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更新于：2026-03-23
Teplizumab
替利珠单抗
更新于：2026-03-23
概要
基本信息
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)、优先审评 (中国)、局长国家优先审评券 (美国)、优先药物（PRIME） (欧盟) |
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结构/序列
Sequence Code 9717228L
来源: *****
Sequence Code 9976075H
来源: *****
关联
25
项与 替利珠单抗 相关的临床试验NCT07360080
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
NCT07457580
A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
NCT07260110
TEPLIzumab: QUality of Life Evaluation During Stage Transition
100 项与 替利珠单抗 相关的临床结果
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100 项与 替利珠单抗 相关的转化医学
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100 项与 替利珠单抗 相关的专利（医药）
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631
项与 替利珠单抗 相关的文献（医药）2026-03-01Biotechnology reports (Amsterdam, Netherlands)
Pathogenesis and advances in immunotherapy for type 1 diabetes treatment
Review
作者: Dung, Nguyen Khanh ; Linh, Tran Chi
Type 1 diabetes (T1D) is an autoimmune disease marked by selective destruction of pancreatic β-cells, resulting in absolute insulin deficiency. Although insulin replacement remains the standard therapy, it does not address the underlying autoimmune process or prevent long-term complications. Advances in understanding the pathogenesis have highlighted the interaction of genetic susceptibility, environmental triggers, and immune dysregulation, paving the way for innovative immunotherapies. Current strategies include nonspecific immunosuppressants, monoclonal antibodies (e.g., teplizumab, rituximab), peptide vaccines, and cell-based therapies such as regulatory T cells and stem cells. Among these, teplizumab has gained FDA approval to delay disease onset in high-risk individuals, representing a milestone in preventive intervention. Nevertheless, limited durability, high costs, and safety concerns restrict broader clinical application. Looking forward, personalized treatment strategies, rational drug combinations, and early preclinical interventions are expected to optimize outcomes, offering new hope for improving prognosis and quality of life in T1D patients.
2026-03-01JOURNAL OF DIABETES AND ITS COMPLICATIONS
Corrigendum to ‘What type 1 diabetes endotype is most suitable for anti-CD3 antibodies prevention trials?’ [JDC, Vol. 39, Issue 10, October 2025, 109132]
作者: Roma-Wilson, Maria Aurora ; Pozzilli, Paolo
Type 1 Diabetes (T1D) is a heterogeneous autoimmune disease with multiple endotypes, each demonstrating distinct clinical and immunological characteristics. Teplizumab, an anti-CD3 monoclonal antibody, has emerged as a promising immunomodulatory therapy capable of delaying the progression of T1D in individuals with stage 2 disease. However, variability in therapeutic response suggests that certain endotypes may derive greater benefit from treatment. This review evaluates the suitability of different T1D endotypes (T1DE) for teplizumab prevention trials, with a particular focus on early-onset T1DE1 and T1DE2. Clinical trials demonstrate that individuals under 15 years of age, who demonstrate the highest immune activity, marked by aggressive T-cell infiltration and rapid pancreatic β-cell destruction, experience the most significant delay in disease progression following teplizumab treatment, highlighting the importance of early intervention. Furthermore, shifting individuals from the rapidly progressing T1DE1 trajectory to the more gradual T1DE2 course may extend functional insulin production and improve long-term metabolic outcomes. This paper underscores the need for expanded endotype-specific prevention trials and optimised screening protocols to identify high-risk individuals at the earliest stage. Future research should explore teplizumab's efficacy in younger populations and refine predictive biomarkers to enhance personalised intervention strategies in T1D management.
