The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.
The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.

开始日期2024-10-08

申办/合作机构

浙江大学

NCT06608212 / Not yet recruitingN/A

FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5

This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function.
The participants in this study are allowed to take finerenone as part of their regular care from their doctors.
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it:
* Heart attacks
* Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021.
Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

开始日期2024-10-01

申办/合作机构

Bayer AG

NCT06573411 / Not yet recruiting临床4期IIT

Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

This is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. Eighty-eight patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.

开始日期2024-09-30

申办/合作机构

中山大学附属第一医院

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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403

项与非奈利酮相关的文献（医药）

2024-12-31·RENAL 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.

2024-11-01·Current drug discovery technologies

Finerenone: A Novel Drug Discovery for the Treatment of Chronic Kidney Disease

Review

作者: Rana, Akshita ; Sahu, Jagdish K.

Background::

The most common cause of chronic kidney disease (CKD) is diabetic nephropathy (DN). Primarily mineralocorticoid receptor antagonists (MRAs) (spironolactone and eplerenone), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers were used for the treatment of CKD, but due to the high risk of hyperkalaemia, the combination was infrequently used. Currently after approval by FDA in 2021, finerenone was found to be effective in the treatment of CKD. Finerenone slowdowns the progression of diabetic nephropathy and lessens the cardiovascular morbidity in DN patients.

Objective::

The main objective of this review article is to provide a comprehensive and insightful overview of the role of finerenone by mainly focusing on its pharmacological properties, toxicity, uses, bioanalytical technique used for determination, and treatment options.

Materials and Method::

Finerenone works by inhibiting the action of the mineralocorticoid receptor. Finerenone is quickly absorbed from the digestive tract after oral treatment and achieves peak plasma concentrations in 1-2 hours.

Result::

Finerenone is actively metabolized through oxidation, epoxidation substitution, and direct hydroxylation. Elimination of finerenone is done through urine and feces. Determination of finerenone can be done through HPLC-MS and LSC.

Conclusion::

The present review covers the complete picture of ADME properties, bioanalytical techniques, clinical trials, toxicity, and possible avenues in this arena. Finerenone is effective compared to other mineralocorticoid receptor-like spironolactone and eplerenone, for the treatment of chronic kidney disease.

2024-09-23·EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

Pharmacokinetic and Pharmacodynamic Interaction of Finerenone with Diltiazem, Fluconazole, and Ritonavir in Rats.

Article

作者: Jung, Woojin ; Ngo, Lien Thi ; Kim, So-Hyeon ; Yang, Sung-Yoon ; Park, Seongwon ; Tran, Quyen Thi ; Chae, Jung-Woo ; Lee, Hyunjung ; Bui, Tham Thi ; Yun, Hwi-Yeol

BACKGROUND AND OBJECTIVES:

Finerenone, a novel selective non-steroidal mineralocorticoid receptor antagonist, has been indicated in chronic kidney disease associated with type 2 diabetes mellitus. Considering the potential complications of diabetes, finerenone can be co-administered with various drugs, including fluconazole, diltiazem, and ritonavir. Given that finerenone is a substrate of cytochrome P450 (CYP) 3A4, the concurrent administration of finerenone with CYP3A4 inhibitors (diltiazem or fluconazole or ritonavir) could potentially lead to drug interactions, which may cause adverse events such as hyperkalemia. No studies have investigated interactions between finerenone and diltiazem or fluconazole or ritonavir. Therefore, this study aims to investigate the pharmacokinetic interaction of finerenone with diltiazem or fluconazole or ritonavir and to evaluate the impact of fluconazole on the pharmacodynamics of finerenone.

METHODS:

The pharmacokinetic study included four rat groups (n = 8 rats/group), including a control group (finerenone alone) and test groups (finerenone pretreated with diltiazem or fluconazole or ritonavir) using both non-compartment analysis (NCA) and population pharmacokinetic (pop-PK) modeling. The pop-PK model was developed using non-linear mixed-effects modeling in NONMEM^® (version 7.5.0). In the pharmacodynamic study, serum potassium (K⁺) levels were measured to assess the effects of fluconazole on finerenone-induced hyperkalemia.

