A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease.
The main questions it aims to answer are:
* Is it safe to start these medicines over a short period of time?
* How often do kidney function changes or high potassium levels occur?
* Does this approach lower protein in the urine (a sign of kidney damage)?
* How many participants are able to stay on all four medicines over 6 months?
Researchers will compare this approach to usual care, where medicines are started one at a time over several months.
Participants will:
Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months

开始日期2026-04-30

申办/合作机构

Baylor Research Institute

CTIS2025-521780-12-00

/ Recruiting临床4期IIT

Withdrawal of neurohormonal therapy in patients with non-ischemic cardiomyopathy, no late gadolinium enhancement, and negative genetic testing, who have exhibited super-response to cardiac resynchronization therapy. DRUGLESS-CRT clinical trial.

开始日期2025-12-16

申办/合作机构-

100 项与厄贝沙坦相关的临床结果

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100 项与厄贝沙坦相关的转化医学

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100 项与厄贝沙坦相关的专利（医药）

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2,951

项与厄贝沙坦相关的文献（医药）

2026-12-31·RENAL FAILURE

Landscape of diabetic kidney disease drug clinical trials in China (2013–2023): global implications for innovation and policy

Review

作者: Xiao, Zheng ; Tan, Huifang ; Chen, Yinyin ; Zhu, Jiayu ; Li, Guoli ; Yang, Yiya

With the increasing prevalence of diabetes, the incidence rate of diabetic kidney disease (DKD) has risen yearly in China. While traditional therapies like renin-angiotensin system blockers remain foundational, the treatment paradigm is rapidly evolving with the emergence of novel agents, including SGLT2 inhibitors, mineralocorticoid antagonists, endothelin receptor antagonists, and GLP-1 receptor agonists. This study aims to provide an overview of the changing landscape of drug clinical trials on DKD in mainland China from 2013 to 2023. Detailed information of drug trials for DKD registered on the National Medical Products Administration Registration and Information Disclosure Platform for Drug Clinical Studies was collected. A total of 50 trials for DKD were included. Bioequivalence trials accounted for the most significant proportion (48%), followed by phase II (22%), phase I (20%), and phase III (10%). Chemical drugs accounted for the largest proportion (92%), followed by traditional Chinese medicine/natural medicine (8%). There were 18 different drugs involved in the 50 trials with Irbesartan (n = 24, 48%) ranked first in the number of trials. The parallel-group design was primarily used (48%), followed by crossover design (46%). Randomization was used by almost all trials (92%). Of all trials, 44 (88%) were launched domestically, whereas only 6 (12%) were international multi-center trials. Drug trials showed an uneven geographical distribution. Despite the progress in DKD drug clinical trials in mainland China during recent years, innovative drug research and development still has a long way to go. These findings provide an evidence base for optimizing global-regional alignment in DKD innovation policy.

2026-06-03·ACS Chemical Neuroscience

Chemokine-Receptor Modulation Shapes Neuroinflammatory and Biomechanical Responses in Organotypic Hippocampal Cultures After Oxygen-Glucose Deprivation

Article

作者: Basta-Kaim, Agnieszka ; Podestà, Alessandro ; Lekka, Małgorzata ; Trojan, Ewa ; Kubiak, Andrzej ; Bryniarska-Kubiak, Natalia

Ischemic stroke is a life-threatening neurological condition that frequently leads to severe brain damage and long-term disability. Current therapeutic options remain limited and are largely confined to anticoagulant-based interventions. Despite extensive evidence implicating inflammation in stroke pathogenesis, effective therapies targeting neuroinflammatory mechanisms are still missing. Given that chemokines and their receptors have been successfully targeted in clinical contexts outside stroke, we identified these signaling axes as promising candidates for therapeutic modulation in ischemic injury. We tested the hypothesis that pharmacological modulation of selected chemokine-receptor pathways alters the neuroinflammatory response and tissue viability following ischemia. Using organotypic hippocampal cultures subjected to oxygen-glucose deprivation, we demonstrate that inhibition of CX3CR1, CCR2, and CXCR4 differentially affects tissue viability under ischemic conditions. Owing to the pronounced biological effects observed upon CCR2 inhibition, we further investigated its mechanistic basis using atomic force microscopy. These analyses revealed that Irbesartan treatment is associated with cytoskeletal reorganization and significant alterations in the mechanical properties of ischemic brain tissue. In summary, our study establishes the organotypic hippocampal culture-oxygen-glucose deprivation model as a robust platform for investigating neuroinflammatory processes in ischemic stroke. We identify key chemokine-receptor circuits that modulate ischemic injury and uncover a previously underappreciated contribution of tissue biomechanics to the pathophysiological response to ischemia.

