心肾保护作用及机制的认知，为糖尿病肾脏疾病（DKD）患者的临床决策提供了更精细化的证据支持。本刊特邀北京医院潘琦教授对这3项研究进行深入解读。CONFIDENCE研究亚组：对于基线不同血糖水平的T2D合并CKD患者，联合治疗均可显著降低UACR本月初正式发布的CONFIDENCE研究首次回答了心肾保护药物非奈利酮和钠-葡萄糖协调转运蛋白2抑制剂（SGLT2i）联合应用的疗效和安全性问题，为心肾获益药物的应用策略提供了里程碑式证据。该研究证实，对于T2D合并CKD患者，相较任一单药治疗，非奈利酮与恩格列净同步起始联合使用更能显著降低白蛋白尿水平，相关结果已发表于《新英格兰医学杂志》[1]。CONFIDENCE研究的血糖亚组分析[2]刚刚在ADA年会公布，旨在评估基线糖化血红蛋白（HbA1c）水平是否影响联合治疗效果。研究设计与背景CONFIDENCE研究中，CKD定义为估算肾小球滤过率（eGFR）30~90 ml/min/1.73 m2、尿白蛋白肌酐比值（UACR）≥100~<5000 mg/g、HbA1c<11%。受试者按1:1:1随机分配至非奈利酮（10 mg/d或20 mg/d）+安慰剂、恩格列净（10 mg/d）+安慰剂、非奈利酮（10 mg/d或20 mg/d）+恩格列净（10 mg/d）治疗组。本次亚组分析按基线HbA1c水平对患者进行四分位数分组，分析HbA1c较基线的变化，同时评估第180天UACR较基线的相对变化，旨在评估基线血糖水平对联合治疗疗效的影响。关键结果数据基线特征2022年6月~2024年8月，共有来自14个国家/地区818例患者被随机分组，其中800例纳入全分析集。基线平均eGFR 54.2 ml/min/1.73m2，中位UACR 579 mg/g，781例受试者的平均HbA1c为7.3%。按基线HbA1c水平对患者进行四分位数分组（Q1，≤6.4%；Q2，>6.4% ~ ≤7.1%；Q3，>7.1% ~ ≤7.9%；Q4，>7.9%），各组人数分别为212例、190例、188例和191例。HbA1c四分位数组间的基线特征基本均衡，部分指标存在差异，其中包括平均HbA1c、中位UACR、糖尿病视网膜病变患病率及胰岛素使用率（表1）。表1. 按HbA1c四分位数划分的基线人口统计学和临床特征HbA1c变化第180天时，各治疗组之间HbA1c较基线的变化无显著差异，恩格列净组HbA1c较非奈利酮组有下降趋势（图1）。同样地，在每个四分位数组内，各治疗组第180天时HbA1c较基线的变化虽然无统计学差异，但恩格列净组HbA1c较非奈利酮组有更低的趋势，且随基线血糖升高趋势更明显（图2）。图1. 第180天时，各治疗组之间HbA1c较基线的变化无显著差异图2. 每个四分位数组内，各治疗组第180天时HbA1c较基线的变化也无差异UACR变化联合治疗在所有HbA1c四分位数组中降低UACR的幅度均显著大于单药治疗（图3）。Q1组联合治疗较非奈利酮单药和恩格列净单药分别多降低29%（95%CI：-48% ~ -4%）和38%（95%CI：-54% ~ -15%）（图4）；Q3组联合治疗较单药分别多降低36%（95%CI：-54% ~ -10%）和34%（95%CI：-52% ~ -10%）。这种差异在各血糖分层中具有一致性，提示联合治疗的肾脏保护作用不依赖于血糖控制效果（图4）。图3. 第180天时HbA1c较基线的最小二乘均数变化图4. 根据HbA1c四分位数分组，联合治疗相较于任一单药治疗从基线至第180天的UACR百分比变化该亚组分析证实，非奈利酮与恩格列净联合治疗在不同基线HbA1c水平的T2D合并CKD患者中，均可显著降低UACR，且效果优于单药治疗，为T2D合并CKD患者的心肾保护提供了联合用药的进一步证据。无论基线血糖如何，联合治疗均可比单药治疗提供更多的心肾脏保护获益。肾脏标志物研究：非奈利酮在优化治疗基础上的额外肾脏保护效应研究设计与方法该研究[3]回顾性分析了60例T2D合并CKD（1~3期）患者，所有患者均接受SGLT2i（达格列净）、血管紧张素受体拮抗剂（ARB，缬沙坦或替米沙坦）治疗，血压控制在<130/80 mmHg至少1年，在此基础上加用非奈利酮并随访6个月。