A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension

The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.

开始日期2025-02-28

申办/合作机构

Mineralys Therapeutics, Inc.

NCT06150924

/ Completed临床2期

A Randomized, Crossover, Double Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors, in Adults With Hypertension and Chronic Kidney Disease With Albuminuria

This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor [ASI]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.

开始日期2023-12-14

申办/合作机构

Mineralys Therapeutics, Inc.

NCT05968430

/ Active, not recruiting临床3期

An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

开始日期2023-07-14

申办/合作机构

Mineralys Therapeutics, Inc.

100 项与 Lorundrostat 相关的临床结果

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100 项与 Lorundrostat 相关的转化医学

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100 项与 Lorundrostat 相关的专利（医药）

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项与 Lorundrostat 相关的文献（医药）

2026-12-31·BLOOD PRESSURE

Effect of fourth-line antihypertensive therapy on clinic systolic blood pressure in resistant hypertension: a systematic review and meta-analysis

Review

作者: Un Nisa, Noor ; Alam, Taha ; Jawed, Hira Arshad ; Rajdeep, Dhvanit ; Ibrahim, Taha ; Saad, Muhammad ; Jamshaid, Zainab ; Hussain, Muhammad ; Hassan, Muhammad ; Kamal, Sohaima ; Hotak, Rafiullah

INTRODUCTION/BACKGROUND:

Resistant hypertension (rHTN) is defined as uncontrolled blood pressure despite ≥3 antihypertensives, including a diuretic. While fourth-line-intensification is recommended, comparative evidence remains scattered.

RESEARCH QUESTIONS/HYPOTHESIS:

To evaluate the efficacy and safety of fourth-line antihypertensives in reducing clinic systolic blood pressure (SBP) in rHTN.

METHODS/APPROACH:

PubMed, Embase, Scopus, and Web of Science were searched (2015-2026) for randomized controlled trials (RCTs) with ≥4 weeks follow-up. Risk of bias was assessed using Cochrane RoB 2. A planned network meta-analysis was not performed because statistical inconsistency and transitivity violations rendered indirect comparisons unreliable. Therefore, pairwise meta-analyses were conducted using random-effects models, with results reported as mean differences (MD) or risk ratios (RR) with 95% confidence intervals (CIs).

RESULTS/DATA:

Eleven RCTs involving 3,931 adults with rHTN were included. Compared with placebo, the largest SBP reductions were observed with lorundrostat (MD -11.70 mmHg [95% CI -16.07, -7.33]) and baxdrostat 2 mg (MD -10.10 [-12.63, -7.58]). Baxdrostat 1 mg (MD -8.56 [-11.08, -6.04]) produced reductions similar to spironolactone (MD -7.95 [-10.10, -5.80]). Bisoprolol achieved a modest SBP reduction (MD -6.71 mmHg), whereas aprocitentan 12.5 mg reduced SBP by -3.80 mmHg [-6.65, -0.95]. No intervention significantly increased serious adverse events. Higher rates of any adverse events were observed with aprocitentan 25 mg (RR 1.89 [1.39, 2.57]) and doxazosin (RR 1.55 [1.09, 2.20]).

CONCLUSIONS:

Aldosterone-targeted therapies, including aldosterone-synthase inhibitors and spironolactone, provide clinically meaningful SBP reductions in rHTN without increasing serious adverse event risk. Future trials should clarify comparative efficacy and long-term outcomes.

2026-07-01·AMERICAN JOURNAL OF HYPERTENSION

Lorundrostat for Patients With Uncontrolled Hypertension: A Systematic Review With Meta-Analysis and Trial Sequential Analysis

Review

作者: Schneider, Jamil Cherem ; Machado, Rafael Henkes ; Neves, Henrique Alexsander Ferreira ; Ribeiro, Vicente Morales ; Cavalcante, Douglas Nunes ; de Souza, Kevlin ; Camacho, Giovanna Cristina Gonçalves ; Bortolotto, Luiz Aparecido ; Celkevicius, Hermes Estevam Torega ; Lopes, Lucca Moreira ; Donaldy, Webster

Abstract:

Background:

The efficacy and safety of lorundrostat, a selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension remain unclear. This meta-analysis aimed to evaluate its effects on blood pressure and risk of hyperkalemia.

Methods:

PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were systematically searched through July 2025 for randomized controlled trials comparing lorundrostat with placebo. Pooled mean differences (MD) and risk ratios (RR) with 95% CIs were estimated using a random-effects model with the Restricted Maximum Likelihood estimator. Trial sequential analysis (TSA) was conducted to assess the conclusiveness of safety evidence.