2026-06-02·ACS Omega

The State of Imidazolone as an Evolving Pharmacophore: Current Progress and Clinical Significance in Oncology and AMR

Review

作者: Paidesetty, Sudhir Kumar ; Mal, Suvadeep ; Panda, Preetesh Kumar ; Ghose, Aruna ; Mahapatra, Monalisa

Nitrogen-bearing heterocycles have been fundamental scaffolds in drug discovery, contributing significantly to the design and development of therapeutic agents since the inception of modern medicinal chemistry. Among them, imidazolones have shown notable therapeutic relevance, particularly in oncology, antimicrobial resistance (AMR), and inflammation, yet they remain relatively underexplored. Nevertheless, the significant therapeutic and clinical efficacy of imidazolone-bearing drugs, such as Nilutamide, Irbesartan, and Leucettinib-21, in anticancer, antihypertensive, and neurotherapeutic applications has stimulated increasing interest in imidazolone chemistry and its medicinal potential. This review systematically discusses the major synthetic strategies, structure-activity relationships, and mechanistic principles governing the biological activity of imidazolones. Particular emphasis is placed on their rapidly expanding role as anticancer agents targeting enzymes and signaling proteins such as carbonic anhydrases, epidermal growth factor receptors (EGFR), Bcl-2 protein family, and checkpoint kinases, along with their potential applications in antimicrobial and anti-inflammatory therapies. Furthermore, the review highlights the complementary roles of computational modeling and biological evaluation in understanding the interactions of imidazolone-bearing compounds with various microbial and cancer-related receptors. These integrated studies reveal their ability to engage multiple biological targets and validate their observed pharmacological activities. The convergence of in silico predictions with experimental findings offers valuable guidance for the rational development of imidazolone-based therapeutics. Overall, this review emphasizes imidazolones as promising scaffolds with significant potential for future drug discovery and development.

