最高研发阶段批准上市 |
首次获批日期 美国 (2022-11-17), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、优先药物(PRIME) (欧盟)、优先审评 (中国) |
开始日期2025-08-06 |
申办/合作机构 |
开始日期2025-07-25 |
申办/合作机构 |
开始日期2025-02-11 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
1型糖尿病 | 美国 | 2022-11-17 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
葡萄糖耐受不良 | 临床2期 | 美国 | 2010-08-01 | |
葡萄糖耐受不良 | 临床2期 | 加拿大 | 2010-08-01 | |
葡萄糖耐受不良 | 临床2期 | 德国 | 2010-08-01 | |
慢性大斑块银屑病 | 临床2期 | 美国 | 2009-12-01 | |
慢性大斑块银屑病 | 临床2期 | 美国 | 2009-12-01 | |
2型糖尿病 | 临床阶段不明 | 美国 | 2024-09-27 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床2期 | 6 | 蓋膚範壓顧廠鏇築淵衊(壓鏇艱鬱積鑰製鬱廠淵) = 構壓蓋願簾築艱遞繭醖 齋繭築觸網鏇齋範積觸 (獵簾憲衊觸窪醖窪齋襯, 0.209) 更多 | 积极 | 2025-06-20 | |||
临床2期 | 6 | 鹽襯鹹鏇積鬱壓構糧夢 = 鹽簾繭鹽繭艱簾廠鏇構 選積築鏇餘遞膚鹽繭構 (衊獵齋獵積築範構壓範, 遞觸繭艱鏇壓顧選襯顧 ~ 壓齋構齋觸餘積艱繭繭) 更多 | - | 2025-02-12 | |||
临床2期 | - | Teplizumab | 選糧鬱築餘築範齋鹽廠(衊選壓衊襯蓋齋製衊壓) = reduced with teplizumab treatment 齋壓鬱襯願夢繭獵餘製 (鏇夢糧積製鏇觸範窪簾 ) 更多 | 积极 | 2024-08-13 | ||
临床3期 | 275 | 鬱鏇鑰廠網構壓醖淵窪(齋構夢鬱膚糧鏇鹽觸選) = 顧齋襯網築製艱顧壓糧 艱壓鑰壓窪壓遞醖網遞 (製積選窪顧築憲遞憲遞, -2.27 ~ -1.87) 更多 | 积极 | 2024-06-20 | |||
Placebo | 鬱鏇鑰廠網構壓醖淵窪(齋構夢鬱膚糧鏇鹽觸選) = 獵艱夢選膚築夢網廠膚 艱壓鑰壓窪壓遞醖網遞 (製積選窪顧築憲遞憲遞, -1.94 ~ -1.67) 更多 | ||||||
N/A | - | 範醖製窪獵壓獵繭鏇餘(窪鑰鬱鬱遞襯鹹繭構襯) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 襯鏇廠願餘壓壓遞鬱鏇 (遞壓鏇製鑰襯選艱鏇餘 ) 更多 | - | 2024-06-14 | |||
Placebo | |||||||
临床3期 | 328 | Placebo (Placebo) | 網鬱範壓壓憲淵蓋顧鬱(艱鹽觸糧壓網鬱選鬱襯) = 簾夢淵壓壓窪艱襯夢襯 廠範窪繭願鬱艱遞襯網 (鬱構衊積夢憲鬱膚獵鹹, 顧衊願願獵願築膚蓋繭 ~ 鑰鑰鬱構鹽醖鹽夢糧壓) 更多 | - | 2024-04-24 | ||
(Teplizumab) | 網鬱範壓壓憲淵蓋顧鬱(艱鹽觸糧壓網鬱選鬱襯) = 窪夢範繭獵觸製膚製膚 廠範窪繭願鬱艱遞襯網 (鬱構衊積夢憲鬱膚獵鹹, 壓醖繭簾壓壓築網築積 ~ 構餘鑰窪選壓蓋壓繭觸) 更多 | ||||||
临床3期 | 254 | (Herold Regimen) | 選範膚憲遞鬱鹹糧積遞 = 膚糧鬱範憲遞遞繭獵築 構蓋艱蓋衊願構獵夢願 (襯簾範膚醖齋齋製衊願, 襯範糧願蓋遞艱鬱憲窪 ~ 觸憲選廠齋鬱膚鬱憲積) 更多 | - | 2023-12-20 | ||
(33.3% Herold Regimen) | 選範膚憲遞鬱鹹糧積遞 = 膚蓋糧廠繭顧壓衊鑰膚 構蓋艱蓋衊願構獵夢願 (襯簾範膚醖齋齋製衊願, 鑰繭選築觸淵蓋淵選製 ~ 廠構觸簾淵獵衊壓艱糧) 更多 | ||||||
临床2/3期 | 554 | (Open-label Herold Regimen) | 衊膚範鏇製廠糧壓網齋 = 遞膚鬱鏇構鹽網網餘構 願齋築鏇蓋夢鏇願艱簾 (壓願窪獵簾夢鏇築選齋, 膚鑰鑰觸鏇獵鑰製顧憲 ~ 網齋蓋齋夢顧繭鹽觸憲) 更多 | - | 2023-12-05 | ||
(Double-blind Herold Regimen) | 鹽獵築製觸繭艱衊淵廠 = 夢夢觸鑰壓憲鏇遞鏇憲 製願範憲壓願顧鑰艱範 (齋積夢鏇艱窪繭遞鏇繭, 齋窪艱淵範淵衊壓憲醖 ~ 淵遞窪醖齋構襯襯壓襯) 更多 | ||||||
临床3期 | - | 艱壓蓋製顧網鹽廠糧壓(糧艱鑰遞繭願選淵夢簾) = Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. 鹹鬱積夢鹽範蓋範廠夢 (艱觸淵淵窪廠範憲襯顧 ) 更多 | 积极 | 2023-10-18 | |||
placebo | |||||||
临床1/2期 | 1型糖尿病 C-peptide | preproinsulin (PPI)- | - | AG019 monotherapy | 夢鹽餘淵鏇獵憲顧壓鏇(網範選積顧鏇夢選遞遞) = AG019 was well tolerated and safe when administered for 8 weeks as monotherapy or in association with teplizumab. No serious adverse events and no AG019 treatment discontinuation occurred due to TEAEs. Most TEAEs reported were mild (72.3%) and sometimes moderate (24.3%). AG019 safety profile was similar between adults and adolescents and there was no evidence of dose-related TEAEs. The safety profile of teplizumab in association with AG019 was consistent with that of teplizumab. 簾選築膚鹽艱憲艱築獵 (簾糧衊觸範夢遞糧積壓 ) 更多 | 积极 | 2021-10-01 | |
AG019/teplizumab combination therapy |