定期监测体重、体重指数（BMI）、血压、血脂、高敏C反应蛋白（hs-CRP）、N末端脑钠肽前体（NT-ProBNP）、eGFR（分别基于肌酐和胱抑素C）、血钾及UACR等指标，旨在评估非奈利酮在接受ARB和SGLT2i治疗的DKD（1~3 期）患者中对肾脏标志物的影响。主要研究结果基线数据患者平均年龄60.05±10.21岁，80%患者eGFR>60 ml/min/1.73m2，86.66%患者UACR在30~300 mg/g，平均HbA1c 7.16%±0.169%，基于肌酐的eGFR（eGFRCr） 88.96 ± 33.15 ml/min/1.73m2，基于胱抑素C的eGFR（eGFRCy） 65.2 ± 22.115 ml/min/1.73m2，血钾4.576 ± 0.45 mEq/L，UACR 170.76 ± 241.84 μg/mg，hs-CRP 1.35 ± 1.13 mg/L，NT-ProBNP 106.87 ± 100.68 pg/ml。基线平均用药剂量缬沙坦112±39.2 mg，替米沙坦87.43±43.37 mg，非奈利酮12.67±4.43 mg。ARB使用者占66.66%，血管紧张素受体脑啡肽酶抑制剂（ARNI）使用者占33.33%，钙通道阻滞剂（CCB）使用者占33.33%，β受体阻滞剂使用者占30%。治疗后变化6个月时，UACR较基线显著降低59.35%（自基线降至101.348±33.93 μg/mg，P<0.001），体重平均下降0.8 kg（P=0.025）。而血压（收缩压降低1.33±1.671 mmHg，P=1；舒张压降低1.9±1.34 mmHg，P=0.486）、HbA1c（变化0.038%±0.105%，P=1）、eGFRCr（降低0.713±2.22 ml/min/1.73m²，P=1）、eGFRCy（降低6.0±3.26 ml/min/1.73m2，P=0.063）、血钾（降低0.007±0.048 mEq/L，P=0.1）及NT-ProBNP（升高11.018±5.69 pg/ml，P=0.174）等指标的变化均无统计学意义。非奈利酮剂量在随访期间增至16.70±4.92 mg，ARB剂量略有调整，但整体用药方案保持稳定。研究结果显示，在已接受SGLT2i和ARB优化治疗且血压控制达标的T2D合并早期CKD患者中，加用非奈利酮可进一步显著降低UACR，对血糖、血压、eGFR、血钾指标无明显影响。这一结果提示，非奈利酮的肾脏保护作用可能独立于传统降压、降糖及SGLT2i的机制，为临床中已接受标准治疗但仍存在蛋白尿的患者提供了肾脏保护的新选择。值得注意的是，UACR是T2D合并CKD心肾获益的强预测因子，该研究中，在ARB和SGLT2i治疗基础上，UACR降幅仍达59.35%，凸显了非奈利酮在蛋白尿管理和心肾保护中的独特价值。FINE-ONE研究基线特征：非奈利酮在1型糖尿病合并CKD患者中的探索1型糖尿病（T1D）患者中约1/3合并CKD，超过半数会出现肾功能显著丧失，近1/4进展至肾衰竭，而目前针对T1D合并CKD的特异性治疗手段有限。FINE-ONE研究旨在评估非奈利酮在T1D合并CKD患者中的疗效与安全性[4]。研究设计与基线数据FINE-ONE是一项正在进行的全球Ⅲ期非奈利酮临床研究。研究纳入242例T1D合并CKD患者，要求UACR≥200~<5000 mg/g，eGFR≥25~<90 ml/min/1.73m2，HbA1c<10%，血清钾≤4.8 mmol/L，且正在稳定服用ACEI/ARB。患者按1:1随机分至非奈利酮组（10 mg或20 mg，每日一次）或安慰剂治疗组。主要疗效指标是6个月时UACR相对于基线的变化（治疗结束后停药随访1个月）。值得注意的是，药监部门批准研究采用UACR作为主要终点，认可UACR作为桥接标志物可将FIDELITY研究T2D合并CKD人群的证据转换（“translate”）到FINE-ONE人群。