516

项与厄贝沙坦相关的新闻（医药）

2026-06-23

·中国中医药报官方号

中外专家关注经典植物药黄蜀葵花！2026年度专科前沿系列讲堂第六讲开讲

点击蓝字关注我们文｜本报记者黄心图｜江苏省中医院供图 6月18日，由江苏省中医院（南京中医药大学附属医院）主办的2026年度专科前沿系列讲堂第六讲开讲。本次讲堂集结中国、法国肾病领域专家学者，中西医、海内外思维碰撞，从经典植物药黄蜀葵花现代药理、循证大数据、人工智能跨界肾病科研等视角，深度拆解肾病临床与科研创新。会议现场。法国国立医药健康研究院院长、索邦大学肾脏病国家重点实验室主任CHRISTOS CHATZIANTONIOU作题为《基于现代药物研发时代对于黄葵的再思考》的报告。CHRISTOS 教授长期从事肾脏病理生理学、慢性肾脏病、肾纤维化及肾脏损伤修复机制研究。他的报告从2000多年前希腊人发现柳树可以治疗发热讲起，他说，传统经验提供起点，科学研究逐步明确转化价值：经验观察—化学解析—机制阐明—可成药性—临床定位。黄蜀葵花经历了从经验疗法到慢性肾病药物研发的过程。医药典籍记载黄蜀葵花具有利尿、消肿、解毒作用。后江苏省中医院发现其降低尿蛋白、改善水肿作用。黄蜀葵花逐渐被重新认识为肾脏疾病专科药物。1999年，黄蜀葵花提取物被开发为工业化、质量可控的标准化产品，近些年开展的慢性肾脏病/糖尿病肾病蛋白尿研究及国际合作进一步夯实其证据基础。 CHRISTOS 教授介绍，随机对照临床试验、大型单臂研究等证实，黄葵胶囊在多种慢性肾脏病试验中均显示出降低尿蛋白的治疗潜力。黄蜀葵花所含成分通过多个机制发挥肾脏保护效应：抑制炎症与免疫放大，抗肾脏纤维化、抑制基质重塑，抗氧化应激、细胞保护，调控细胞命运，调控肾脏代谢稳态。广东省中医院大数据研究团队主任苏国彬作题为《数智赋能肾病共病的中西医药联用的获益与风险评估》的报告。苏国彬教授介绍，数智驱动给中医药发展提供了新的机遇。国家重视大数据与人工智能发展，陆续发布相关政策。中西药联用临床常见，存在潜在获益与风险。肾病患者是中西药联用的重点人群，慢性肾脏病已经从“支持治疗”进入“多药联用”时代。肾脏疾病存在多病共存，中西药联用常见，是中西药联用获益与风险评估的理想病种。标准、数据、算法是制约利用真实世界数据开展“肾病患者”中西药联用评估的行业痛点。其团队解决痛点的举措是：制定中药饮片信息标准、建立CRDS真实世界数据库、建立中西药联用新算法。苏国彬作报告。东南大学肾病研究所副所长、中大医院肾科副主任王彬作题为《人工智能助力肾脏病药物研发》的报告。王彬介绍，AI可被应用于优化分子设计和提高临床试验效率。AI技术在靶标验证中的应用包括动态模拟和功能预测两大领域。AI推动老药新用改善疾病治疗困境。AI在肾脏病诊治中的应用包括：AI助力AKI（急性肾损伤）早期精准预测，肾脏病理的AI智能化等。我国首个肾脏病综合管理大模型——“智肾”整合36家三甲医院2000万患者全息医疗数据，学习最新指南、专家共识，以及中国人群真实世界证据。人工智能在药物研发中的优势：大数据处理能力强，能够整合多维度生物医学信息；机器学习算法可预测药物—靶点相互作用；虚拟筛选技术大幅提高先导化合物发现效率；显著缩短药物研发时间，降低研发成本。道阻且长，行则将至。AI的突破性贡献为：加速发现靶点、精准化生成分子、智能分层临床患者。尚待攻克的“三座大山”为：互作建模瓶颈、临床转化鸿沟、伦理困境。未来之路为：硅基智慧需与碳基智慧深度融合。技术层面，发展4D动态AI模型（融合分子动力学）；临床层面，将AI安全性评估纳入监管指南；伦理层面，推动可解释性AI成为药物申报必须模块，确保设计透明可控。王彬作报告。江苏省中医院肾内科主任何伟明作题为《基于“护肾延衰”理念中西医结合延缓慢性肾脏病进展的临床循证实践》的报告。何伟明教授介绍，慢性肾脏病是全球优先关注的重大非传染性疾病。全球慢性肾脏病患病率中位数为9.5%。慢性肾脏病在中国患病率高，知晓率低。全球范围内慢性肾脏病均造成沉重经济负担。全球慢性肾脏病（CKD）治疗已从传统对症管理迈入精准靶向、多药联用、全病程干预的循证新阶段。何伟明作报告。何教授介绍，黄葵胶囊是在中国被广泛用来治疗蛋白尿的一种中成药。其主要成分是黄蜀葵花提取物，明朝《本草纲目》载黄蜀葵“治五淋、水肿、消痈肿”。现代药理证实黄葵胶囊有多种保护肾功能的作用。中法国际合作开展了《黄葵胶囊联合厄贝沙坦片治疗2型糖尿病肾病蛋白尿的多中心、随机对照、双盲双模拟的临床研究》。研究显示：黄葵胶囊与厄贝沙坦疗效相当且更具优势，两者联用疗效更加显著。该讲堂得到了业界的广泛关注，超过1万人次观看了在线直播。欢迎关注！！ “中国中医药报”抖音号：36254766218 编辑｜王青云审核｜朱蕗鋆黄蓓