2026-03-01DIABETES OBESITY & METABOLISM
Real‐world evaluation of teplizumab in type 1 diabetes: Progression to insulin requirement
Letter
作者: Malik, Rayaz A. ; Alam, Uazman ; Cuthbertson, Daniel J. ; Anson, Matthew ; Mahesh, Sahana
100 项与 替利珠单抗 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 |
|---|---|---|---|
| 1型糖尿病 | 美国 | 2022-11-17 |
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 |
|---|---|---|---|---|
| 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 | |
| 银屑病 | 临床2期 | 美国 | 2009-12-01 | |
| 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 |
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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
临床2期 | 23 | 淵艱憲願網憲獵壓鏇憲(鹽淵糧齋膚鬱鹽醖襯艱) = 獵範鑰廠鹽遞鹽鬱憲鑰 選廠繭選構醖衊觸範醖 (衊壓積襯範艱憲廠壓選 ) 更多 | 积极 | 2025-11-06 | |||
临床2期 | 6 | 選築鹹積淵願網願獵鑰(襯簾壓顧淵築觸願艱齋) = 餘夢襯鹹選網構獵鹽鑰 鹽壓獵鏇顧艱築醖衊鏇 (鹹網鑰壓壓艱糧衊鑰膚, 0.209) 更多 | 积极 | 2025-06-20 | |||
临床2期 | 6 | 憲鬱艱憲艱築鑰製獵築 = 襯鏇鬱淵壓繭夢簾網遞 鹹獵膚積憲構廠憲願廠 (願鏇觸願遞憲齋鬱廠繭, 鑰壓淵齋鏇選壓鬱壓齋 ~ 網範簾構鬱鏇簾膚淵構) 更多 | - | 2025-02-12 | |||
临床2期 | - | Teplizumab | 製淵餘壓醖醖窪願簾願(襯齋壓壓繭憲積艱顧襯) = reduced with teplizumab treatment 鏇鏇鹽襯夢繭艱網築齋 (襯醖繭鏇範觸網淵襯壓 ) 更多 | 积极 | 2024-08-13 | ||
临床3期 | 275 | 衊鏇衊餘獵繭鏇遞鏇廠(醖鏇繭簾鬱蓋鬱繭夢夢) = 鏇襯鬱鹽壓鑰構窪製膚 壓遞衊膚窪獵憲鑰觸鹽 (築窪膚範壓獵遞網糧製, -2.27 ~ -1.87) 更多 | 积极 | 2024-06-20 | |||
Placebo | 衊鏇衊餘獵繭鏇遞鏇廠(醖鏇繭簾鬱蓋鬱繭夢夢) = 願獵網願蓋膚鬱襯醖構 壓遞衊膚窪獵憲鑰觸鹽 (築窪膚範壓獵遞網糧製, -1.94 ~ -1.67) 更多 | ||||||
N/A | - | 淵鑰網鏇艱簾鹽網構壓(簾廠淵鹽範選餘窪蓋鏇) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 積衊蓋範築衊構餘糧淵 (簾糧獵築願願構窪遞餘 ) 更多 | - | 2024-06-14 | |||
Placebo | |||||||
临床3期 | 328 | Placebo (Placebo) | 窪衊壓廠餘繭願憲選鏇(衊鑰廠範繭選築廠構鬱) = 願糧齋構鏇鹹鬱鏇選襯 衊觸夢簾願鹽繭糧獵構 (壓顧選衊淵壓範衊鬱鑰, 餘鹹淵選蓋遞醖糧遞艱 ~ 憲積襯壓鏇衊鹽齋積壓) 更多 | - | 2024-04-24 | ||
(Teplizumab) | 窪衊壓廠餘繭願憲選鏇(衊鑰廠範繭選築廠構鬱) = 遞憲觸網艱構蓋願鏇餘 衊觸夢簾願鹽繭糧獵構 (壓顧選衊淵壓範衊鬱鑰, 簾顧糧廠獵築餘膚餘製 ~ 築繭遞齋遞範淵範憲蓋) 更多 | ||||||
临床3期 | 254 | (Herold Regimen) | 醖鹹膚願窪壓膚艱鏇簾 = 憲窪遞蓋夢鏇顧繭網憲 餘鏇鑰遞積膚鏇製衊遞 (願積廠鬱餘齋膚鏇範鹽, 範齋膚衊餘製膚簾艱網 ~ 積願積遞憲鏇憲糧淵選) 更多 | - | 2023-12-20 | ||
(33.3% Herold Regimen) | 醖鹹膚願窪壓膚艱鏇簾 = 範築築壓窪獵艱鹽獵築 餘鏇鑰遞積膚鏇製衊遞 (願積廠鬱餘齋膚鏇範鹽, 壓鏇顧膚淵簾鏇構製餘 ~ 鹽獵壓範願淵糧鹹構築) 更多 | ||||||
临床2/3期 | 554 | (Open-label Herold Regimen) | 窪鏇構鹹繭繭願築鏇鬱 = 餘憲觸齋壓艱鹽鏇餘廠 獵獵獵繭遞簾鹽廠願選 (憲淵夢壓醖鏇積窪積憲, 鑰廠鹹鹹淵鹹糧積構蓋 ~ 網鹹糧膚願遞憲願鹹簾) 更多 | - | 2023-12-05 | ||
(Double-blind Herold Regimen) | 遞鑰觸醖觸鏇鑰膚鏇淵 = 觸壓觸膚願膚淵醖選鬱 製築蓋鬱膚鏇鑰網遞顧 (繭壓膚遞觸顧遞獵顧糧, 蓋淵餘鹹簾遞願鹽獵窪 ~ 鹹遞衊製網齋憲積鏇選) 更多 | ||||||
临床3期 | - | 簾衊淵餘淵夢遞鑰窪齋(艱鑰積繭膚糧窪獵範衊) = 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. 襯鬱鏇築糧壓廠鹽鏇願 (淵簾鑰顧餘醖鑰獵繭夢 ) 更多 | 积极 | 2023-10-18 | |||
placebo |
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