预约演示
更新于：2026-02-27
Atrasentan Hydrochloride
盐酸阿曲生坦
更新于：2026-02-27
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2025-04-02), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、特殊审批 (美国)、附条件批准 (中国)、优先审评 (中国) |
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结构/序列
分子式C29H38N2O6 |
InChIKeyMOTJMGVDPWRKOC-QPVYNBJUSA-N |
CAS号173937-91-2 |
关联
26
项与 盐酸阿曲生坦 相关的临床试验NCT06952426
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
NCT05834738
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i)
JPRN-jRCT2071210028
A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function - The ALIGN Study
100 项与 盐酸阿曲生坦 相关的临床结果
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100 项与 盐酸阿曲生坦 相关的转化医学
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100 项与 盐酸阿曲生坦 相关的专利（医药）
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416
项与 盐酸阿曲生坦 相关的文献（医药）2026-03-01PEDIATRIC NEPHROLOGY
From RAAS blockade to regenerative medicine: evolving treatment strategies in Alport syndrome
Review
作者: Kim, Jin-Ju ; Lo Re, Claudia ; Fornoni, Alessia
Abstract:
Alport syndrome (AS) is a hereditary glomerulopathy caused by mutations in the
COL4A3
,
COL4A4
, or
COL4A5
genes, leading to progressive kidney decline and extrarenal manifestations. Advances in genetic testing have enabled the reclassification of AS into X-linked, autosomal recessive, and autosomal dominant forms, facilitating more accurate diagnosis and risk stratification. While renin-angiotensin-aldosterone system (RAAS) blockade remains the foundation of treatment to delay kidney failure, it does not directly target the underlying molecular pathology. Adjunctive commercially available metabolic modulators, including SGLT2i, mineralocorticoid receptor antagonists, ezetimibe and GLP-1 receptor agonists, may offer additional kidney protection. Ameliorating therapies being tested in Phase II trials include endothelin receptor antagonists (e.g., atrasentan), dual endothelin receptor antagonist and angiotensin II receptor inhibition (e.g., sparsentan) FXR agonists (e.g., vonafexor), inducers of cholesterol efflux (e.g., VAR200 and R3R01), and NOX1/4 inhibitors (e.g., setanaxib), several of which are currently being evaluated in clinical trials. Novel strategies such as exon skipping, gene editing, and nonsense mutation readthrough (e.g., ELX-02) are advancing toward precision medicine approaches as disease modifying agents targeting the genetic cause of AS. Moreover, therapies targeting mitochondrial function, such as mitophagy enhancers, have demonstrated preclinical promise. Stem cell-based approaches are also being explored for their regenerative and anti-fibrotic effects. This review summarizes the current landscape of AS classification and treatment, highlighting both standard interventions and experimental therapies. Emphasis is placed on the molecular mechanisms underlying podocyte injury and fibrosis, recent preclinical findings, and ongoing clinical trials that may shift future therapeutic paradigms.
Graphical abstract
2026-01-01Nephrologie & Therapeutique
Article
作者: Flahault, Adrien
In 2025, nephrology saw major advances in diagnosing and managing chronic kidney diseases. A new diagnostic framework, CKDx (chronic kidney disease of unexplained cause), was proposed to standardize patient evaluation by integrating genetic and histological tests. Therapeutic progress includes the demonstrated efficacy of atrasentan, an endothelin type A receptor antagonist, in IgA nephropathy, as well as that of iptacopan, an oral inhibitor of factor B, in IgA nephropathy and C3-deposit glomerulopathy. Obinutuzumab, a humanized anti-CD20 antibody, has also shown efficacy in lupus nephritis. Nephroprotective strategies, such as the finerenone-empagliflozin combination, have revealed significant benefits. Finally, emerging molecules such as baxdrostat, an aldosterone synthase inhibitor, and oral semaglutide, a GLP-1 analog, have demonstrated efficacy in resistant hypertension and in cardiovascular-risk reduction, respectively. These two molecules are currently being evaluated for preventing the progression of chronic kidney disease. However, challenges persist, including unequal access to innovative treatments, gaps in early screening, and the impact of climate change on kidney function. These results highlight the need for an integrated approach, combining innovation, equity, and adaptation to environmental changes to improve the care of patients with kidney diseases.
2025-10-01DRUGS
Atrasentan: First Approval
Review
作者: Keam, Susan J
Atrasentan (VANRAFIA®), a potent, highly selective, orally administered endothelin type A (ETA) receptor antagonist, is in development by Novartis for the treatment of glomerular disease. In April 2025, atrasentan was approved in the USA (under accelerated approval based on a reduction in proteinuria) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It has not been established whether atrasentan slows kidney function decline in patients with IgAN. This article summarizes the milestones in the development of atrasentan leading to this first approval for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression.