2026-06-23

·国际糖尿病idiabetes

亚洲创新驱动DPP-4抑制剂升级，开启双周降糖新路径

点击“蓝字”关注我们编者按我国2型糖尿病（T2DM）患者数量持续增长，且呈年轻化趋势。长病程患者常合并多种并发症及代谢异常，治疗依从性差、血糖长期不达标。如何简化方案、提高依从性，成为临床难点。随着我国自主研发的超长效二肽基肽酶-4（DPP-4）抑制剂问世，两周一次的口服降糖模式为破解这一困局提供了全新选择。本期，广东省中医院魏华主任中医师分享一例37岁、病程5年、已出现周围神经病变及早期肾损害的T2DM患者，合并高血压、高脂血症、高尿酸血症及肥胖，既往治疗极不规律。短期胰岛素泵强化后，采用考格列汀双周口服联合钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）/二甲双胍复方制剂，3个月后葡萄糖目标范围内时间（TIR）达99.7%。特邀哈尔滨医科大学附属第一医院匡洪宇教授从“治疗方案简化和代谢综合管理”视角进行点评，以期为类似病例提供参考。一、病例基本信息男性，37岁，主因“发现血糖升高5年，视力模糊6个月，下肢麻木3个月”就诊。现病史患者于5年前体检时发现血糖升高，无烦渴、多饮、多尿症状，当时空腹血糖8.6mmol/L，确诊为“2型糖尿病”，未予治疗。2年前因血糖升高于当地住院治疗（具体方案不详），出院后服用西格列汀100 mg每日一次、二甲双胍0.25 g每日三次、格列齐特分散片40 mg每日两次，未规律用药，未规律监测血糖。6个月前出现视力模糊，无眼花、重影，外院眼科予屈光矫正处理。3月余前间断出现双下肢麻木，无灼热、疼痛、踏棉花感。现为进一步治疗来我院。自发病以来精神、食欲、睡眠良好，大便稀溏，3~4次/日，体重无明显变化。既往史高甘油三酯血症10余年，未用药；高尿酸血症10余年，未用药；高血压病史3年余（最高值不详），不规律服用琥珀酸美托洛尔缓释片47.5mg每日一次联合硝苯地平控释片30mg每日一次。1年前因混合痔及肛周脓肿行“痔疮切除术”。否认肝炎、结核等传染病史。对鱿鱼过敏。预防接种史不详。个人史否认吸烟、饮酒史。家族史无特殊。体格检查体温36.5℃，心率88次/分，呼吸18次/分，血压163/112 mmHg。身高161 cm，体重71 kg，体重指数（BMI）27.39 kg/m2。腹部饱满，双下肢无水肿，双侧肌力、肌张力正常，腱反射正常。10 g尼龙丝试验阳性。实验室检查（表1）表1. 实验室检查辅助检查（表2）表2. 辅助检查临床诊断 T2DM伴血糖控制不佳 T2DM性周围神经病变 T2DM肾脏病（A2期）高血压病2级（极高危）混合性高脂血症高尿酸血症内脏脂肪型肥胖该病例特点总结如下患者为青年男性，超重（BMI 27.39 kg/m2），内脏脂肪型肥胖；病程5年，血糖长期控制不佳（HbA1c 9.1%，空腹血糖12.19 mmol/L，餐后2h血糖16.8 mmol/L），胰岛功能差（餐后C肽不升反降，空腹1.78 μg/L，餐后1.25 μg/L）；已出现周围神经病变（肌电图证实）及早期肾损害（UACR 57mg/g）；合并高血压（2级，极高危）、混合性高脂血症及高尿酸血症；既往治疗依从性差（未规律用药、未监测血糖）。二、住院治疗策略住院期间，患者接受持续皮下胰岛素输注（胰岛素泵）治疗，目的有二：一是快速解除高糖毒性，二是患者胰岛功能差、β细胞储备功能严重受损，需补充外源性胰岛素。同时，对患者进行糖尿病知识系统宣教。此外，同步实施降压、调脂、降尿酸综合管理，并予α硫辛酸营养神经治疗。三、出院后治疗方案调整患者经胰岛素泵强化后胰岛功能部分恢复，且年轻、无酮症倾向，转为口服方案。考虑既往依从性差，将原方案中的DPP-4抑制剂每天一次服用方案，替换为以考格列汀为核心的简化联合方案：给予考格列汀10 mg每2周1次联合SGLT2i/二甲双胍复方制剂每日1片。考格列汀作为我国自主研发的超长效DPP-4抑制剂，实现了从日制剂到双周制剂的跨越，低血糖风险低，不增重，两周一次给药显著减少服药频次，降低治疗负担。其他治疗：降压予厄贝沙坦+硝苯地平控释片（减少尿蛋白）；降脂调整为阿托伐他汀20 mg每晚1次（住院期间非诺贝特），目标LDL-C＜1.8 mmol/L；降尿酸予苯溴马隆，目标尿酸180~360 μmol/L；营养神经加用甲钴胺+依帕司他。四、出院随访结果出院后3个月复查，患者视物模糊症状消失，下肢麻木缓解，生活方式改善，用药依从性显著提高。体重由71 kg降至68 kg。