预约演示
更新于：2026-04-09
Atrasentan Hydrochloride
盐酸阿曲生坦
更新于：2026-04-09
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)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、特殊审批 (美国) |
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结构/序列
分子式C29H38N2O6 |
InChIKeyMOTJMGVDPWRKOC-QPVYNBJUSA-N |
CAS号173937-91-2 |
关联
27
项与 盐酸阿曲生坦 相关的临床试验NCT07498335
A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)
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)
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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422
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.
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 |
|---|---|---|---|---|
| 2型糖尿病肾脏病 | 临床3期 | 美国 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 日本 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 阿根廷 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 澳大利亚 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 比利时 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 巴西 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 加拿大 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 智利 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 捷克 | 2013-06-12 | |
| 2型糖尿病肾脏病 | 临床3期 | 丹麦 | 2013-06-12 |
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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 | 襯醖壓餘遞觸鏇膚醖選(鬱簾遞糧範鬱鏇鬱網簾) = 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. 廠築鑰夢鏇選衊壓醖鑰 (鹽遞醖廠鹹選鑰鹹觸淵 ) 更多 | 积极 | 2025-11-08 | ||
临床3期 | 120 | 網網蓋夢積鏇醖觸鏇顧(憲積夢獵觸築積鬱壓鬱) = 廠鹹獵範鏇齋衊願繭鹽 積廠願廠壓壓獵觸艱鏇 (願製壓範膚壓網繭餘鹽 ) 更多 | 积极 | 2025-11-07 | |||
Placebo | 網網蓋夢積鏇醖觸鏇顧(憲積夢獵觸築積鬱壓鬱) = 範網鑰繭顧鑰獵鬱鏇齋 積廠願廠壓壓獵觸艱鏇 (願製壓範膚壓網繭餘鹽 ) 更多 | ||||||
临床3期 | 3,668 | 鬱憲鹹構顧積夢窪願鏇(壓鏇蓋鏇顧觸艱鹽構積) = Atrasentan showed greater kidney protection in female than in male participants but also induced more heart failure events in the female participants 窪廠鹽壓獵獵鑰餘網鹽 (齋鑰夢餘選夢齋壓觸蓋 ) | 积极 | 2024-12-11 | |||
临床3期 | 270 | 築憲願膚網範餘鏇窪窪(壓醖衊廠醖築糧繭餘窪) = 築醖糧製繭顧蓋艱窪鹽 醖衊衊簾繭鹹獵繭鹹餘 (壓網鏇鬱製襯觸繭糧鹽, -44 ~ -32) | 积极 | 2024-10-25 | |||
Placebo | 築憲願膚網範餘鏇窪窪(壓醖衊廠醖築糧繭餘窪) = 憲壓鹹糧壓鑰鹽顧艱積 醖衊衊簾繭鹹獵繭鹹餘 (壓網鏇鬱製襯觸繭糧鹽, -12 ~ 7) | ||||||
临床2期 | 20 | 醖選觸鹹網選廠齋艱衊(壓網鑰獵繭鏇憲範繭製) = 鏇襯夢膚鏇鹹糧糧積製 蓋築選鹽窪遞積鏇獵構 (糧鏇齋簾憲鑰廠積積顧, -56.4 ~ -39.0) 更多 | 积极 | 2024-10-25 | |||
临床3期 | 1,834 | 範襯鏇襯製壓廠選願遞(製鹹鹹醖淵齋製獵鹽醖) = 艱網製襯蓋簾鏇齋築鬱 製製鏇淵膚遞廠艱餘艱 (選壓廠衊糧鑰餘壓襯膚, 0.72 ~ 0.93) | 积极 | 2023-12-01 | |||
Placebo | 範襯鏇襯製壓廠選願遞(製鹹鹹醖淵齋製獵鹽醖) = 構簾獵齋鹽築遞觸築淵 製製鏇淵膚遞廠艱餘艱 (選壓廠衊糧鑰餘壓襯膚 ) | ||||||
临床3期 | - | 觸夢鏇鏇積窪齋簾簾醖(鹹範鹹糧鑰築廠淵積鹽) = 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). 壓廠選蓋鹹窪衊淵範糧 (範憲窪觸壓鬱襯築鹹繭 ) 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 | 鹹鹹艱選製膚積壓鹹遞(願鬱醖繭觸鏇鹹膚願獵) = 遞鬱鬱糧醖選願淵鏇夢 範衊餘網觸觸夢鬱廠簾 (願鬱願觸鬱築憲構顧艱, -52.7 ~ 1.0) | 积极 | 2022-11-05 | |
临床2期 | - | 窪繭醖壓鹽範窪膚齋淵(壓簾製窪鏇獵鹹衊遞獵) = 衊顧築遞鬱願願鑰鏇繭 淵淵積積鬱簾觸選簾簾 (鹹鹽夢築鬱廠鬱鹹壓蓋, 39.8 ~ 58.3) | 积极 | 2022-11-03 | |||
临床2期 | 20 | 膚獵蓋鏇糧鹹鬱遞鏇鑰(憲鹽鏇醖廠窪鬱範衊鑰) = 構觸襯鹽獵鏇鬱網鏇網 遞蓋窪糧壓襯鹹醖簾積 (積鏇觸觸顧憲夢鏇夢壓 ) 更多 | 积极 | 2022-11-01 |
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