RESULTS:

The NCA results indicated that the area under the plasma concentration-time curve (AUC) of finerenone increased by 1.86- and 1.95-fold when coadministered with fluconazole and ritonavir, respectively. In contrast, diltiazem did not affect the pharmacokinetics of finerenone. The pharmacokinetic profiles of finerenone were best described by a one-compartment disposition with first-order elimination and dual first-order absorption kinetics. The pop-PK modeling results demonstrated that the apparent clearance of finerenone decreased by 50.3% and 49.2% owing to the effects of fluconazole and ritonavir, respectively. Additionally, the slow absorption rate, which represents the absorption in the distal intestinal tract of finerenone, increased by 55.7% due to the effect of ritonavir. Simultaneously, a pharmacodynamic study revealed that finerenone in the presence of fluconazole caused a significant increase in K⁺ levels compared with finerenone alone.

CONCLUSIONS:

Coadministration of finerenone with fluconazole or ritonavir increased finerenone exposure in rats. Additionally, the administration of finerenone in the presence of fluconazole resulted in elevated K⁺ levels in rats. Further clinical studies are required to validate these findings.

197

项与非奈利酮相关的新闻（医药）

2024-09-10

·药融云

8月143款新药获批临床！9款创新药获批上市，涉及信达生物、盛迪亚生物医药……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授。 8月全球在研新药与靶点月报内容亮点 8月国内新药获批临床情况共有143款新药获批临床较上个月增加了3款，其中包括59款化药，80款生物制品，4款中药。 8月数量最多的新药为抗肿瘤药和免疫机能调节药物，有110个消化系统与代谢药物获批数量也比较多，有20个全球获孤儿药/突破性/快速通道资格认定品种盘点 8月共有46款药物获孤儿药/突破性/快速通道资格认定品种。全球在研创新药积极/失败临床结果最新动态速递拜耳公布“first-in-class”疗法Kerendia 3期临床结果 YAldeyra Therapeutics公布reproxalap3期临床数据，治疗干眼症 Citius Pharmaceuticals公布CTCL疗法Lymphir的3期临床数据安进公司公布Lumakras与Vectibix构成的组合疗法的3期临床数据每月相关创新药最新政策速递、国内新药注册申报、全球获孤儿药/突破性/快速通道资格认定品种盘点、全球在研创新药积极/失败临床结果TOP20、全球创新药研发进展TOP20等，药融咨询团队基于真实可溯源的全球医药数据，将每月推出「全球在研新药月报」，以期帮助业内人士通盘把握每月全球范围内的新药开发情况，全面而深入的了解全球新药开发动态。 