Results:

Three RCTs including 1060 patients were identified. Lorundrostat significantly reduced systolic blood pressure at 50 mg (MD, −9.08 mmHg; 95% CI, −13.14 to −5.03) and 100 mg (MD, −11.41 mmHg; 95% CI, −15.97 to −6.85), and diastolic blood pressure at 50 mg (MD, −3.48 mmHg; 95% CI, −5.98 to −0.98). However, lorundrostat increased the risk of hyperkalemia at 50 mg (RR, 6.56; 95% CI, 1.53-28.12; NNH = 71) and 100 mg (RR, 10.37; 95% CI, 2.44-44.03; NNH = 42). TSA confirmed hyperkalemia at 100 mg as the only conclusive harm signal, while other safety outcomes remained inconclusive.

Conclusions:

Lorundrostat effectively lowered blood pressure but increased dose-dependent risk of hyperkalemia. These findings support its potential as a novel therapy for uncontrolled hypertension, while emphasizing the need for longer-term cardiovascular outcome trials and direct comparisons with mineralocorticoid receptor antagonists concerning efficacy and safety.

2026-07-01·HYPERTENSION RESEARCH

Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection

Review

作者: Nishimoto, Mitsuhiro ; Sato, Atsuhisa

Abstract:

Hypertension and organ damage caused by an inappropriate balance between aldosterone and salt are deeply involved in pathologies such as chronic heart failure, chronic kidney disease, and vascular disorders. Mineralocorticoid receptor antagonists are effective not only as antihypertensives, but also as organ-protective drugs, blocking direct aldosterone-induced organ damage independent of blood pressure. In recent years, research into selective aldosterone synthase inhibitors has progressed, resulting in the development of drugs such as baxdrostat, lorundrostat, and vicadrostat. These drugs are highly selective for aldosterone synthase with little inhibition of 11β-hydroxylase, making them promising antihypertensive and organ-protecting drugs. This article summarizes the basic and clinical research on aldosterone synthase inhibitors to date and reviews their characteristics. Aldosterone synthase inhibitors are drugs with the unprecedented characteristic of reducing blood aldosterone levels. Many studies have shown that low serum aldosterone levels are associated with a reduced risk of cardiovascular events. In fact, clinical trials of aldosterone synthase inhibitors have shown that lowering serum aldosterone levels by 50–70% results in lower blood pressure and organ protection. Even a small reduction in serum or local aldosterone levels is highly likely to improve hypertension and organ damage. Clinically, lowering blood aldosterone levels is very important.　Compared to the clinical evidence for mineralocorticoid receptor antagonists, clinical evidence for aldosterone synthase inhibitors remains insufficient. How these two drug types should be used given their differences thus remains unresolved. Discussing the differences in clinical effects in the future is thus important.

224

项与 Lorundrostat 相关的新闻（医药）

2026-08-26

·BioSpace

Mineralys Therapeutics to Participate in the Wells Fargo 21st Annual Healthcare Conference

RADNOR, Pa., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone, announced today that management will be participating in the Wells Fargo 21st Annual Healthcare Conference being held in Boston on September 8-10, 2026. Wells Fargo 21st Annual Healthcare Conference Date: Wednesday, September 9, 2026 Time: 4:30pm EDT Format: Fireside Chat Webcast Link: Click Here A live webcast of this fireside chat can also be accessed on the “ News & Events ” page in the Investor Relations section of the Mineralys Therapeutics website. About Mineralys Therapeutics Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit . Follow Mineralys on LinkedIn , X and Bluesky . Contact: Investor Relations investorrelations@mineralystx.com