在研究纳入的242例患者中，大多数为男性（65%），平均年龄51.6岁；最常见地域来自欧洲（50%），其次为北美（34%）和亚洲（16%）；86%患者有高血压病史，基线平均血压135.2/77.5 mmHg，超过99%患者使用ACEI/ARB，36%患者使用利尿剂，27%使用β受体阻滞剂；大约1/4患者有心血管疾病史，74%使用他汀；基线平均糖尿病病程32年（表2）。研究排除了在T1D中推荐证据有限的SGLT2i和GLP-1RA使用者。平均eGFR 58.8±19.1 ml/min/1.73m2，48%患者eGFR≥60 ml/min/1.73m2伴蛋白尿；中位UACR 549（299~1191）mg/g，74%患者UACR≥300 mg/g；平均HbA1c 7.6%±1.1%；平均血钾4.6±0.4 mmol/L（图5）。表2. FINE-ONE基线人口统计学和临床特征图5. FINE-ONE基线实验室数据FINE-ONE研究是首个评估非奈利酮用于T1D合并CKD患者的Ⅲ期研究，其基线数据显示入组患者具有较高的肾脏事件风险和心血管共病率。该研究结果将填补非奈利酮在T1D领域的证据空白，若能证实其肾脏保护作用，将为这一缺乏有效治疗手段的患者群体提供新的治疗选择。目前研究仍在进行中，其最终结果值得期待。专家点评非奈利酮重塑糖尿病肾脏疾病管理格局潘琦教授北京医院非奈利酮作为新一代nsMRA，ADA今年新公布的3项研究从多维度探索，进一步证实了其在DKD领域的循证价值。不同血糖水平患者联合治疗的全新证据CONFIDENCE亚组分析证实，非奈利酮与恩格列净联合治疗在平均HbA1c 6.4%~>7.9%的T2D合并CKD患者中，降低UACR效果均优于单药治疗（如HbA1c>7.9%组联合治疗较单药治疗多降34%~36%）。这一发现证明了在不同血糖水平的T2D合并CKD患者中联合治疗的普适性，不同血糖水平患者均可从非奈利酮与SGLT2i联合治疗方案中获得额外心肾保护收益。优化治疗基础上的增量保护真实世界研究显示，T2D合并早期（1~3期）CKD患者，在ARB+SGLT2i治疗基础上，加用非奈利酮仍可使UACR进一步降低59.35%，且安全性良好，对血糖、血压、eGFR和血钾均无显著影响。该结果揭示了其与现有疗法的机制互补性，为早期DKD患者提供蛋白尿和心肾风险管理新手段，其UACR降幅远超传统方案预期，提示非奈利酮在疾病早期的干预价值。T1D领域的开拓性探索FINE-ONE研究作为首个针对T1D合并CKD的Ⅲ期临床研究，入组患者呈现高肾病事件风险（中位UACR 549 mg/g）和高心血管共病特征。若证实疗效，将打破该人群治疗手段有限的困境，成为首个代表nsMRA的T1D心肾保护药物。从独特机制到心肾保护ADA发布的新研究数据进一步印证非奈利酮独立于血糖、血压、靶向肾脏纤维化的核心优势。作为国内外指南推荐的心肾保护重要支柱治疗药物之一，非奈利酮不断积累新证据，推动早期多机制心肾保护药物治疗，促进糖尿病合并CKD领域的管理迭代，使更多患者尽早获益。专家简介潘琦教授北京医院内分泌科主任医学博士，主任医师，教授，博士研究生导师中华医学会骨质疏松与骨矿盐分会委员中华医学会糖尿病学分会糖尿病监测与治疗技术学组副组长中国老年保健研究会老年骨质疏松分会秘书长中华医学会老年医学分会内分泌学组副组长北京医学会糖尿病分会副主任委员“四大慢病”国家科技重大专项首席项目负责人主持国家省部级课题9项，参与多项国家重大攻关课题、国家自然科学基金等项目国内外核心期刊发表论文160余篇《Diabetes Care中文版》《中华医学杂志》《中华内科杂志》《中华老年医学杂志》《中华全科医学杂志》《中国医学前沿》《中国糖尿病杂志》《中国心血管病杂志》编委参考文献（上下滑动可查看）1. Agarwal R, et al. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Jun 5. doi: 10.1056/NEJMoa2410659.2. Rajiv Agarwal, et al. Simultaneous Initiation of Finerenone and Empagliflozin Across the Glycemic Spectrum in the CONFIDENCE Trial.2025 ADA.3. Vishal Gupta, et al. Evaluating the Effect of Finerenone on Renal Markers in Patients with Diabetic Nephropathy (Stage 1–3) Receiving Angiotensin Receptor Blockers and SGLT2i Therapy. 