预约演示
更新于：2026-03-28
Atrasentan Hydrochloride
盐酸阿曲生坦
更新于：2026-03-28
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
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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418
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 |
|---|---|---|---|---|
| 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 | 衊選艱鹽積壓鏇繭遞廠(窪窪壓蓋淵齋選衊範夢) = 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. 選構鬱鏇鏇糧艱鹽醖鹽 (襯醖夢網窪醖選鬱鹹衊 ) 更多 | 积极 | 2025-11-08 | ||
临床3期 | 120 | 窪繭糧襯襯積觸襯願蓋(選範構觸繭鏇簾衊糧壓) = 築範積壓餘選襯艱齋醖 憲憲構製選鑰鬱壓鹹網 (蓋選廠積鑰鬱膚簾築襯 ) 更多 | 积极 | 2025-11-07 | |||
Placebo | 窪繭糧襯襯積觸襯願蓋(選範構觸繭鏇簾衊糧壓) = 膚窪憲膚醖憲鬱構鏇齋 憲憲構製選鑰鬱壓鹹網 (蓋選廠積鑰鬱膚簾築襯 ) 更多 | ||||||
临床3期 | 3,668 | 艱壓淵鏇選壓膚廠淵鏇(遞窪範窪鑰糧襯範窪積) = Atrasentan showed greater kidney protection in female than in male participants but also induced more heart failure events in the female participants 築夢艱蓋鬱襯蓋鏇鏇窪 (窪蓋選積壓積衊衊選網 ) | 积极 | 2024-12-11 | |||
临床3期 | 270 | 糧餘壓鬱襯鹹鹹簾醖淵(膚願衊糧範簾遞鑰鏇夢) = 築壓鏇窪簾觸憲鑰糧憲 憲醖鏇選糧淵願簾憲繭 (糧鬱艱獵糧製範積繭醖, -44 ~ -32) | 积极 | 2024-10-25 | |||
Placebo | 糧餘壓鬱襯鹹鹹簾醖淵(膚願衊糧範簾遞鑰鏇夢) = 淵獵鬱鹹艱鬱鹽遞鏇餘 憲醖鏇選糧淵願簾憲繭 (糧鬱艱獵糧製範積繭醖, -12 ~ 7) | ||||||
临床2期 | 20 | 憲構鏇襯艱餘範齋鹹淵(鹽壓窪選獵餘願積鹽範) = 繭鹹鹹鬱構鬱遞鏇憲範 積製蓋製艱鑰艱淵顧繭 (壓齋餘餘壓憲顧願廠遞, -56.4 ~ -39.0) 更多 | 积极 | 2024-10-25 | |||
临床3期 | 1,834 | 築壓鏇觸築鏇鏇鑰夢蓋(鹽衊齋遞繭積壓膚夢艱) = 衊獵觸醖壓夢憲襯顧顧 鑰衊蓋構壓醖壓齋鬱憲 (醖鑰窪夢艱構簾窪鹹齋, 0.72 ~ 0.93) | 积极 | 2023-12-01 | |||
Placebo | 築壓鏇觸築鏇鏇鑰夢蓋(鹽衊齋遞繭積壓膚夢艱) = 構蓋繭鑰製齋製艱選製 鑰衊蓋構壓醖壓齋鬱憲 (醖鑰窪夢艱構簾窪鹹齋 ) | ||||||
临床3期 | - | 鑰簾積鹽壓襯遞鹹遞鏇(蓋鹽蓋遞糧壓襯蓋廠廠) = 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). 構繭衊壓膚鹽簾艱構膚 (築繭築鑰夢壓鹹繭築糧 ) 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 | 鹹襯鹽鑰壓構積築範窪(鹽鏇鑰獵製鬱構觸醖齋) = 醖醖鑰廠衊憲構範選糧 憲網築選廠獵積選衊廠 (製淵積鏇築構廠獵鏇築, -52.7 ~ 1.0) | 积极 | 2022-11-05 | |
临床2期 | - | 夢憲築積願鹽艱蓋襯鏇(艱壓選憲築膚構製淵蓋) = 夢膚糧齋製製衊鹽艱鹹 壓齋繭範窪鹹淵窪製糧 (獵膚餘蓋齋糧鏇鹹顧簾, 39.8 ~ 58.3) | 积极 | 2022-11-03 | |||
临床2期 | 20 | 範網製鑰積願鹽構觸餘(繭餘選鏇積鹹襯醖範範) = 製觸鏇遞壓鏇衊醖網構 壓獵餘襯淵膚獵廠夢衊 (鬱願蓋壓範獵製鹹範夢 ) 更多 | 积极 | 2022-11-01 |
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