2026-08-20

·新药研发信息

富马酸立康可泮胶囊获批用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者

琥珀酸思普可泮片医保申报信息海思科的琥珀酸思普可泮片（HSK39297）在国内获批富马酸立康可泮（HRS-5965）胶囊上市申请获得受理；伊普可泮胶囊2025年销售额已达5.05亿美元海思科的HSK39297片已报产，可参照盐酸伊普可泮来看本品种海思科的HSK39297--多适应症，重磅在研品种勃林格殷格翰的维卡司他Vicadrostat，用于肾脏-心脏代谢疾病中美华东申请了“Conveglipron+恩格列净”的复方组合物国际专利，用于治疗和/或预防代谢或肾脏类疾病非奈利酮片新适应临床结果越好，阿斯利康的Balcinrenone达格列净胶囊的市场前景就越好拜耳非奈利酮片用于非糖尿病慢性肾脏病成人患者的上市申请获得CDE承办 GlomCon基金会与大冢制药（Otsuka）联合启动REIGNITE项目，旨在推进IgA肾病（IgAN）领域的真实世界证据研究斯贝利单抗将肾功能下降稳定在基线生理速率水平，从根本上改变了IgA肾病（IgAN）的疾病进展拜耳在国内提交了非奈利酮用于非糖尿病慢性肾脏病成人患者的上市申请斯贝利单抗注射液医保申报信息阿塞西普注射液即将在美国获批，用于治疗IgA肾病，提升治疗标准布地奈德肠溶胶囊，鹬蚌相争，渔翁得利斯贝利单抗注射液（皮下注射）在国内获批，用于降低存在疾病进展风险的原发性免疫球蛋白A肾病（IgAN）成人患者的蛋白尿诺华公布了盐酸阿曲生坦片 III期ALIGN研究的最终2.5年随访结果 Povetacicept,Ⅲ期临床试验结果积极，同类最佳；为IgA肾病治疗药物增加了新的好药中国成人IgA肾病及IgA血管炎肾炎临床实践指南（2025） IgA肾病治疗药物精准医疗时代 IgA 肾病治疗的革新：诊断方法、不断发展的指南和新兴疗法布地奈德肠溶胶囊4mg 赛法色生sefaxersen注射液--用于IgA肾病的反义核苷酸药物盐酸阿曲生坦片预计2027年可以纳入参比制剂目录 Rectify 与勃林格殷格翰合作，推进慢性肾病首创疗法的研发勃林格殷格翰的BI764198（apecotrep）--用于蛋白尿性肾小球疾病布地奈德肠溶胶囊4mg仿制药获批；云顶新耀发布声明用于难治性高血压的巴曲司他片年销售额预测阿斯利康的巴曲司他片 Baxfendy已在美国获批，用于治疗难治性高血压醛固酮合成酶抑制剂研究进展阿斯利康在中国报产了巴曲司他片--用于难治性高血压用于难治性高血压的巴曲司他片（Baxdrostat）--已获得FDA优先审查权 lorundrostat(洛伦卓司他)的新药上市申请已获得FDA受理，拟用于难治性高血压近日，成都盛迪（恒瑞子公司）的富马酸立康可泮胶囊在国内获批用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者：截至目前，国内已获批的CFB抑制剂(补体因子B抑制剂)结构如下： HSK39297是海思科的思普可泮盐酸伊普可泮胶囊最早在中国获批上市的一款补体因子B抑制剂，目前获批的适应症为如下：适用于治疗： ·阵发性睡眠性血红蛋白尿症(PNH)成人患者。 ·C3肾小球病(C3G)成人患者，以降低蛋白尿。降低有疾病快速进展风险的原发性免疫球蛋白A肾病（IgA肾病）成人患者的蛋白尿水平用于治疗原发性免疫球蛋白A肾病（IgA肾病）。盐酸伊普可泮胶囊国内院内销售情况： - 诺华公司的 Fabhalta（iptacopan，盐酸伊普可泮胶囊）在 IgA 肾病 (IgAN) 试验中显示出 38.3% 的蛋白尿减少，表明两年内肾功能下降速度减缓。 - 该药物于 2024 年获得 FDA 加速批准用于治疗 IgAN，目标是在 2026 年获得传统批准，目标市场规模为 38.7 亿美元，预计到 2034 年将以 30.5% 的复合年增长率增长。 - 作为首个获得 FDA 批准用于治疗 C3G 和 aHUS 的口服疗法，Fabhalta 的安全性和先发优势使其有望在 2032 年之前主导价值 4550 亿美元的罕见病市场。 - 诺华公司预计Fabhalta的销售峰值将达到30亿美元，并计划将其产品线扩展到狼疮性肾炎领域，利用Fabhalta相对于Soliris等注射剂竞争对手的差异化优势，加强其肾脏产品组合。三期临床试验成功：临床疗效和安全性是战略资产 APPLAUSE-IgAN试验的成功之处在于它双重证明了Fabhalta既能降低蛋白尿（肾损伤的关键生物标志物），又能长期保护肾功能。9个月时蛋白尿降低了38.3%，24个月时eGFR斜率也得到了显著改善。这些结果不仅验证了 Fabhalta 作为补体因子 B 抑制剂的作用机制，而且还使其成为诺华公司指出的具有良好安全性特征的首创口服疗法。至关重要的是，该药物的耐受性（与之前的试验结果一致）降低了治疗中断的风险，而治疗中断是慢性病管理中常见的难题。这与整个行业向以患者为中心的疗法转变的趋势相符，这种疗法优先考虑患者的依从性和生活质量。对于诺华公司而言，这些优势转化为持久的竞争优势，尤其是在Fabhalta扩展到C3G领域之后，该药物获批成为首个可用于治疗C3G疾病的药物。据PR Newswire分析，IgAN市场在2024年的价值为7.3亿美元，预计到2034年将以30.5%的复合年增长率(CAGR)增长，这主要得益于Fabhalta等靶向疗法的推出。据该PR Newswire报道，到2034年，该市场规模可能超过38.7亿美元。其中，诺华的药物有望占据相当大的市场份额。Fabhalta 进军 C3G 领域进一步扩大了这一增长，据 pharmaphorum 报道，它是目前唯一获得 FDA 批准的 C3G 治疗药物。此外，正如诺华所指出的，Fabhalta 还拥有针对非典型溶血性尿毒综合征 (aHUS) 和狼疮性肾炎的研发管线。更广泛的罕见病治疗领域，预计到2024年价值将达到2200亿美元。预计到2032年，该市场规模将飙升至4550亿美元，年复合增长率达9.5%。生物制剂、基因疗法和人工智能驱动的药物再利用领域的创新正在加速罕见病药物的研发。行业报道还重点提及了诺华公司专注于口服制剂的战略——这使其区别于Alexion公司的Soliris和Apellis公司的Empaveli等注射剂竞争对手。竞争格局：应对挑战与机遇尽管Fabhalta面临着来自Calliditas公司的Tarpeyo和Travere公司的Filspari等新兴疗法的竞争（ScienceDirect综述中对此进行了讨论），但其先发优势和可靠的临床数据使其拥有显著优势。该药物的孤儿药资格认定和监管激励措施，包括EMA授予的针对C3G的PRIME资格（据PR Newswire报道），也简化了其全球获批的路径。然而，挑战依然存在，包括高价疗法的价格压力和报销障碍。诺华能否达成有利的准入协议——尤其是在北美，根据 Global Growth Insights 的数据，北美在 IgAN 市场占据主导地位，市场份额为 36% 至 44.8%——对于最大限度地发挥 Fabhalta 的收入潜力至关重要。 Fabhalta的成功体现了诺华公司向高利润、创新驱动型罕见病疗法的战略转型。据PR Newswire报道，该药预计峰值销售额将达到30亿美元，并且诺华公司还拥有一系列互补的在研产品（例如，用于治疗IgA肾病的atrasentan和zigakibart），使其成为公司肾脏疾病产品组合的基石。对于投资者而言，主要风险包括传统FDA审批流程的延迟以及生物类似药或新一代补体抑制剂的上市。然而，该药独特的特性，加上该领域的结构性增长动力，使其成为一项极具吸引力的长期投资。总之，诺华的Fabhalta不仅是临床创新的成果，更是即将迎来指数级增长的罕见病治疗领域的一项战略资产。随着罕见病治疗市场的不断发展，Fabhalta兼具临床价值和财务回报的能力，有望巩固诺华在这个高风险领域的领先地位。 2026 年 7 月 16 日，美国食品药品监督管理局 (FDA) 已批准 Fabhalta® （ iptacopan，伊普可泮）用于延缓有疾病进展风险的原发性免疫球蛋白 A 肾病 (IgAN) 成年患者的肾功能下降：