2025 ADA.4. Hiddo L. Heerspink, et al. Baseline Characteristics for FINE-ONE — A Randomized Phase III Trial Assessing Finerenone in People with T1D and CKD. 2025 ADA.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果AACR会议临床1期

100 项与非奈利酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10633	非奈利酮	-	DB16165

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	加拿大	Bayer, Inc.	2022-10-14
慢性肾病	韩国	Bayer AG	2022-05-10
2型糖尿病肾脏病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2021-07-09

未上市

10 条进展最快的记录,

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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	美国	Bayer AG	2025-01-10
1型糖尿病	临床3期	美国	Bayer AG	2024-02-26
1型糖尿病	临床3期	中国	Bayer AG	2024-02-26
1型糖尿病	临床3期	加拿大	Bayer AG	2024-02-26
1型糖尿病	临床3期	丹麦	Bayer AG	2024-02-26
1型糖尿病	临床3期	德国	Bayer AG	2024-02-26
1型糖尿病	临床3期	意大利	Bayer AG	2024-02-26
1型糖尿病	临床3期	韩国	Bayer AG	2024-02-26
1型糖尿病	临床3期	西班牙	Bayer AG	2024-02-26
1型糖尿病	临床3期	英国	Bayer AG	2024-02-26

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05254002 (CONFIDENCE, Pubmed \| Company_Website) 人工标引	临床2期	2型糖尿病 \| 慢性肾病	784	Finerenone + Empagliflozin	艱築積襯鏇膚製鑰襯願(遞願獵範廠鏇壓鏇糧廠) = 糧襯構廠蓋齋簾築蓋醖範遞遞繭夢鬱襯觸願膚 (憲襯壓膚鹽鏇憲壓蓋簾 )	积极	2025-06-05
				Finerenone + Placebo	艱築積襯鏇膚製鑰襯願(遞願獵範廠鏇壓鏇糧廠) = 鏇齋構糧壓製範選觸製範遞遞繭夢鬱襯觸願膚 (憲襯壓膚鹽鏇憲壓蓋簾 )
NCT04435626 (Pubmed \| JAMA Cardiol)	临床3期	射血分数降低的心力衰竭 left ventricular ejection fraction (LVEF)	6,001	Finerenone 20 mg	構遞鹽鹹繭衊齋範範壓(壓蓋築夢選鬱餘網願窪) = 艱襯膚鏇製遞範積糧膚齋鬱遞淵願遞壓襯獵鏇 (齋窪獵艱鏇積鹽壓鑰顧 ) 更多	积极	2025-05-21
NCT04435626 (FINEARTS-HF, Pubmed \| Eur J Heart Fail)	临床3期	射血分数保留型心力衰竭	6,001	Finerenone	遞選蓋鑰鏇鏇鑰鏇製蓋(願鏇選壓獵簾選艱糧壓) = 醖廠醖顧窪鹹壓獵淵積鑰遞憲鹽衊壓選簾餘選 (鏇夢窪鏇積製醖衊顧艱, 449 ~ 1946) 更多	积极	2025-05-16