动态葡萄糖监测（2026年4月2～16日）显示：平均葡萄糖6.3 mmol/L，变异系数（CV）16%，TIR 99.7%，高于目标范围时间（TAR）0.3%，低于目标范围时间（TBR）0%（图1）。图1. 血糖控制总览及动态葡萄糖图谱（AGP）专家点评哈尔滨医科大学附属第一医院匡洪宇教授：方案简化为先，兼顾心肾保护的双重破局。本例患者虽仅37岁，但已出现糖尿病周围神经病变及早期肾损害（UACR 57 mg/g），合并高血压、混合性高脂血症、高尿酸血症及内脏脂肪型肥胖，属代谢综合征重度聚集，心肾残余风险极高。同时，既往口服降糖方案为西格列汀（每日一次DPP-4抑制剂）、二甲双胍、格列齐特三药联合，每日6片分次服用，方案复杂，长期依从性极差，血糖持续失控。对此类患者，治疗策略须兼顾双重目标：首先简化方案，切实降低服药负担；同时超越单纯降糖，尽早启用兼具心肾保护的药物。而DPP-4抑制剂从日制剂向双周制剂的变革，为这一双重目标提供了关键支撑。出院后采用的“考格列汀10 mg每两周1片联合SGLT2i/二甲双胍复方制剂每日1片”方案，精准回应了上述需求。考格列汀作为我国自主研发的超长效DPP-4抑制剂，两周一次给药，大幅度减少给药次数（365→26次），打破了需要每日服药的限制。《考格列汀临床应用专家指导意见》指出，“考格列汀降糖疗效确切，安全性和耐受性良好，对体重影响中性”，且“考虑服药频次，生活不规律、治疗依从性差的T2DM患者可以优选考格列汀治疗”[1]。鉴于本病例患者既往用药依从性不佳，考格列汀双周给药的模式可大幅降低其服药频次与治疗负担，解决该患者因依从性不足导致的治疗效果不佳问题，极大地提升了用药便捷性和治疗依从性，具有重要的临床应用价值。其所联合的SGLT2i兼有减重、降压、降尿酸及降低尿蛋白排泄等心肾获益[2]。经治疗3个月后，动态葡萄糖监测示TIR高达99.7%，CV仅16%，全程无低血糖，超过了国际共识推荐的TIR>70%、CV≤36%的目标[3]。患者出院转换为两周一次的考格列汀后，服药依从性发生根本改善，血糖控制质量大幅提升。该病例提示，对于治疗负担重、并发症提前的年轻T2DM患者，以简化方案为先，以心肾保护为基，选用超长效DPP-4抑制剂两周一次口服方案做“减法”，使代谢综合管理与方案简化协同发力，是提高长期血糖达标率的务实策略。专家简介匡洪宇教授哈尔滨医科大学附属第一医院哈尔滨医科大学附属第一医院内分泌科主任/内科教研室主任二级教授博士研究生导师首届龙江名医中华医学会糖尿病学分会副主任委员兼视网膜病变学组组长中国医师学会内分泌代谢医师分会常委中国健康管理学会糖尿病防治与管理专业委员会副主任委员中国研究型医院学会糖尿病学专业委员会副主任委员中国老年保健医学研究会老年健康教育分会副主任委员中国医学基金会内分泌专业委员会副主任委员兼副秘书长中国1型糖尿病联盟副主席中国女医师协会副会长黑龙江省医学会糖尿病学会主任委员黑龙江省糖尿病临床医学研究中心主任黑龙江省女医师协会会长《中华糖尿病杂志》《中国糖尿病杂志》《国际内分泌代谢杂志》《diabetescare中文版》《diabetologia中文版》《lancetdiabetes&endocrinology中文版》《endocrinereviews中文版》等杂志编委。魏华主任中医师广东省中医院主任中医师，广东省中医院大德路总院内分泌科主任首批国医大师路志正学术继承人。世界中医药学会联合会脉象研究专业委员会副会长中华中医药学会糖尿病专业委员会常务委员广东省中医药学会“长桑君脉学”专业委员会主任委员广东省中西医结合学会慢病防治及管理专业委员会副主任委员广东省中西医结合学会代谢病分会副主任委员广东省保健协会甲状腺保健分会副主任委员广东省卫生信息网络学会糖尿病大数据分会副会长等主持及参与相关课题研究项目50余项，主编和参编专著及教材30余部，在国内外发表学术论文100余篇，先后获得广州中医药大学、广东省科技厅、广东省人民政府及中华中医药学会、中国中西医结合学会等多项科技进步奖及广州市人民政府、广东省人民政府抗非先进个人和三等功、“广东最强科室实力中青年专家”、“羊城好医生”等奖励和荣誉。参考文献[1] 《考格列汀临床应用专家指导意见》专家组, 等. 中国实用内科杂志,2024, 44(11): 917-920.[2] Heerspink HJL, et al. N Engl J Med, 2020, 383(15): 1436-1446.[3] Battelino T, et al. Diabetes Care, 2019, 42(8): 1593-1603. 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。

