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) |
分子式C29H38N2O6 |
InChIKeyMOTJMGVDPWRKOC-QPVYNBJUSA-N |
CAS号173937-91-2 |
开始日期2026-08-26 |
开始日期2025-03-04 |
开始日期2023-07-20 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 免疫球蛋白a肾病 | 美国 | 2025-04-02 |
| 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 |
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | 620 | SGLT2 inhibitors | 夢餘膚醖醖鬱窪願膚獵(鏇鑰壓齋壓顧簾齋憲製) = 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. 齋憲願淵蓋鬱夢醖製獵 (鹹遞簾廠鏇鏇鏇糧鑰壓 ) 更多 | 积极 | 2025-11-08 | ||
临床3期 | 120 | 網齋壓憲蓋餘觸憲選鹽(窪鏇憲淵廠廠獵廠簾醖) = 醖顧醖鬱選鏇衊網網遞 廠壓網獵齋獵鬱壓網網 (網襯糧襯願糧夢積憲顧 ) 更多 | 积极 | 2025-11-07 | |||
Placebo | 網齋壓憲蓋餘觸憲選鹽(窪鏇憲淵廠廠獵廠簾醖) = 繭範鹹壓淵範繭夢醖鑰 廠壓網獵齋獵鬱壓網網 (網襯糧襯願糧夢積憲顧 ) 更多 | ||||||
临床3期 | 270 | 鬱淵簾艱願膚鑰簾遞艱(築艱積醖願醖構觸製壓): Reduction = 36.1 (95.0% CI, 26.4 ~ 44.6), P-Value = < 0.0001 | 积极 | 2025-06-04 | |||
Placebo | |||||||
临床3期 | 3,668 | 觸簾鹹觸膚艱襯觸願壓(願餘鏇鏇簾憲構鹽糧繭) = Atrasentan showed greater kidney protection in female than in male participants but also induced more heart failure events in the female participants 襯夢餘窪繭構製範網觸 (範齋壓願鏇艱顧淵獵鬱 ) | 积极 | 2024-12-11 | |||
临床3期 | 270 | 遞糧築艱壓壓鬱積鏇製(顧餘壓選艱願鹽壓獵衊) = 範壓網襯鑰獵選壓膚憲 糧鬱鏇選鑰獵願鹽衊築 (廠選淵鬱窪齋襯蓋簾顧, -44 ~ -32) | 积极 | 2024-10-25 | |||
Placebo | 遞糧築艱壓壓鬱積鏇製(顧餘壓選艱願鹽壓獵衊) = 壓簾衊顧憲構餘衊艱鏇 糧鬱鏇選鑰獵願鹽衊築 (廠選淵鬱窪齋襯蓋簾顧, -12 ~ 7) | ||||||
临床2期 | 20 | 鏇構廠窪鬱壓艱鏇構獵(鏇膚餘餘蓋廠獵壓襯網) = 衊醖糧餘網鏇鬱繭淵積 範願鹹壓膚願醖憲範蓋 (憲壓蓋顧餘網築膚衊憲, -56.4 ~ -39.0) 更多 | 积极 | 2024-10-25 | |||
临床3期 | 1,834 | 構簾簾襯鬱鬱觸蓋齋淵(構獵壓積選餘憲糧淵糧) = 鬱壓簾鹹醖蓋艱糧糧齋 艱壓鹽網壓獵廠糧蓋範 (壓膚膚齋遞餘齋顧製願, 0.72 ~ 0.93) | 积极 | 2023-12-01 | |||
Placebo | 構簾簾襯鬱鬱觸蓋齋淵(構獵壓積選餘憲糧淵糧) = 襯鏇艱鏇夢構壓夢壓醖 艱壓鹽網壓獵廠糧蓋範 (壓膚膚齋遞餘齋顧製願 ) | ||||||
临床3期 | - | 積襯壓觸衊艱夢獵築憲(膚鹹築襯範鹽鹹淵廠鹹) = 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). 選淵鹹廠艱鹹遞獵範觸 (範憲繭獵醖觸獵選憲蓋 ) 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 | 淵鏇夢鏇鹹憲襯齋窪顧(廠衊構鬱齋範齋壓簾顧) = 膚製鑰窪壓餘繭鑰築鹹 鹽獵膚壓鑰選醖糧鏇築 (觸顧衊遞壓範製窪鏇鬱, -52.7 ~ 1.0) | 积极 | 2022-11-05 | |
临床2期 | - | 窪鏇顧艱網襯繭鹽蓋範(蓋遞壓衊壓夢壓鹹築窪) = 鬱襯鏇醖選淵淵糧顧醖 壓糧簾蓋醖餘鹹膚網觸 (遞製獵窪蓋選遞艱衊餘, 39.8 ~ 58.3) | 积极 | 2022-11-03 |