2026-08-16

·国际糖尿病idiabetes

从MRA到ASI：邹长虹教授解析醛固酮-MR通路药物在CKM中的循证进展

编者按心血管、肾脏与代谢异常相互影响，使心血管-肾脏-代谢综合征（CKM）的风险不断累积。醛固酮分泌异常及盐皮质激素受体（MR）过度激活贯穿高血压、慢性肾脏病（CKD）和心力衰竭等多种临床表型，并可推动炎症、纤维化及靶器官损伤。随着盐皮质激素受体拮抗剂（MRA）的证据从射血分数降低的心衰和2型糖尿病相关CKD，延伸至左心室射血分数≥40%的心衰及非糖尿病CKD，醛固酮合成酶抑制剂（ASI）也在未控制和难治性高血压中显示出降压作用。2026年肥胖大会期间，中国医学科学院阜外医院邹长虹教授围绕作用机制、关键研究与适用人群，梳理了醛固酮-MR通路药物在CKM管理中的循证进展。从醛固酮生成到MR激活：两类药物靶向通路的不同环节醛固酮主要由肾上腺皮质球状带合成，其分泌受血管紧张素Ⅱ、血钾水平和促肾上腺皮质激素等因素调节[1]。生理状态下，醛固酮通过促进肾脏钠重吸收和钾排泄，参与维持血容量与血压稳态；分泌异常增多时，则可引起水钠潴留和低钾血症，并通过炎症、氧化应激和纤维化等过程促进心脏、血管与肾脏损伤[1,2]。其作用既包括MR介导的基因组效应，也包括快速非基因组信号；后者可涉及G蛋白偶联雌激素受体等通路[2]。针对该通路的药物主要分为MRA和ASI。螺内酯与依普利酮属于甾体类MRA，非奈利酮为非甾体类MRA；三者在受体选择性、组织分布、药代动力学和不良反应谱方面存在差异[3]。MRA通过阻断MR抑制下游信号，临床证据主要来自高血压、CKD和心衰领域。ASI则选择性抑制由CYP11B2编码的醛固酮合成酶，减少醛固酮生成，从而同时影响醛固酮介导的基因组与非基因组效应；Baxdrostat和Lorundrostat已在未控制或难治性高血压人群中完成Ⅲ期研究[2]。循证证据持续扩展：从血压控制走向心肾结局美国心脏协会2023年主席咨询报告、2026年AHA/ACC/ADA/ASN指南及中国专家共识将CKM描述为代谢危险因素、CKD与心血管疾病相互作用的系统性健康障碍，并按照风险和疾病进展划分为0～4期，共5个阶段[4-6]。从危险因素聚集、亚临床病变到临床心血管疾病，CKM呈连续进展。醛固酮-MR通路贯穿高血压、CKD和心衰等多种CKM表型，其药物证据需要结合疾病阶段、研究人群与结局类型加以理解。难治性高血压：螺内酯确立第四线地位，ASI拓展降压路径难治性高血压（RH）通常指在足量或最大耐受剂量下联合使用3种不同机制的降压药物——一般包括肾素-血管紧张素系统（RAS）抑制剂、长效钙通道阻滞剂和利尿剂——血压仍未达标，或需要≥4种药物才能控制血压。PATHWAY-2采用随机、双盲、交叉设计，在标准治疗基础上比较螺内酯、比索洛尔、多沙唑嗪与安慰剂。螺内酯使家庭收缩压较安慰剂进一步降低8.70 mmHg，较比索洛尔和多沙唑嗪分别进一步降低4.48 mmHg和4.03 mmHg（P均<0.001），支持将其作为符合条件RH患者的第四线用药[7]（图1）。图1 PATHWAY-2研究结果 ASI的Ⅲ期证据主要来自BaxHTN与Launch-HTN研究。BaxHTN纳入未控制或难治性高血压患者，Baxdrostat 2 mg/d和1 mg/d治疗12周后，收缩压较安慰剂分别进一步降低9.8 mmHg和8.7 mmHg（P均<0.001）[8]。Launch-HTN纳入1083例正在使用2～5种降压药物的患者；Lorundrostat 50 mg/d使自动诊室收缩压在第6周较安慰剂进一步降低9.1 mmHg，第12周差值为11.6 mmHg（P均<0.001）[9]（图2）。两项研究共同提示，抑制醛固酮合成可在既有降压方案基础上进一步降低血压。图2 Launch-HTN研究结果慢性肾脏病：非奈利酮证据由T2DM相关CKD延伸至更广泛病因 1. 2型糖尿病相关CKD：在接受最大耐受剂量RAS抑制剂治疗的2型糖尿病（T2DM）相关CKD患者中，FIDELIO-DKD显示，非奈利酮使主要肾脏复合终点风险降低18%，并使关键次要心血管复合终点风险降低14%[10]。FIGARO-DKD则以心血管复合终点为主要终点，非奈利酮使该终点风险降低13%（HR=0.87，95% CI：0.76～0.98）；首个次要肾脏复合终点的HR为0.87（95% CI：0.76～1.01）[11]。 FIDELITY汇总FIDELIO-DKD与FIGARO-DKD的13026例受试者，显示非奈利酮使心血管复合终点和肾脏复合终点风险分别降低14%和23%[12]。CONFIDENCE进一步评估非奈利酮与SGLT2抑制剂的联合策略：第180天时，非奈利酮联合恩格列净使尿白蛋白/肌酐比值（UACR）的降幅，较非奈利酮单药和恩格列净单药分别扩大29%和32%（P均<0.001）[13]。 2. 1型糖尿病相关CKD：FINE-ONE纳入242例1型糖尿病（T1DM）相关CKD患者。治疗6个月后，非奈利酮组UACR较基线降低34%，安慰剂组降低12%；组间几何均值比为0.75（95% CI：0.65～0.87，P<0.001）[14]，将非奈利酮的研究人群拓展至T1DM相关CKD。 3. 非糖尿病CKD及更广泛CKD人群：FIND-CKD纳入非糖尿病、蛋白尿性CKD患者。随访32个月时，非奈利酮组与安慰剂组eGFR总斜率分别为-3.3和-4.0 mL/min/1.73 m2/年，组间差值为0.7 mL/min/1.73 m2/年（95% CI：0.3～1.1，P<0.001）；肾脏或心血管复合终点的HR为0.77（95% CI：0.60～0.99，P=0.04）[15]。 INFINITY对14574例伴或不伴T2DM的CKD患者进行个体数据汇总分析，非奈利酮使肾衰竭或eGFR持续下降≥57%的风险降低24%，心衰住院或心血管死亡风险降低20%，全因死亡风险降低12%[16]。与此同时，BARACK-D和ALCHEMIST分别在3b期CKD和慢性血液透析人群中，未显示螺内酯可降低各自设定的心血管主要终点[17,18]。急性心肌梗死：获益取决于是否合并左室功能受损或心衰在未合并心衰或显著左室收缩功能障碍的急性心肌梗死（AMI）人群中，早期加用MRA对临床结局的证据并不一致。ALBATROSS未显示早期MRA改善主要临床结局；REMINDER中，依普利酮降低了由心血管死亡、再住院或住院时间延长以及利钠肽升高构成的复合终点，但差异主要由利钠肽变化驱动[19,20]。心力衰竭：从HFrEF的经典证据到LVEF≥40%的新进展 1. 射血分数降低的心衰（HFrEF）：RALES显示，螺内酯使重度HFrEF患者的全因死亡风险降低30%[21]。