替利珠单抗(Teplizumab) - 药物靶点：CD3_在研适应症：1型糖尿病，2型糖尿病_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

hOKT3-gamma-1-ala-ala、hOKT3-γ1-ala-ala、Teplizumab (USAN/INN)

+ [9]

靶点

CD3

作用方式

抑制剂

作用机制

CD3抑制剂(T细胞表面糖蛋白CD3复合体抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sanofi Winthrop Industrie SA

+ [3]

非在研机构

MacroGenics, Inc.

Eli Lilly & Co.

Yale University

+ [1]

权益机构

Eli Lilly & Co.

Provention Bio, Inc.

Sanofi

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2022-11-17),

1型糖尿病

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)、孤儿药 (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

26

项与替利珠单抗相关的临床试验

NCT07360080

/ RecruitingN/A

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

开始日期2026-03-19

申办/合作机构

Sanofi

NCT07457580

/ RecruitingN/A

A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.

开始日期2026-03-16

申办/合作机构

Sanofi

NCT07260110

/ RecruitingN/A

TEPLIzumab: QUality of Life Evaluation During Stage Transition

This study is an observational, longitudinal, non-interventional real-world study in the United States. The study is meant to describe the experience of participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab and the experience of participants with stage 2 type 1 diabetes who have not been infused with teplizumab, and to compare descriptively the experiences of the two groups.
Primary Objective:
- To characterize health related quality of life, diabetes-related anxiety, diabetes-related burden, and ease of diabetes management, and how participants feel, form and function in those who infused and those who did not infuse with teplizumab
Secondary Objectives:
* To show the clinical transitions experienced by those who infused and those who did not infuse with teplizumab
* To describe the prevalence and timing of diabetes misclassification and the temporal patterns between misclassification, antibody testing, and the correct diagnosis of type 1 diabetes in those who infused and those who did not infuse with teplizumab
* To estimate the impact of diagnostic misclassification on the timing of progression to stage 3 type 1 diabetes in those who infused and those who did not infuse with teplizumab
* To characterize glucose monitoring strategies in those who infused and those who did not infuse with teplizumab where possible
* To characterize insulin use in those who infused and those who did not infuse with teplizumab where possible
* To characterize longitudinal health care resource utilization in those who infused and those who did not infuse with teplizumab

开始日期2025-10-31

申办/合作机构

Sanofi

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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641

项与替利珠单抗相关的文献（医药）

2026-05-01·DIABETOLOGIA

Teplizumab treatment for stage 2 type 1 diabetes: a real-world evaluation of metabolic and immunological outcomes

Article

作者: Steck, Andrea K ; Karakus, Kagan E ; Triolo, Taylor M ; Michels, Aaron W ; Chesshir, Lexie ; Frohnert, Brigitte I ; Baschal, Erin E ; McDaniel, Kristen A ; Simmons, Kimber M ; Gottlieb, Peter A ; Walker, Sonya

AIMS/HYPOTHESIS:

This is the first real-world prospective observational study of teplizumab use following approval by the United States Food and Drug Administration in individuals with stage 2 type 1 diabetes. We examined whether glycaemic responses observed in controlled trials were reproduced in real-world practice and explored immunological biomarkers associated with treatment.

METHODS:

Children and adults with stage 2 type 1 diabetes were prospectively followed in the Early Type 1 Diabetes Clinic at the Barbara Davis Center. Individuals who received teplizumab between April 2023 and February 2025 (n=30) were compared with an untreated group (n=10). Key assessments included OGTTs, HbA_1c measurements and continuous glucose monitoring (CGM) data, collected before and after treatment. Longitudinal metabolic data were available for up to 22 treated participants, with follow-up assessments occurring between 2 and 13 months after treatment. Changes in Epstein-Barr virus (EBV) and islet antigen-targeting T cell receptor (TCR) β chains were measured longitudinally from genomic DNA via a PCR-based targeted TCR sequencing assay.

RESULTS:

Among treated individuals followed up between 2 and 6 months after treatment, OGTT 2 h glucose improved (10.7 ± 2.1 to 8.8 ± 2.8 mmol/l, p=0.007), as did HbA_1c (40 ± 4 to 39 ± 6 mmol/mol [5.8 ± 0.4% to 5.7 ± 0.5%], p=0.044). In addition, 67% had a stable or reduced CGM time ≥7.8 mmol/l. CD4 preproinsulin-specific TCRs declined after treatment, with no change in the untreated group. These reductions correlated with higher C-peptide AUC (r=-0.656, p=0.013). EBV TCR sequences were similar before and after teplizumab treatment.

CONCLUSIONS/INTERPRETATION:

Teplizumab can be safely and effectively administered in clinical practice. Early glycaemic improvements and reductions in CD4 preproinsulin-specific TCRs suggest that post-treatment immunological changes may serve as biomarkers to guide early-stage intervention.