2026-06-23

·chugai-pharm.co.jp

Chugai Files New Drug Application in Japan for Sparsentan for the Treatment of IgA Nephropathy

June 19, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed a regulatory application with the Ministry of Health, Labour and Welfare for sparsentan for the treatment of patients with IgA nephropathy. “In IgA nephropathy, a designated intractable disease, there are patients in whom proteinuria is not adequately controlled with existing treatments, and long-term decline in kidney function has remained an unmet challenge. Sparsentan has a novel mechanism of action that inhibits both the endothelin receptor and angiotensin II receptor, and has demonstrated a significant reduction in proteinuria in clinical studies, with results suggesting a potential benefit in preserving kidney function. Together with the convenience of once-daily dosing, we aim to support long-term disease management for patients and contribute to establishing a treatment foundation for IgA nephropathy,” said Dr. Osamu Okuda, President and CEO of Chugai. This application is based on the results from the global Phase III study (the PROTECT study) conducted outside of Japan and Japanese Phase III study (the RE-021-001 study), both conducted in patients with IgA nephropathy with persistent presence of proteinuria.In the global Phase III study (PROTECT study), sparsentan demonstrated a statistically significant improvement in the primary endpoint—the percent change from baseline in urine protein/creatinine ratio (UPCR) at Week 36—compared with the active control irbesartan (−49.8% vs −15.1%, p<0.0001). In addition, results of the key secondary endpoint, the total slope of estimated glomerular filtration rate (eGFR) over time, suggested a potential long-term benefit in preserving kidney function. Sparsentan was generally well tolerated, and its safety profile was consistent with data from previous clinical studies. In the sparsentan group, treatment-emergent adverse events observed during the double-blind period included hypotension, hyperkalemia, dizziness, and peripheral edema. In the Japanese Phase III study (the RE-021-001 study), the primary endpoint—the percent change from baseline in urine protein/creatinine ratio (UPCR) at Week 36—achieved −58.5% reduction, consistent with the findings from the global Phase III study (the PROTECT study), demonstrating efficacy in Japanese patients. The safety profile was consistent with previously known findings, and no new safety signals specific to Japanese patients were identified. [Reference] Notice Concerning Making Renalys Pharma, Inc. a Wholly-Owned Subsidiary (News release issued on Oct 24, 2025) https://www.chugai-pharm.co.jp/english/news/detail/20251024170000_1197.html The PROTECT study is an international, multicenter, double-blind, active-controlled trial conducted by Travere Therapeutics outside Japan, in patients with IgA nephropathy who have persistent overt proteinuria despite treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). The primary endpoint was the percent change from baseline in urine protein/creatinine ratio (UPCR) at Week 36. Key secondary endpoints included the slope of eGFR from Week 6 to Week 110 and from Day 1 to Week 110. The RE-021-001 study is a multicenter, open-label, single-arm Phase III clinical trial conducted in Japan to evaluate the efficacy and safety of sparsentan in Japanese patients with IgA nephropathy. A total of 35 patients were enrolled in the study. The primary endpoint was the percent change from baseline in the urine protein/creatinine ratio (UPCR) at Week 36. Secondary endpoints included the change in eGFR at two years and safety assessments. Sparsentan is an oral, small molecule that inhibits both endothelin receptor type A (ETAR) and angiotensin II type 1 receptor (AT1R) in a single molecule. By simultaneously inhibiting the endothelin pathway in addition to the renin–angiotensin (RA) system, Sparsentan has been shown to provide a more potent reduction in proteinuria, while maintaining once-daily dosing similar to conventional RA system inhibitors.Sparsentan was granted full approval as FILSPARI for the treatment of IgA nephropathy in the United States in September 2024 and standard marketing authorization in Europe in April 2025, based on efficacy and safety data from the global Phase III study (the PROTECT study) in adults with IgA nephropathy conducted in 18 countries, including South Korea and Taiwan. In addition, in April 2026, FILSPARI was approved in the United States to reduce proteinuria in adult and pediatric patients 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. FSGS is a rare kidney disease also characterized by elevated proteinuria. IgA nephropathy (designated intractable disease No. 66) is a type of chronic glomerulonephritis characterized by the persistent presence of hematuria and proteinuria, caused by the deposition of abnormal immunoglobulin A (glycosylation-aberrant IgA) in the glomeruli of the kidneys1. Disease progression can lead to a decline in kidney function, and kidney transplantation or dialysis may become necessary when end-stage renal disease occurs2. In Japan, the number of patients is estimated to be approximately 33,0003, and it is known that approximately 40% of patients progress to end-stage renal disease within 20 years of diagnosis4. Existing treatments, such as renin-angiotensin (RA) system inhibitors or corticosteroids, may not sufficiently prevent disease progression in some patients, highlighting the need for new treatment options with greater efficacy. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准

100 项与厄贝沙坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00523	厄贝沙坦	C09CA04	DB01029