EPHESUS纳入AMI后左心室射血分数（LVEF）≤40%并伴心衰症状或糖尿病的患者，依普利酮使全因死亡风险降低15%，心脏性猝死风险降低21%[22]。EMPHASIS-HF进一步显示，在症状较轻的收缩性心衰患者中，依普利酮使心血管死亡或心衰住院风险降低37%，全因死亡风险降低24%[23]（图3）。这些研究共同构成甾体类MRA改善HFrEF预后的主要依据。图3 EMPHASIS-HF研究结果 2. 射血分数轻度降低或保留的心衰（HFmrEF/HFpEF）：甾体类MRA在该人群中的结果并不完全一致。Aldo-DHF显示，螺内酯可改善左心室舒张功能，但未改善峰值耗氧量、症状或生活质量[24]。TOPCAT中，螺内酯对心血管死亡、心脏骤停复苏或心衰住院构成的主要复合终点未产生显著影响（HR=0.89，95% CI：0.77～1.04，P=0.14），但心衰住院风险有所降低（HR=0.83，95% CI：0.69～0.99）；后续分析还显示不同研究地区之间存在明显异质性[25,26]。非奈利酮为LVEF≥40%的心衰提供了新的结局证据。FINEARTS-HF显示，非奈利酮使总心衰恶化事件与心血管死亡构成的复合终点发生率降低16%（率比=0.84，95% CI：0.74～0.95，P=0.007）[27]（图4）。FINE-HEART汇总18991例心肾代谢疾病患者，非奈利酮使全因死亡、心衰住院和肾脏复合终点风险分别降低9%、17%和20%[28]。FINALITY-HF、REDEFINE-HF与CONFIRMATION-HF等在研项目，分别聚焦不能使用甾体类MRA的HFrEF、LVEF≥40%的急性失代偿心衰，以及住院心衰患者中非奈利酮联合SGLT2抑制剂等问题[29]。图4 FINEARTS-HF研究结果小结醛固酮-MR通路药物已在不同CKM临床场景中形成层次分明的证据体系。难治性高血压方面，PATHWAY-2支持螺内酯作为第四线用药，ASI的Ⅲ期研究则提供了抑制醛固酮合成的降压路径。CKD方面，非奈利酮证据已从T2DM相关CKD延伸至T1DM相关CKD和非糖尿病、蛋白尿性CKD；BARACK-D与ALCHEMIST的结果也提示，甾体类MRA的证据不能在不同肾脏病人群间直接等同。心衰方面，甾体类MRA可改善HFrEF及AMI后左室功能受损或心衰患者的预后，FINEARTS-HF则补充了LVEF≥40%人群的结局证据。临床选择应回到患者表型、肾功能、血钾水平、合并治疗与目标结局，使药物证据与适宜人群和管理阶段相匹配。专家简介邹长虹教授中国医学科学院阜外医院心血管内科博士、副主任医师中国中药协会心血管药物研究专业委员会第二届专委会青年委员北京健康教育协会心血管病专委会委员《中华心力衰竭和心肌病杂志》责任编辑《中国肥厚型心肌病管理指南2017》、《2020年中国心力衰竭医疗质量控制报告》、《中国肥厚型心肌病指南2022》、《国家心力衰竭指南2023》主要执笔人之一参考文献（上下滑动可查看） [1] Fioretti F, et al. Aldosterone and aldosterone modulation in cardio-kidney diseases. J Am Coll Cardiol. 2025;86(5):354-373. doi:10.1016/j.jacc.2025.06.012. [2] Rossi GP, et al. Aldosterone synthase inhibitors for the treatment of cardiovascular disease. Nat Rev Endocrinol. 2026;22:543-553. doi:10.1038/s41574-026-01259-4. [3] Kim DL, Lee SE. Renal protection of mineralocorticoid receptor antagonist, finerenone, in diabetic kidney disease. Endocrinol Metab (Seoul). 2023;38(1):43-55. doi:10.3803/EnM.2022.1629. [4] Ndumele CE, et al. Cardiovascular-kidney-metabolic health: a presidential advisory from the American Heart Association. Circulation. 2023;148(20):1606-1635. doi:10.1161/CIR.0000000000001184. [5] Writing Committee Members, et al. 2026 AHA/ACC/ADA/ASN guideline for the prevention, detection, evaluation, and management of cardiovascular-kidney-metabolic syndrome. J Am Coll Cardiol. 2026;87(22S):e1889-e2007. doi:10.1016/j.jacc.2026.03.056. [6] 心血管-肾脏-代谢综合征评估、诊断、治疗专家共识. 中华心血管病杂志. 2026;54(7):733-757. [7] Williams B, et al. Spironolactone versus placebo, bisoprolol, and doxazosin to determine the optimal treatment for drug-resistant hypertension (PATHWAY-2): a randomised, double-blind, crossover trial. Lancet. 2015;386(10008):2059-2068. doi:10.1016/S0140-6736(15)00257-3.[8] Flack JM, et al. Efficacy and safety of baxdrostat in uncontrolled and resistant hypertension. N Engl J Med. 2025;393(14):1363-1374. doi:10.1056/NEJMoa2507109.