01 8月国内新药获批临床/上市情况根据药融云数据统计，2024年8月共有143款新药获批临床（共计224个受理号），较上个月增加了3款，其中包括59款化药，80款生物制品，4款中药。截图来源：药融咨询月报本月获批临床受理号数量最多的新药为抗肿瘤药和免疫机能调节药物，有110个，占比为49%，消化系统与代谢药物获批数量也比较多，有20个。获批剂型主要为片剂与注射剂，分别有78个，20个。截图来源：药融咨询月报在8月份，国内医药市场迎来了9款创新药物的获批上市，涉及信达生物；康龙化成（宁波）科技的福泽雷塞片，适应症为至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者；苏州盛迪亚生物医药的夫那奇珠单抗注射液，适合接受系统治疗或光疗的中重度斑块状银屑病的成人患者。还有更多药企均迎来新的进展。截图来源：药融咨询月报 02 全球获孤儿药/突破性/快速通道资格认定品种盘点 8月共有46款药物获孤儿药/突破性/快速通道资格认定。强生宣布，美国FDA批准其EGFR/MET双特异性抗体amivantamab联合第三代EGFR-TKI口服药物lazertinib用于一线治疗经美国FDA批准检测证实带有EGFR外显子19缺失或外显子21中L858R替代突变的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者。 8月本月全球孤儿药/突破性/快速通道资格认定品种（部分）一览表备注：完整数据识别文末二维码下载查看 03 全球在研创新药积极/失败临床结果TOP20 在8月全球创新药研发动态中，辉瑞公司宣布了正在进行的关键性3期临床试验 MONeT 的子研究 B 的安全性和免疫原性结果，结果显示在免疫功能低下的成年患者中，接种两剂 Abrysvo 疫苗具有良好的安全性和免疫原性。截图来源：药融云全球药物研发数据库此外，拜耳公司宣布其“first-in-class”疗法 Kerendia（finerenone）的 3期临床结果。Kerendia在治疗左心室射血分数（LVEF）≥40%的心力衰竭（HF）患者的 3 期临床试验 FINEARTS-HF 中达到主要终点，显著减少了心血管死亡和心力衰竭事件构成的复合指标。截图来源：药融云全球药物研发数据库 8月21日，礼来公布其重磅药物tirzepatide为期三年的 SURMOUNT-1 临床 3期研究的积极顶线结果。分析显示，每周注射一次 tirzepatide可使糖尿病前期的肥胖或超重成人进展为2型糖尿病的风险显著降低 94%。此外，tirzepatide可使患者在整个治疗期间持续减重。在治疗期结束时，接受15mg 剂量治疗的成人体重平均下降 22.9%。Tirzepatide是一款葡萄糖依赖性促胰岛素多肽（GIP）和胰高血糖素样肽-1（GLP-1）受体双重激动剂，可同时激活GLP-1受体和GIP受体介导的信号通路。GIP和 GLP-1是调控血糖的天然的肠促胰岛素激素。 04 全球创新药研发进展TOP20 在8月全球创新药研发进展TOP20榜单中，亮点纷呈。首先，恒瑞医药宣布夫那奇珠单抗注射液获得临床试验默示许可，拟开发治疗适合接受系统治疗或光疗的 6 至小于 18 岁儿童和青少年中重度斑块状银屑病患者。紧接着，海思科1类新药HSK44459片获得临床试验默示许可，拟开发治疗间质性肺疾病。根据海思科此前公告介绍，这是其自主研发的一个全新的治疗间质性肺疾病的药物，为一种高选择性的环核苷酸磷酸二酯酶 4B（PDE4B）抑制剂。截图来源：药融云全球药物研发数据库同日，博安生物也传来佳音，博安生物宣布美国 FDA 已同意其自主研发的度拉糖肽注射液（BA5101）在美开展临床试验。BA5101 为 Trulicity 的生物类似药，拟用于 2 型糖尿病患者的血糖控制。 2024年8月全球新药研发进展完整报告识别下方二维码获取完整《2024年8月全球在研新药与靶点月报》PDF版本报告在每月初定期发布，敬请期待 END 本文为原创文章，转载请留言获取授权更多详细月报内容获取方式后台回复“2月全球新药”，获取完整《2月全球在研新药与靶点月报》PDF版。后台回复“3月全球新药”，获取完整《3月全球在研新药与靶点月报》PDF版。后台回复“4月全球新药”，获取完整《4月全球在研新药与靶点月报》PDF版。后台回复“5月全球新药”，获取完整《5月全球在研新药与靶点月报》PDF版。联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，申请药融云企业版免费试用！