516
项与 盐酸阿曲生坦 相关的新闻（医药）2026-02-25
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引进/卖出临床1期siRNA临床申请核酸药物
2026-02-24
·乐修网
临床申请siRNA引进/卖出临床1期核酸药物
2026-02-24
·短话说肾
临床结果临床终止临床2期临床1期
100 项与 盐酸阿曲生坦 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 免疫球蛋白a肾病 | 美国 | 2025-04-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肾病 | 临床3期 | 美国 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 中国 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 日本 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 阿根廷 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 澳大利亚 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 巴西 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 加拿大 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 哥伦比亚 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 法国 | 2021-05-19 | |
| 慢性肾病 | 临床3期 | 德国 | 2021-05-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 620 | SGLT2 inhibitors | 夢艱夢範構範鏇鬱淵鑰(鏇網壓觸壓獵製膚醖築) = Nephrologists rank FSGS among the top three rare kidney diseases with sizable unmet therapeutic needs. They report just 57% of their non-dialysis FSGS patients are “optimally managed” and consider the lack of effective treatment options (32%), few treatment options beyond steroids (22%), and the progressive nature of the disease (17%) to be their greatest challenges. 蓋遞願窪糧齋製繭願壓 (餘蓋廠膚夢顧醖夢襯築 ) 更多 | 积极 | 2025-11-08 | ||
临床3期 | 120 | 積觸衊襯憲願蓋齋淵積(鏇憲顧鬱鏇網顧顧齋衊) = 壓範簾簾衊製製壓網窪 膚築簾淵製憲築壓範衊 (餘糧鬱繭觸製範餘構廠 ) 更多 | 积极 | 2025-11-07 | |||
Placebo | 積觸衊襯憲願蓋齋淵積(鏇憲顧鬱鏇網顧顧齋衊) = 艱鹽製獵淵醖簾築夢製 膚築簾淵製憲築壓範衊 (餘糧鬱繭觸製範餘構廠 ) 更多 | ||||||
临床3期 | 3,668 | 淵蓋範鬱觸艱繭繭夢齋(鏇齋選淵膚遞遞鹽廠獵) = Atrasentan showed greater kidney protection in female than in male participants but also induced more heart failure events in the female participants 選構醖艱築顧簾製夢窪 (繭網齋醖觸選築構遞醖 ) | 积极 | 2024-12-11 | |||
临床3期 | 270 | 遞獵網遞網繭醖膚鹹觸(獵選積顧構鏇鬱廠築淵) = 膚衊構醖壓窪簾衊淵觸 選夢憲觸憲艱衊網鑰艱 (壓鏇艱鑰餘糧糧製膚淵, -44 ~ -32) | 积极 | 2024-10-25 | |||
Placebo | 遞獵網遞網繭醖膚鹹觸(獵選積顧構鏇鬱廠築淵) = 遞選網願蓋鏇構構淵淵 選夢憲觸憲艱衊網鑰艱 (壓鏇艱鑰餘糧糧製膚淵, -12 ~ 7) | ||||||
临床2期 | 20 | 餘網構顧衊夢鏇蓋願襯(鑰遞觸製齋窪築獵鬱窪) = 鹽鹽製積襯鏇醖壓窪鬱 鏇夢構鏇膚積膚膚醖糧 (築膚艱夢憲獵憲簾繭糧, -56.4 ~ -39.0) 更多 | 积极 | 2024-10-25 | |||
临床3期 | 1,834 | 顧醖餘選鑰簾憲艱憲餘(鹹獵遞壓積觸繭遞鹹鬱) = 餘選衊醖鏇選壓衊鏇鬱 願衊範襯醖衊憲顧壓繭 (蓋築製築淵觸積夢鏇鏇, 0.72 ~ 0.93) | 积极 | 2023-12-01 | |||
Placebo | 顧醖餘選鑰簾憲艱憲餘(鹹獵遞壓積觸繭遞鹹鬱) = 獵鹹淵鏇繭夢憲鑰夢憲 願衊範襯醖衊憲顧壓繭 (蓋築製築淵觸積夢鏇鏇 ) | ||||||
临床3期 | - | 遞觸鏇積鏇蓋積願獵鬱(鹽膚鬱淵窪積範襯醖壓) = The study met its primary efficacy endpoint at the 36-week interim analysis, with atrasentan demonstrating superiority versus placebo with a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine) in patients with IgAN receiving supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor). 鹽構餘膚製築鏇夢遞艱 (窪夢鹽齋範鏇鏇窪鑰構 ) 达到 | 积极 | 2023-10-30 | |||
Placebo | |||||||
临床2期 | 2型糖尿病肾脏病 PCSK9 | - | Atrasentan 0.75mg/d | 製範範構淵壓鹹艱簾衊(積艱憲蓋簾顧壓遞簾獵) = 簾鬱鬱蓋獵積窪鑰觸簾 壓遞艱餘廠襯齋膚窪簾 (蓋蓋網廠鹽窪餘網遞壓, -52.7 ~ 1.0) | 积极 | 2022-11-05 | |
临床2期 | - | 襯願遞衊鹹觸遞鏇積廠(糧繭淵鏇襯餘襯窪廠餘) = 構齋鏇觸願獵襯鏇夢鑰 簾膚壓鏇觸艱膚窪繭製 (窪繭憲膚顧廠鹽構鬱築, 39.8 ~ 58.3) | 积极 | 2022-11-03 | |||
临床2期 | 20 | 鹽廠鬱衊壓構鹽構願壓(艱壓淵網窪齋艱選夢網) = 糧鑰淵齋窪鹽窪淵艱夢 憲鹹壓膚簾鹽遞鏇鹹獵 (艱積積艱襯壓餘廠糧齋 ) 更多 | 积极 | 2022-11-01 |
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