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	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	2005-05-18
高血压	美国	Sanofi-Aventis U.S. LLC	1997-09-30
2型糖尿病肾脏病	美国	Sanofi-Aventis U.S. LLC	1997-09-30
原发性高血压	欧盟	Sanofi Winthrop Industrie SA	1997-08-26
原发性高血压	冰岛	Sanofi Winthrop Industrie SA	1997-08-26
原发性高血压	列支敦士登	Sanofi Winthrop Industrie SA	1997-08-26
原发性高血压	挪威	Sanofi Winthrop Industrie SA	1997-08-26
肾脏疾病	欧盟	Sanofi Winthrop Industrie SA	1997-08-26
肾脏疾病	冰岛	Sanofi Winthrop Industrie SA	1997-08-26
肾脏疾病	列支敦士登	Sanofi Winthrop Industrie SA	1997-08-26
肾脏疾病	挪威	Sanofi Winthrop Industrie SA	1997-08-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
高胆固醇血症	临床3期	德国	Bristol Myers Squibb Co.	2009-11-01
肝纤维化	临床3期	法国	Sanofi	2006-10-01
慢性丙型肝炎	临床3期	法国	Sanofi	2006-10-01
急性冠状动脉综合征	临床3期	美国	Sanofi	2006-02-01
急性冠状动脉综合征	临床3期	美国	Bristol Myers Squibb Co.	2006-02-01
急性冠状动脉综合征	临床3期	比利时	Sanofi	2006-02-01
急性冠状动脉综合征	临床3期	比利时	Bristol Myers Squibb Co.	2006-02-01
急性冠状动脉综合征	临床3期	加拿大	Bristol Myers Squibb Co.	2006-02-01
急性冠状动脉综合征	临床3期	加拿大	Sanofi	2006-02-01
急性冠状动脉综合征	临床3期	法国	Bristol Myers Squibb Co.	2006-02-01

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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