孤儿药上市批准临床3期突破性疗法免疫疗法

2024-09-05

·PRNewswire

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 27-30

WASHINGTON, Sept. 5, 2024 /PRNewswire/ -- The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 27-30, at the Georgia World Congress Center and the new Signia by Hilton Atlanta in Atlanta, GA. Late breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Continue Reading The HFSA Annual Scientific Meeting takes place September 27-30, 2024 in Atlanta, Georgia. Sunday, September 29 Plenary Session | 9:00 AM – 10:30 AM STEP-HFpEF Efficacy Of Semaglutide In Patients With Obesity And HFpEF According To Frailty Status: A Pooled Analysis From The STEP-HFpEF Program Effects Of Semaglutide In Patients With Obesity-related Heart Failure With Preserved Ejection Fraction According To The Exercise Function At Baseline: Insights From The STEP-HFpEF Program FINEARTS-HF Efficacy And Safety Of Finerenone In Patients With Heart Failure And Mildly Reduced Or Preserved Ejection Fraction And A Recent Worsening Heart Failure Event: The FINEARTS-HF Trial Efficacy And Safety Of Finerenone Across The Ejection Fraction Spectrum In Heart Failure With Mildly Reduced And Preserved Ejection Fraction: The FINEARTS-HF Trial HELIOS-B Exploratory Analyses From HELIOS-B, A Phase 3 Study Of Vutisiran In Patients With Transthyretin Amyloidosis With Cardiomyopathy Title to be announced Monday, September 30 Plenary Session | 9:00 AM – 10:30 AM SEQUOIA-HCM Global Clinical Impact Of Aficamten In Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA-HCM EMBARK-HFpEF Myosin Inhibition In Heart Failure With Preserved Ejection Fraction: Primary Results Of The EMBARK HFpEF Trial ARIES-HM3 Impact Of Pharmacological Therapy On Hemocompatibility Following Left Ventricular Assist Device Implantation: An Analysis From The ARIES-HM3 Trial EXPANDed Atrial Secondary Mitral Regurgitation Outcomes Following Mitral Transcatheter Edge-to-Edge Repair With The MitraClip System HuMAIN-HFpEF A Novel Controlled Metabolic Accelerator For The Treatment Of Obesity-related Heart Failure With Preserved Ejection Fraction: HuMAIN-HFpEF Trial Late Breaking Clinical Research showcases novel results of major randomized trials and rapidly evolving research. Leaders of the field will serve as discussants, presenting brief comments about each trial to place them in context. Due to the quantity of remarkable trials submitted, HFSA will also feature late breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced and brief oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Saturday, Sunday and Monday with moderated Q&A and a new topic each day. Saturday, September 28 | Rapid Fire 1: Not Just Plug and Play: Devices and Health Technology in Heart Failure | 4:00 PM - 5:00 PM Interstitial Decongestion with Device-Based Thoracic Duct Decompression in Acute Decompensated Heart Failure Patients RECOVER-HFPilot Study: Synchronized Diaphragmatic Stimulation For HFrEF Therapy PROACTIVE HF: 12-Month Results Safety And Technical Endpoints And Accurate Volume Assessment Using An Implanted Inferior Vena Cava Sensor Electronic Alerts To Improve Heart Failure Therapy Throughout An Integrated Health System: Prompt-HF Inova Effect Of Finerenone On Kansas City Cardiomyopathy Questionnaire (KCCQ) Score In Heart Failure With Mildly Reduced And Preserved Ejection Fraction: The FINEARTS-HF Trial Sunday, September 29 | Rapid Fire 2: Birds of a Feather: Cardio-kidney-metabolism and HFpEF | 5:15 PM - 6:15 PM Efficacy And Safety Of Finerenone According To Age In Heart Failure With Mildly Reduced And Preserved Ejection Fraction: The FINEARTS-HF Trial The Effects Of Burst Steroid Therapy On Short Term Decongestion In Acute Heart Failure: The CORTAHF Randomized, Open-Label, Pilot Trial Effects Of Exogenous Ketone Therapy On Exercise Capacity In Heart Failure With Preserved Ejection Fraction: KETO-HFpEF Metabolic Responses To Exercise Following Weight Loss Surgery: WTLOSS-EX Trial Efficacy Of A Home-Based M-Health Cardiac Rehabilitation Program Among Older Adults With Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial Understanding The Real-World Management Of Patients With Heart Failure At Risk For Hyperkalemia: Initial Results From The CARE-HK In Heart Failure (HF) Registry Unsaturated Fatty Acids To Improve Cardiorespiratory Fitness In Obesity-Related Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Randomized Controlled Cross-over Study Monday, September 30 | Rapid Fire 3: See One, Do One: Emerging Therapeutic Strategies in Cardiomyopathies and Heart Failure | 10:45 AM - 11:45 AM A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study On The Safety And Efficacy Of Istaroxime For Pre-Cardiogenic Shock First In Human Gene Therapy For The Cardiomyopathy Of Friedreich Ataxia Differences In Self -care Of Heart Failure Index Among Patients With Heart Failure With And Without Symptom Coaching Messages: A Pilot Clinical Trial Study Efficacy Of Single Dose Furoscix Vs. Home Dose Furosemide In Patients Recently Hospitalized For Heart Failure Across Diuretic Resistance Strata: A Pilot Randomized Controlled Trial AuXillary OUTpatient Management Of VAD BLEEDing: The AXOUT VAD BLEED Pilot Study Pulmonary Artery Pressures In Relation To Serial Cardiovascular Blood Biomarkers In Chronic Heart Failure Patients American Registry Of Ambulatory Or Acute Decompensated Heart Failure (AMERICCAASS): Current Results The meeting kicks off in just three weeks. A full schedule at a glance is available online, as well as information on the science and research and networking available at the meeting. Learn more about the meeting and register at hfsa.org/asm2024. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America