[9] Saxena M, et al. Lorundrostat in participants with uncontrolled hypertension and treatment-resistant hypertension: the Launch-HTN randomized clinical trial. JAMA. 2025;334(5):409-418. doi:10.1001/jama.2025.9413.[10] Bakris GL, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845.[11] Pitt B, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956.[12] Agarwal R, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.[13] Agarwal R, et al. Finerenone with empagliflozin in chronic kidney disease and type 2 diabetes. N Engl J Med. 2025;393(6):533-543. doi:10.1056/NEJMoa2410659.[14] Heerspink HJL, et al. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854.[15] Heerspink HJL, et al. Finerenone in chronic kidney disease without diabetes. N Engl J Med. 2026;395(6):533-545. doi:10.1056/NEJMoa2604625.[16] Neuen BL, et al. Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY). Lancet. 2026;407(10546):2375-2386. doi:10.1016/S0140-6736(26)01009-3.[17] Hobbs FDR, et al. Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial. Nat Med. 2024;30(12):3634-3645. doi:10.1038/s41591-024-03263-5.[18] Rossignol P, et al. Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2025;406(10504):695-704. doi:10.1016/S0140-6736(25)01194-8.[19] Beygui F, et al. Early aldosterone blockade in acute myocardial infarction: the ALBATROSS randomized clinical trial. J Am Coll Cardiol. 2016;67(16):1917-1927. doi:10.1016/j.jacc.2016.02.033.[20] Montalescot G, et al. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind REMINDER Study. Eur Heart J. 2014;35(34):2295-2302. doi:10.1093/eurheartj/ehu164.[21] Pitt B, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999;341(10):709-717. doi:10.1056/NEJM199909023411001.[22] Pitt B, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348(14):1309-1321. doi:10.1056/NEJMoa030207.[23] Zannad F, et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364(1):11-21. doi:10.1056/NEJMoa1009492.[24] Edelmann F, et al. Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial. JAMA. 2013;309(8):781-791. doi:10.1001/jama.2013.905.[25] Pitt B, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014;370(15):1383-1392. doi:10.1056/NEJMoa1313731.[26] Pfeffer MA, et al. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015;131(1):34-42. doi:10.1161/CIRCULATIONAHA.114.013255.[27] Solomon SD, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2024;391(16):1475-1485. doi:10.1056/NEJMoa2407107.[28] Vaduganathan M, et al. Finerenone and cardiovascular, kidney, and mortality outcomes across the spectrum of kidney and heart failure in the FINE-HEART pooled analysis of 3 phase 3 trials. Nat Med. 2024;30(12):3758-3764. doi:10.1038/s41591-024-03264-4.[29] Sauer AJ, Ter Maaten JM, Savarese G. Established and emerging pharmacologic options and unmet needs in HFpEF and HFmrEF. ESC Heart Fail. 2026;13(2):xvag056. doi:10.1093/eschf/xvag056. 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：《心肾代谢时讯》编辑部）