NCT02597361 (Pubmed \| Circulation)	临床3期	Ehlers-Danlos综合征 defective type III collagen	-	Irbesartan 150 mg/day titrated to 300 mg/day	醖願糧鬱齋遞積醖網簾(構積糧鹽願鏇醖淵鹽淵) = Eleven episodes of irbesartan-related hypotension were recorded, leading to a downtitration in 4 patients 網築醖選積觸廠遞網範 (遞壓衊蓋艱獵蓋襯醖製 ) 更多	积极	2025-03-11
				Placebo
NCT00933231 (Phase 3b trial, Pubmed \| Clin Transplant)	临床3期	肾移植排斥反应	281	Standard-Dose Prolonged-Release Tacrolimus + ACEi/ARB	願簾鏇餘築廠醖簾遞簾(構顧顧衊糧糧範遞範醖) = 壓築簾範願鑰艱鹹齋糧鑰淵艱簾齋壓願願鹹範 (醖積鏇糧糧鑰網鏇構衊 ) 更多	积极	2025-01-01
				Standard-Dose Prolonged-Release Tacrolimus + Other Antihypertensive Therapy	願簾鏇餘築廠醖簾遞簾(構顧顧衊糧糧範遞範醖) = 壓廠鑰夢簾鑰衊鑰廠餘鑰淵艱簾齋壓願願鹹範 (醖積鏇糧糧鑰網鏇構衊 ) 更多
NCT05476354 \| NCT05475665 (I-DUO 301;I-DUO 302, Pubmed \| Clin Ther)	临床3期	原发性高血压	428	Irbesartan/Amlodipine 150/5 mg	蓋鹹艱選積膚糧鬱鏇艱(窪鏇鑰廠遞壓鬱壓鑰築) = 襯鏇醖夢繭遞糧繭網襯壓餘膚艱窪壓鹹餘製鑰 (齋獵糧獵獵觸鬱蓋遞繭, 12.35)	积极	2024-06-01
				Irbesartan/Amlodipine 150/10 mg	蓋鹹艱選積膚糧鬱鏇艱(窪鏇鑰廠遞壓鬱壓鑰築) = 壓製膚衊網糧鑰衊糧壓壓餘膚艱窪壓鹹餘製鑰 (齋獵糧獵獵觸鬱蓋遞繭, 12.78)
NCT03762850 (PROTECT, ISN WCN2024) 人工标引	临床3期	免疫球蛋白a肾病	404	Sparsentan 400 mg/day	壓積網範鏇製鬱構鹽觸(淵餘醖觸網壓壓構淵膚) = 餘糧鬱遞壓繭壓繭鬱鏇膚蓋選淵製蓋艱積壓餘 (獵積醖憲築蓋獵築壓選 ) 更多	积极	2024-04-01
				irbesartanirbesartan 300 mg/day	壓積網範鏇製鬱構鹽觸(淵餘醖觸網壓壓構淵膚) = 齋製夢窪餘繭夢選鏇製膚蓋選淵製蓋艱積壓餘 (獵積醖憲築蓋獵築壓選 ) 更多
NCT00791830 (Pubmed \| BMC Nephrol)	临床3期	血液透析并发症	81	Placebo	夢廠窪憲醖夢選餘鹹衊(繭鏇壓襯築鏇壓鬱襯齋) = 簾選構壓鹽觸構獵鹹糧築鏇鹽獵蓋築膚鏇鏇艱 (製淵衊壓繭壓廠範鹽衊 ) 更多	-	2020-10-28
				Angiotensin II receptor blocker (ARB)	夢廠窪憲醖夢選餘鹹衊(繭鏇壓襯築鏇壓鬱襯齋) = 獵觸艱鹹鬱築蓋選艱廠築鏇鹽獵蓋築膚鏇鏇艱 (製淵衊壓繭壓廠範鹽衊 ) 更多
PARCERIA STUDY (ESH2018)	N/A	高血压	509	Amlodipine/Irbesartan fixed combination	醖鏇襯齋簾壓醖憲膚網(鬱構鹽鑰襯鏇憲衊顧襯) = There were 124 Treatment Emergent Adverse Events (TEAEs) experienced by 89 (17.5%) patients, including 7 serious TEAEs by 5 (1.0%) patients. TEAEs were not related to A/I (76.6%) 願製艱構膚顧壓積製鏇 (膚襯範範鏇觸網艱製廠 )	积极	2018-06-01
NCT00095238 (I-Preserve Trial, Pubmed \| Circulation)	临床3期	射血分数保留型心力衰竭	4,128	Irbesartan (Patients with diabetes mellitus)	繭夢襯醖積餘鑰鹽構憲(廠窪鑰鹹鏇網鬱夢餘壓) = 蓋襯鏇鏇積艱齋簾鹹糧鹽選窪膚範鑰餘願獵繭 (鏇製壓鹹夢顧膚選齋衊 ) 更多	-	2017-02-21
				Irbesartan (Patients without diabetes mellitus)	繭夢襯醖積餘鑰鹽構憲(廠窪鑰鹹鏇網鬱夢餘壓) = 簾鑰壓餘衊窪醖遞鹽築鹽選窪膚範鑰餘願獵繭 (鏇製壓鹹夢顧膚選齋衊 ) 更多
NCT01442987 (Pubmed \| Clin Ther)	临床3期	高血压 \| 高胆固醇血症	230	Irbesartan 300 mg + Atorvastatin 40 mg	網遞夢顧觸繭壓衊簾膚(築齋遞醖範憲餘鬱壓壓) = 繭餘夢鑰選積鏇餘築夢艱夢鏇餘鑰選鬱網觸構 (艱夢選膚鏇膚願獵築壓, 2.06) 更多	-	2016-10-01
				Irbesartan 300 mg + Atorvastatin 80 mg	網遞夢顧觸繭壓衊簾膚(築齋遞醖範憲餘鬱壓壓) = 觸糧襯齋淵積襯糧衊築艱夢鏇餘鑰選鬱網觸構 (艱夢選膚鏇膚願獵築壓, 2.12) 更多
NCT00389168 (SILVHIA, CTgov)	临床2/3期	左心室肥大 \| 高血压	115	Atenolol (Atenolol)	餘蓋齋鏇製鹹襯簾獵衊(鬱鬱衊製壓淵膚積襯糧) = 憲網蓋築餘齋艱願鹹鑰襯築醖齋窪簾艱艱齋齋 (獵餘餘鬱築積糧廠築鹹, 製鑰築鑰積膚網膚齋艱 ~ 獵鹹鹹遞鏇蓋製膚鬱鑰) 更多	-	2015-05-05
				Irbesartan (Irbesartan)	餘蓋齋鏇製鹹襯簾獵衊(鬱鬱衊製壓淵膚積襯糧) = 積蓋選齋繭觸齋觸襯廠襯築醖齋窪簾艱艱齋齋 (獵餘餘鬱築積糧廠築鹹, 糧衊選壓醖廠願積繭齋 ~ 築蓋淵糧鏇艱構糧鏇遞) 更多
NCT00353652 (CTgov)	临床4期	高血压 \| 原发性高血压	166	Chlorthalidone (CTD) (Study#1: Chlorthalidone (CTD), Titrated Dose)	夢積願願獵網簾製願獵(餘餘構製膚獵繭鬱憲選) = 衊膚餘獵範鬱鹽艱觸齋憲選築壓願膚艱醖廠鬱 (鏇衊憲鏇獵鹽鬱繭願獵, 4) 更多	-	2014-12-29
				Spironolactone (SP) (Study #1: Spironolactone (SP), Titrated Dose)	夢積願願獵網簾製願獵(餘餘構製膚獵繭鬱憲選) = 顧窪糧蓋製製餘齋膚積憲選築壓願膚艱醖廠鬱 (鏇衊憲鏇獵鹽鬱繭願獵, 3) 更多