临床3期

2024-09-04

·拜耳中国

拜耳非奈利酮显著改善常见成人心衰患者心血管结局

非奈利酮是一种非甾体选择性盐皮质激素受体（MR）拮抗剂，是首个在针对左心室射血分数（LVEF）≥40% ，即 LVEF 轻度降低或保留的心衰患者的III期临床研究中被证明有确切心血管获益的MR拮抗剂与安慰剂相比，非奈利酮将主要复合终点：心血管死亡和总心衰（首次和复发）事件的相对风险降低了16% 在所有预先设定的，包括基于合并症、住院状态、射血分数或SGLT2抑制剂基线使用情况的各亚组中，主要终点结果均一致 FINEARTS-HF研究结果同时在《新英格兰医学杂志》上发表 LVEF≥40%的心衰患者未满足的医疗需求很高，住院率和死亡率与LVEF≤40%的心衰患者相当，但目前针对这类患者获得批准并被指南推荐的治疗方法有限近日，拜耳非奈利酮的FINEARTS-HF III期研究详细结果在2024年欧洲心脏病学会年会（ESC）热线环节发布，结果表明：与安慰剂相比，非奈利酮显著改善左心室射血分数（LVEF）≥40%的心衰患者的心血管结局。在32个月的中位治疗期中，非奈利酮将心血管死亡和总（首次和复发）心衰事件（定义为心衰住院或心衰急诊）的主要复合终点风险显著降低16%（相对风险降低，RR为0.84 [95% CI, 0.74-0.95; p=0.0072] ）。据此，非奈利酮是首个在III期研究中被证实对常见心衰有确切心血管疗效的MR拮抗剂。FINEARTS-HF研究结果同时在《新英格兰医学杂志》上发表。哈佛医学院教授、布里格姆妇女医院无创心脏病学主任、研究执行委员会主席、医学博士Scott D. Solomon 说：“ LVEF≥40%的心衰患者治疗对许多医生都是重大挑战，因为这类患者有发生严重心血管事件的巨大风险，并且目前被证实有效的治疗方案有限。FINEARTS-HF研究是在这类心衰患者中开展的第一个评估非甾体类选择性盐皮质激素受体拮抗剂的大规模研究，一旦非奈利酮获得批准，有助于帮助这些脆弱患者。” 在此研究中，所有预设亚组在主要终点方面表现出一致获益，无论各亚组的背景治疗、合并症或住院情况如何，疾病状态（射血分数）或基线使用 SGLT2 抑制剂情况如何均如此。非奈利酮还显著降低次要终点心衰总事件（RR为0.82 [95% CI, 0.71-0.94; p=0.0062]），以及患者报告的健康状况改善，以堪萨斯城心肌病问卷（KCCQ-TSS）总症状评分与基线相比的变化来衡量（组间差异为1.6分 [95% CI, 0.8-2.3; p<0.0001]）。全世界有 6000 多万人受心衰影响，这些患者中约有一半是LVEF≥40%的心衰。LVEF≥40%的心衰与复杂疾病相关，这一人群不断增长，很快成为心衰住院患者中的大多数。LVEF≥40%的心衰患者住院率和死亡率与LVEF≤40%的患者（射血分数降低的心衰，HFrEF）相似，一半以上LVEF≥40%的心衰患者在5年内死亡。尽管有治疗方法，LVEF≥40%的心衰患者发生心血管事件和死亡的残余风险仍然很高。拜耳处方药事业部全球研发负责人Christian Rommel博士表示：“ 拜耳在心脏病领域基础深厚，心衰是我们重点关注方向，本次令人鼓舞的结果兑现了我们对这类严重疾病患者的持续承诺。