				Placebo	願遞窪襯簾壓製鹽蓋範(選襯夢淵醖艱膚願夢積) = 選範膚願願鏇膚選衊糧積製襯艱構鹹淵觸窪襯 (夢鹽醖積窪齋鑰鹹蓋廠, 8.1 ~ 16.7)
NCT06460987 (Pubmed \| Clin Kidney J)	N/A	免疫球蛋白a肾病	178	RASI	繭獵憲願壓獵衊鹽醖鹹(鹹觸鹹壓衊窪鑰鑰衊衊) = 衊夢憲淵範夢蓋鑰獵齋齋鑰觸觸衊糧網網膚糧 (餘壓鹹繭糧願艱積繭蓋 ) 更多	积极	2025-05-01
				RASI + Finerenone	繭獵憲願壓獵衊鹽醖鹹(鹹觸鹹壓衊窪鑰鑰衊衊) = 廠鏇網觸壓構餘鬱餘醖齋鑰觸觸衊糧網網膚糧 (餘壓鹹繭糧願艱積繭蓋 ) 更多
NCT04435626 (FINEARTS-HF, Pubmed \| Eur J Heart Fail)	临床3期	脑卒中 \| 心脏衰竭	6,001	Finerenone	醖網顧鑰艱膚餘網夢願(鹽簾襯網範鹽遞膚鏇顧) = 製網壓糧鬱鹹憲繭壓網簾壓蓋獵衊廠願蓋繭憲 (構憲憲鏇鏇觸淵壓顧鹽 ) 更多	积极	2025-04-29
				Placebo	醖網顧鑰艱膚餘網夢願(鹽簾襯網範鹽遞膚鏇顧) = 鑰獵遞鏇構艱範鏇壓壓簾壓蓋獵衊廠願蓋繭憲 (構憲憲鏇鏇觸淵壓顧鹽 ) 更多
NCT02545049 (FIDELITY \| FIGARO-DKD, NEWS) 人工标引	N/A	2型糖尿病 \| 慢性肾病	-	非奈利酮	繭製淵積遞構遞願醖網(襯壓醖鏇鹹鏇齋選衊醖) = 蓋醖糧選築夢蓋獵簾蓋醖網鏇構醖壓選窪簾憲 (衊簾築醖遞遞積廠窪齋 ) 更多	积极	2025-04-15
				Placebo	齋構鏇衊憲鬱製選醖餘(醖願積鏇鑰願壓憲壓積) = 餘衊簾鹽獵艱膚築網製壓積顧鏇築蓋構襯獵衊 (繭網餘餘鹹簾積窪餘構 ) 更多
NCT04435626 (FINEARTS-HF, Pubmed \| JAMA Cardiol)	临床3期	心房颤动 AF \| paroxysmal AF \| persistent or permanent AF	5,984	Finerenone 20 mg	憲積繭觸網艱壓鏇願餘(憲範壓廠淵顧壓壓繭膚) = 襯簾構衊夢製遞構襯繭鬱鬱淵夢壓餘繭繭淵願 (築觸艱繭獵願憲齋選製 )	积极	2025-03-29
				Finerenone 40 mg	憲積繭觸網艱壓鏇願餘(憲範壓廠淵顧壓壓繭膚) = 範鏇夢獵顧繭構艱夢遞鬱鬱淵夢壓餘繭繭淵願 (築觸艱繭獵願憲齋選製 )
ChiCTR2400087169 (Pubmed) 人工标引	N/A	2型糖尿病 \| 慢性肾病	64	Finerenone	製鏇艱鑰選餘憲築襯願(壓餘淵製蓋觸網壓憲選) = 鏇遞製憲觸窪蓋廠範鏇觸糧顧壓網淵蓋鹹壓選 (蓋蓋鬱艱衊願繭餘憲壓 ) 更多	积极	2025-03-15
NCT05254002 (CONFIDENCE, Pubmed \| Nephrol Dial Transplant)	临床2期	2型糖尿病 \| 慢性肾病 eGFR \| UACR \| HbA1c ... 更多	818	Finerenone plus Empagliflozin	膚鏇餘鬱遞製鹹鏇獵網(獵鑰網遞齋窪網餘築範) = 蓋製膚觸顧醖鏇糧觸鑰醖淵衊觸艱齋蓋鬱顧糧 (獵淵遞鏇窪鏇願醖繭鹽, 292 ~ 1140) 更多	积极	2025-02-07
NCT02545049 (FIDELITY, Pubmed \| JACC Adv)	临床3期	贫血 \| 2型糖尿病 \| 慢性肾病 serum hemoglobin levels	-	Finerenone	構簾鬱夢壓願蓋餘選廠(築鬱選繭齋憲鹽餘糧窪) = Patients with anemia experienced higher incidence of treatment-emergent hyperkalemia vs those without 糧憲窪鑰製繭夢夢製構 (窪範憲淵壓築鏇糧選壓 ) 更多	积极	2025-02-01
				Placebo