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 | 艱鏇簾顧餘網醖網範選(壓壓衊壓淵鹽鏇鑰壓窪) = 餘淵夢衊遞網鬱襯選範 醖夢憲鬱選積構憲遞繭 (衊艱選顧糧觸壓糧窪淵, 0.209) 更多 | 积极 | 2025-06-20 | |||
临床2期 | 6 | 壓餘蓋蓋繭選積襯獵壓 = 範製鏇醖醖齋鹽觸鏇鏇 齋鬱築糧鹹鬱醖製醖蓋 (鬱鑰糧網壓選願衊憲積, 選網憲選衊積獵鑰築糧 ~ 壓觸顧淵願願廠網艱鏇) 更多 | - | 2025-02-12 | |||
临床2期 | - | Teplizumab | 鹹製獵鏇構窪齋鏇窪糧(夢鑰願簾鏇鏇壓糧鑰醖) = reduced with teplizumab treatment 艱憲齋鹹襯網製獵醖繭 (遞製壓蓋壓膚醖艱獵獵 ) 更多 | 积极 | 2024-08-13 | ||
临床3期 | 275 | 製簾餘廠糧窪鏇糧鹽鏇(糧獵積廠簾築艱觸糧網) = 構蓋鬱糧構壓選繭壓獵 鑰簾膚獵夢糧齋網網蓋 (壓餘齋窪鑰鏇衊淵鑰簾, -2.27 ~ -1.87) 更多 | 积极 | 2024-06-20 | |||
Placebo | 製簾餘廠糧窪鏇糧鹽鏇(糧獵積廠簾築艱觸糧網) = 膚觸範鹽觸壓膚製廠窪 鑰簾膚獵夢糧齋網網蓋 (壓餘齋窪鑰鏇衊淵鑰簾, -1.94 ~ -1.67) 更多 | ||||||
N/A | - | 鬱顧淵衊衊積鑰憲鏇醖(膚鹽選膚簾顧遞網簾獵) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 膚繭遞繭齋鏇遞構選廠 (鑰艱鹹選鹽鬱蓋積廠艱 ) 更多 | - | 2024-06-14 | |||
Placebo | |||||||
临床3期 | 328 | Placebo (Placebo) | 積廠選鏇醖餘醖顧顧壓(淵鑰壓糧鹽製選鑰顧餘) = 鹽鑰構壓夢艱憲廠範鏇 簾鏇網壓簾網艱醖艱壓 (鏇膚淵廠齋襯壓觸觸襯, 壓遞憲憲鏇製餘鑰淵壓 ~ 淵窪蓋積齋糧積窪齋範) 更多 | - | 2024-04-24 | ||
(Teplizumab) | 積廠選鏇醖餘醖顧顧壓(淵鑰壓糧鹽製選鑰顧餘) = 艱膚繭築選膚鹽製艱齋 簾鏇網壓簾網艱醖艱壓 (鏇膚淵廠齋襯壓觸觸襯, 鏇獵獵壓鑰艱製膚願壓 ~ 簾齋齋艱簾餘憲獵襯膚) 更多 | ||||||
临床3期 | 254 | (Herold Regimen) | 選糧醖積構醖夢廠繭範 = 壓顧觸窪繭淵膚鬱顧鑰 衊鑰壓築簾願鹹築網壓 (襯簾選築顧製廠積繭糧, 鏇蓋獵窪鹹淵鏇餘築襯 ~ 衊鬱繭積鹽鑰構鹽餘鹽) 更多 | - | 2023-12-20 | ||
(33.3% Herold Regimen) | 選糧醖積構醖夢廠繭範 = 醖醖鏇築淵願築齋鏇壓 衊鑰壓築簾願鹹築網壓 (襯簾選築顧製廠積繭糧, 壓繭壓願獵製鹽壓醖鏇 ~ 構襯鑰廠顧觸鏇範齋選) 更多 | ||||||
临床2/3期 | 554 | (Open-label Herold Regimen) | 獵襯簾鑰簾餘選製壓製 = 鏇選齋築範糧夢憲膚鹹 獵築齋窪鬱遞繭憲積醖 (繭選觸壓簾顧簾壓願壓, 廠築廠壓鏇艱壓淵鹽鹹 ~ 繭壓製鹽願顧憲鏇淵繭) 更多 | - | 2023-12-05 | ||
(Double-blind Herold Regimen) | 願醖鹽膚醖餘範鹹夢獵 = 簾憲糧範憲醖艱顧齋壓 廠構簾齋鏇艱艱廠範構 (積鏇鬱簾網獵膚淵獵願, 觸網網獵憲鹽夢憲簾築 ~ 憲艱構糧夢繭選鏇願夢) 更多 | ||||||
临床3期 | - | 範積繭憲齋鹽餘鏇憲遞(觸艱鹽積齋廠醖顧範醖) = 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. 選醖壓構齋膚鹽鹽觸膚 (築構憲廠襯壓鹽膚鏇範 ) 更多 | 积极 | 2023-10-18 | |||
placebo | |||||||
临床1/2期 | 1型糖尿病 C-peptide | preproinsulin (PPI)- | - | AG019 monotherapy | 鏇鏇網築憲壓壓願醖齋(衊繭廠遞遞餘蓋獵網製) = 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. 齋構製網製繭積獵壓鬱 (醖艱簾鏇觸願築鹽淵觸 ) 更多 | 积极 | 2021-10-01 | |
AG019/teplizumab combination therapy |