在FINEARTS-HF研究中，非奈利酮改善难治患者群体的心血管结局，证明非奈利酮深具潜力。如果获得批准，它将成为射血分数轻度降低或保留的心衰患者的重要治疗选择，而且不受背景治疗和疾病状态的影响。FINEARTS-HF研究中住院或近期住院的患者比例很高，这意味着研究结果对于改善这些目前没有足够治疗选择患者的心血管结局具有重要意义。” 非奈利酮是一种非甾体选择性盐皮质激素受体（MR）拮抗剂。通过作用于过度激活的 MR和RAAS 系统，非奈利酮可解决LVEF≥40%心衰的疾病特征，如进行性纤维化问题。在FINEARTS-HF研究中，非奈利酮耐受性良好，与其公认的安全性特征相符。非奈利酮组与安慰剂组在治疗期出现的严重不良事件总发生率相当。与高钾血症相关的不良事件在非奈利酮组高于安慰剂组（分别为9.7%和4.2%）。两个治疗组均未发生致命高钾血症不良事件，因高钾血症住院或停药的情况也很少发生。非奈利酮组出现血钾和肌酐水平升高的频率更高，但血钾超过 6.0 mmol/L 的发生率普遍较低。拜耳计划在适当时间向各药品监管部门提交非奈利酮用于 LVEF≥40%的心衰患者的上市申请。 FINEARTS-HF是一项随机、双盲、安慰剂对照、多中心、事件驱动的III期研究，旨在评估非奈利酮预防心血管死亡和心衰事件的有效性和安全性，研究对象为诊断为症状性心衰（纽约心脏病协会II-IV级）、左室射血分数（LVEF）≥40%的患者、在过去12个月内接受过任何方式的测量，并在随机分组前至少30天接受过利尿剂治疗。FINEARTS-HF的主要终点是心血管死亡和全部（首次和复发）心衰事件的复合终点，心衰事件定义为心衰住院或因心衰急诊。全球37个国家的630多个研究机构约6000名患者被随机分组，接受每天一次非奈利酮或安慰剂治疗。此外，研究中的患者还接受针对症状和合并症的常规治疗。在32个月的中位持续时间内，每日一次非奈利酮将心血管死亡和总体（首次和复发）心衰事件（定义为心衰住院或心衰急诊）的复合风险大幅降低16%（相对风险降低， RR 0.84 [95% CI, 0.74-0.95; p=0,0072]）。主要终点各组成部分的结果如下：心血管死亡：HR 0.93 [95% CI，0.78-1.11]；总（首次和复发）心衰事件，定义为心衰住院或心衰急诊：RR 0.82 [95% CI, 0.71-0.94; p=0.0062]）。非奈利酮还显著降低次要终点：患者报告的健康状况改善，通过堪萨斯城心肌病问卷（KCCQ-TSS）症状总评分与基线相比的变化来衡量（组间差异为1.6分 [95% CI, 0.8-2.3; p<0.0001]）。在 NYHA 分级（OR 1.01 [95% CI, 0.88-1.15]）、复合肾脏结局（HR 1.33; [95% CI, 0.94-1.89]），或全因死亡（HR 0.93; [95% CI, 0.83-1.06]）方面，非奈利酮组与安慰剂组没有差异。正在进行的非奈利酮MOONRAKER （包括 FINEARTS-HF）临床研究项目共有15,000多名患者参加，是迄今为止规模最大的心衰研究项目之一，旨在全面了解非奈利酮针对心衰患者在临床中的广泛应用。