100 项与 Lorundrostat 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12773 D12774	-	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
难治性高血压	申请上市	美国	Mineralys Therapeutics, Inc.	-
阻塞性睡眠呼吸暂停综合征	临床2期	美国	Mineralys Therapeutics, Inc.	2025-02-28
白蛋白尿	临床2期	美国	Mineralys Therapeutics, Inc.	2023-12-14
慢性肾病	临床2期	美国	Mineralys Therapeutics, Inc.	2023-12-14
肾性高血压	临床2期	美国	Mineralys Therapeutics, Inc.	2021-07-01

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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


NCT06150924 (Explore-CKD, CTgov)	临床2期	高血压 \| 慢性肾病 \| 白蛋白尿	60	Placebo (Placebo)	繭艱淵襯獵壓窪醖夢獵(製選憲齋願餘鬱襯顧網) = 憲構顧繭鹹觸艱壓觸夢壓獵構鹹淵憲製繭獵繭 (糧願獵鏇構襯艱觸鏇艱, 積鏇構顧憲網觸憲艱膚 ~ 鑰積衊淵製鑰範糧選窪) 更多	-	2026-06-03
				Lorundrostat (Lorundrostat)	繭艱淵襯獵壓窪醖夢獵(製選憲齋願餘鬱襯顧網) = 窪遞繭齋膚窪構製獵糧壓獵構鹹淵憲製繭獵繭 (糧願獵鏇構襯艱觸鏇艱, 夢顧鑰糧製簾鹽獵製鏇 ~ 糧窪範願範夢鏇糧膚簾) 更多
NCT06150924 (Explore-CKD, GlobeNewswire \| ASN2025) 人工标引	临床2期	高血压 \| 慢性肾病	-	LorundrostatLorundrostat 25mg	憲襯鹽餘憲觸齋膚觸鏇(願願獵淵製簾廠淵選廠) = 遞壓觸鹽觸網淵鹹構廠製簾膚鬱製糧壓鹹醖襯 (窪醖鏇醖製淵獵願膚鬱 ) 达到更多	积极	2025-06-17
				Placebo	憲襯鹽餘憲觸齋膚觸鏇(願願獵淵製簾廠淵選廠) = 範鬱繭積窪鏇窪襯衊夢製簾膚鬱製糧壓鹹醖襯 (窪醖鏇醖製淵獵願膚鬱 ) 达到更多
NCT05769608 (ADVANCE-HTN, Company_Website) 人工标引	临床2期	难治性高血压	-	Lorundrostat 50 mg	製蓋觸窪鹽簾醖鹹鏇顧(簾顧鑰衊觸鑰蓋蓋夢夢) = 願鏇鹹構鏇願簾繭顧衊鹽憲簾膚蓋願廠鑰鏇衊 (鹽遞鬱糧築壓範願鏇鏇 ) 达到更多	积极	2025-03-10
				Lorundrostat 50-100 mg	鬱齋鬱齋鬱鹽鬱餘築廠(簾範簾積鬱糧廠繭遞蓋) = 簾淵鬱簾蓋壓窪觸製齋鹹廠遞齋鑰構廠築齋鹹 (鏇願膚構範築糧願願膚 )
NCT06153693 (Launch-HTN, Company_Website) 人工标引	临床3期	难治性高血压	1,083	Lorundrostat 50 mg	願夢顧醖壓願網構膚糧(簾築壓窪顧壓鏇簾齋網) = 膚製窪壓鹽遞鬱鑰蓋選鹽網淵鬱網壓製艱鏇蓋 (網範餘遞醖夢顧窪網衊 ) 达到更多	积极	2025-03-10
				Lorundrostat 50-100 mg	願夢顧醖壓願網構膚糧(範餘積範糧夢願繭獵築) = 構憲鬱齋遞餘膚鹹顧廠築鬱簾壓廠顧鹹襯糧簾 (憲願構構艱鹹齋顧鏇衊 ) 更多
NCT05001945 (Target-HTN, CTgov)	临床2期	肾性高血压	200	Placebo (Placebo - Part 1)	鏇鏇蓋淵淵積觸壓鹽衊(齋觸壓鹹築鬱窪醖廠積) = 襯簾醖夢蓋繭獵願積繭憲願網壓顧夢夢選廠鏇 (鑰淵膚鑰壓顧艱壓夢鹹, 2.62) 更多	-	2024-01-05
				Lorundrostat (Lorundrostat 12.5 mg BID - Part 1)	鏇鏇蓋淵淵積觸壓鹽衊(齋觸壓鹹築鬱窪醖廠積) = 淵憲製鏇積構壓鑰網觸憲願網壓顧夢夢選廠鏇 (鑰淵膚鑰壓顧艱壓夢鹹, 3.15) 更多
NCT05001945 (Target-HTN, GlobeNewswire) 人工标引	临床2期	高血压	200	lorundrostat	醖選獵範壓襯願製鑰製(鑰夢顧窪遞壓遞觸淵願) = 顧網網簾選夢構鬱顧膚艱廠繭壓網願獵鹽衊鏇 (顧鑰糧遞網繭艱製膚壓 )	积极	2023-11-11
				lorundrostat (50mg)	醖築網鑰蓋簾積顧蓋製(繭夢壓齋廠憲製壓襯鹽) = 壓醖餘鏇艱襯選膚繭糧醖顧顧衊衊鏇範獵鏇簾 (蓋糧淵壓簾壓鏇淵艱廠 )
NCT05001945 (Target-HTN, Pubmed) 人工标引	临床2期	高血压	200	lorundrostat 12.5 mg	鹽醖鹽廠積窪艱衊鬱糧(醖壓蓋鏇積憲襯糧積鑰) = 築網鬱築襯構範窪觸鏇願壓顧鹹繭顧襯繭繭顧 (遞鏇構衊壓醖鑰夢窪繭 )	积极	2023-09-10
				lorundrostat 25 mg	鹽醖鹽廠積窪艱衊鬱糧(醖壓蓋鏇積憲襯糧積鑰) = 簾選鏇繭積鹽選窪淵網願壓顧鹹繭顧襯繭繭顧 (遞鏇構衊壓醖鑰夢窪繭 )