可申达®（非奈利酮片）是一种非甾体选择性盐皮质激素受体拮抗剂，在临床前研究中显示可阻断盐皮质激素受体过度激活造成的有害影响。盐皮质激素受体过度激活被认为会通过靶器官的炎症和纤维化而导致慢性肾病进展和心血管受损。可申达®（非奈利酮片，10mg和20mg）于2022年6月在中国获批用于与2型糖尿病相关的慢性肾脏病成人患者（肾小球滤过率估计值[eGFR]≥25至<75mL/min/1.73m2，伴白蛋白尿），可降低eGFR持续下降、终末期肾病的风险，是首个获批用于与2型糖尿病相关慢性肾脏病的非甾体选择性盐皮质激素受体拮抗剂，作用在现有标准疗法未能触及的疾病进展关键因素。2023年5月，中国国家药品监督管理局（NMPA）批准将可申达®（非奈利酮片，10mg或20mg）的适用人群扩展到与2型糖尿病相关的慢性肾脏病早期阶段，并且适应症中纳入心血管相关获益（降低心血管死亡和因心衰住院的风险）。非奈利酮的研究项目中，FINEOVATE项目目前包括十个III期临床研究，分别针对心衰和慢性肾脏病；MOONRAKER项目包括 FINEARTS-HF研究，以及正在进行的由研究者发起的合作研究 REDEFINE-HF、CONFIRMATION-HF 和 FINALITY-HF。THUNDERBALL CKD项目包括已完成的FIDELIO-DKD和FIGARO-DKD研究，以及正在进行的FIND-CKD、FIONA、FIONA-OLE、FINE-ONE研究和II期CONFIDENCE研究。心力衰竭（心衰）是一种复杂的临床综合征，其特点是心脏泵血能力逐渐下降，无法满足人体对血液和氧气的需求。心衰影响全球6000多万人，是65岁以上人群住院治疗的主要原因。预计在未来十年内，心衰发病率将急剧上升，部分原因是人口老龄化。心衰的预后很差，死亡率与最常见的癌症相似，甚至更高。心衰可能因多种并发症而变得复杂，半数以上的患者同时患有肥胖、慢性肾脏病、糖尿病、高血压或房颤等疾病。心衰的症状可能包括头晕、气短、疲劳、睡眠障碍、胸部不适、水肿（脚和腿肿胀）以及慢性咳嗽或气喘。心衰的危险因素包括高血压、糖尿病、吸烟、既往心肌梗死和冠状动脉疾病。尽管治疗手段不断进步，但约有30%的确诊心衰患者会在一年内死亡，五年后死亡率会增至约40%。左心室射血分数（LVEF）是衡量心脏功能的指标，表示左心室每次收缩时泵出血液的多少，依此心衰分为三种类型：射血分数降低的心衰（HFrEF），其特征是心脏在收缩阶段充分射出富氧血液的能力受到影响，LVEF≤40%；射血分数轻度降低的心衰（HFmrEF），是指射血分数在41%至49%之间的患者。射血分数保留的心衰（HFpEF），特征是心脏僵硬，使得左心室无法充分松弛以补充血液，从而导致充盈异常，LVEF≥50。虽然 LVEF<40% 和 LVEF≥40% 的患者各占全部心衰患者一半左右，但 LVEF≥40%的患者心血管和非心血管合并症负担更重。时间趋势分析也表明，LVEF≥40%的心衰患者很快将占住院心衰患者的大多数。LVEF<40%的心衰患者的治疗已经取得了进展，但 LVEF≥40%的心衰患者目前治疗选择却很有限。拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。内容来源于网络，如有侵权，请联系删除。

临床结果临床失败

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	中国	Bayer AG	2021-02-03
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

评价

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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


NCT04435626 (FINEARTS-HF, BusinessWire) 人工标引	临床3期	心脏衰竭	-	finerenone (LVEF ≥40%)	餘淵製鏇顧膚鬱艱糧醖(窪願窪觸膚夢鏇齋壓鬱): 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%)
FINE-HEART (Company_Website) 人工标引	N/A	心脏衰竭 \| 慢性肾病	-	Finerenone	簾廠簾鏇襯積艱鏇衊獵(鏇積繭鏇繭觸鑰網窪鑰) = 憲觸顧廠夢壓選鏇鑰製築憲顧蓋選窪遞齋淵獵 (醖製遞醖獵網夢積憲築 ) 更多	积极	2024-09-01
				Placebo	簾廠簾鏇襯積艱鏇衊獵(鏇積繭鏇繭觸鑰網窪鑰) = 憲淵遞襯襯顧憲繭齋鹹築憲顧蓋選窪遞齋淵獵 (醖製遞醖獵網夢積憲築 ) 更多
NCT04435626 (FINEARTS-HF, Pubmed \| N Engl J Med)	临床3期	射血分数保留型心力衰竭	-	Finerenone 20 mg	廠壓淵簾膚選構顧網積(選網憲網築窪鬱顧築願) = increased risk 壓構選夢範鬱膚艱壓鹽 (願糧鹹醖膚範製簾餘齋 ) 更多	积极	2024-09-01
				Finerenone 40 mg
NCT04435626 (FINEARTS-HF, NEWS) 人工标引	临床3期	心脏衰竭	6,016	Kerendia	醖齋積襯衊鬱網積醖襯(夢壓範齋鑰積鏇遞獵醖) = Top-line results showed that compared to placebo, Kerendia was associated with a significant and clinically meaningful reduction in the trial’s main goal. 積餘築選淵獵簾壓蓋蓋 (獵選壓鹹構鬱糧淵廠窪 ) 达到更多	积极	2024-08-05
				Placebo
ISN WCN2024	临床3期	2型糖尿病 \| 慢性肾病	-	Finerenone	製壓鹽衊願簾繭鏇範網(壓遞鏇窪鏇齋築廠願遞) = low for finerenone (2.6%) and placebo (0.9%) 齋鏇淵壓選糧鑰獵鬱壓 (憲壓顧鏇糧選構糧積艱 ) 更多	积极	2024-04-01
				Placebo
FIDELIO-DKD and FIGARO-DKD (Pubmed \| Kidney Med)	N/A	2型糖尿病 \| 慢性肾病	-	Finerenone	鹽顧廠蓋餘構遞夢鏇齋(構廠餘遞築淵積願憲醖) = 願獵餘醖範糧餘願鬱憲鬱壓糧憲網遞遞窪構艱 (膚網鏇鏇鹽壓選糧餘製, 0.33 ~ 2.44)	积极	2023-12-01
				Placebo	鹽顧廠蓋餘構遞夢鏇齋(構廠餘遞築淵積願憲醖) = 蓋鏇繭構簾艱艱網遞糧鬱壓糧憲網遞遞窪構艱 (膚網鏇鏇鹽壓選糧餘製, 0.89 ~ 1.28)
FINE-REAL (Biospace) 人工标引	N/A	2型糖尿病 \| 慢性肾病	504	finerenone	鏇窪淵鏇選鹹壓衊齋觸(鏇衊願築繭築構鹽齋鬱) = 積簾網觸齋膚淵繭構簾齋製鏇觸鹹窪憲簾淵鹹 (糧鏇獵艱鬱襯憲積夢齋 ) 更多	积极	2023-11-04
NCT02545049 \| NCT02540993 (FIGARO-DKD, NEWS) 人工标引	临床3期	2型糖尿病肾脏病	-	Kerendia	繭醖鏇衊艱鏇壓網觸觸(積構鬱襯餘糧遞獵壓願) = In FIDELIO-DKD, Kerendia reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥ 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, P=0.001). In FIGARO-DKD, Kerendia reduced the incidence of the primary composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF (HR 0.87, 95% CI 0.76-0.98, P=0.026). 淵獵鹽窪夢觸餘艱醖鹹 (願壓範積夢獵選糧淵築 ) 更多	积极	2023-11-02
				Kerendia (FIDELIO-DKD)
NCT02545049 \| NCT02540993 (FIDELITY, EASD2023)	临床3期	2型糖尿病 \| 慢性肾病 UACR \| eGFR	-	Finerenone	願鬱壓衊壓鏇繭簾鏇壓(築顧範簾襯醖鏇鏇鬱齋) = 選蓋壓顧衊繭襯鹹觸醖網繭襯構壓鹽積顧餘獵 (餘範醖餘夢衊鹽鹽膚鏇, 0.77 ~ 0.90)	积极	2023-10-04
NCT02545049 (FIGARO-DKD, EASD2023)	临床3期	疾病进展	325	Finerenone	蓋艱積廠壓鏇壓膚顧鏇(鏇選廠構觸醖願醖製製) = Incidence of hyperkalaemia was higher in the Chinese population vs ROW (18.8% vs 8.0%), but similar between finerenone and placebo (19.1% vs 18.5%) 製淵製鹽繭鹽壓構鏇壓 (觸鹹願蓋蓋繭窪簾淵憲 ) 更多	积极	2023-10-04
				Placebo