2026-04-01·Cold Spring Harbor Perspectives in Medicine

Clinical Immunologic Interventions for the Treatment of Type 1 Diabetes: Challenges, Choice, and Timing of Immunomodulators

Review

作者: Tatovic, Danijela ; Dayan, Colin

Replacement insulin therapy has been the mainstay of type 1 diabetes mellitus (T1D) treatment ever since its introduction into clinical care more than 100 years ago. Despite advances in delivery methods, insulin remains a challenging medication. It is, therefore, not surprising that most people with T1D do not achieve optimal glycemic control and remain at risk of complications. The recent introduction of teplizumab as the first immunotherapy for T1D has ushered in an exciting era where the focus is shifted from metabolic replacement therapy with insulin to proactive disease-modifying treatments that prevent the loss of insulin secretory capacity. At least nine other clinical immunologic interventions have shown phase 2 trial efficacy in preserving β-cell function in T1D. To translate these findings to patient benefit, many changes are required. These include improvements in end points and trial design to accelerate drug development, changing the attitude of healthcare professionals toward novel strategies, and the development of effective screening programs to identify affected individuals in early-stage disease. This will enable a broad portfolio of β-cell preserving therapies to be approved, in turn allowing appropriate selection of immunomodulators tailored to an individual's response with an ultimate goal of "insulin-free T1D."

2026-03-01·Biotechnology 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.

461

项与替利珠单抗相关的新闻（医药）

2026-04-28

·药研苑

山东威高宝龄富锦合作降磷药物枸橼酸铁胶囊获批上市

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年4月27日国家药品监督管理局（NMPA）网站信息显示，山东威高与宝龄富锦生技合资公司山东威高宝龄制药的枸橼酸铁胶囊已获批上市。预计获批的适应症为：用于慢性肾病透析患者高磷血症。枸橼酸铁（Ferric Citrate）为铁基-非钙磷结合剂。枸橼酸铁所含的3价铁离子在胃肠道能够与磷酸盐反应，形成不溶于水的磷酸铁沉淀，随粪便排出体外，从而降低磷的吸收率，降低血清磷酸盐浓度。此外枸橼酸铁的3价铁离子，能够被胃肠道中的三价铁还原酶还原为二价铁离子，被人体吸收利用，改善慢性肾脏病患者的缺铁性贫血。与蔗糖羟基氧化铁相比，枸橼酸铁对铁摄取的影响更高（Jürgen Floege., 2020）。目前FDA已经批准枸橼酸铁用于治疗慢性肾脏病透析患者的高磷血症，以及慢性肾脏病非透析患者的缺铁性贫血。高磷血症是慢性肾病患者常见的并发症。由于含钙的磷结合剂能够增加高钙血症、血管钙化和心血管事件的发生风险，因此治疗慢性肾病患者高磷血症国内主要使用不含钙的磷结合剂，包括蔗糖羟基氧化铁（Sucroferric Oxyhydroxide）、司维拉姆（Sevelamer）和碳酸镧（Lanthanum Carbonate）。 2025年台湾企业宝龄富锦生技宣布与山东威高成立合资公司，向中国大陆引起宝龄富锦生技的降磷药物枸橼酸铁胶囊（Nephoxil）。推荐指数：★★ 推荐原因：高磷血症是慢性肾病患者的常见并发症。而目前国内治疗高磷血症的产品种类有限，市场进入相对容易。相关阅读： FDA批准赛诺菲替利珠单抗预防1型糖尿病适用年龄降至1岁口服司美格鲁肽儿童/青少年2型糖尿病3期试验取得积极结果阿斯利康曲麦利尤单抗获批联合度伐利尤单抗用于晚期肝癌康哲长效IL-4Rα单抗柯美奇拜申请上市用于季节性过敏性鼻炎康辰药业慢性盆腔痛1类新药筋骨草总环烯醚萜苷片申请上市金赛药业GS1-144用于更年期潮热2期临床试验研究结果发表常州制药申请首仿第二代JAK抑制剂阿布昔替尼片辰光医药CG2001泡沫剂用于男性脱发2期试验达到主要终点和黄医药索乐匹尼申请上市用于温抗体型自身免疫性溶血性贫血翰森食欲素-2受体拮抗剂HS-10506失眠1b/2期试验数据发布石药HB1901晚期血管周围上皮样细胞瘤1b /3期研究达到终点葛兰素史克玛贝兰妥单抗获批治疗二线及以上多发性骨髓瘤诺和诺德Etavopivat镰状细胞病3期临床试验达到双终点南光原研引进，阿地溴铵福莫特罗吸入粉雾剂获批上市康方生物发布卡度尼利单抗一线用于晚期胰腺癌2期试验数据相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-04-28

·药研苑

首仿，华阳制药第二代JAK抑制剂乌帕替尼缓释片获批

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年4月27日华阳制药宣布，其乌帕替尼缓释片已获得国家药品监督管理局批准上市。华阳制药乌帕替尼缓释片是国内首家获批的乌帕替尼缓释片仿制药品。乌帕替尼（Upadacitinib）属于选择性JAK1（Janus激酶1）抑制剂，原研企业为艾伯维AbbVie。乌帕替尼通过抑制JAK1K-STAT信号通路发挥抗炎作用。其对于JAK1的选择性远高于JAK2，因此能够避免非选择性JAK抑制剂抑制JAK2产生的不良反应。乌帕替尼（瑞福RINVOQ）已在国内获批的适应症包括：特应性皮炎、类风湿关节炎、银屑病关节炎、溃疡性结肠炎、克罗恩病、放射学阴性中轴型脊柱关节炎、强直性脊柱炎和巨细胞动脉炎。 JAK-STAT信号通路参与到炎症因子引起的生物效应，因此抑制JAK激活可有效抑制炎症反应。JAK家族共有4个成员，JAK1、JAK2、JAK3和TYK2。由于JAK广泛参与多种细胞因子的生物效应，因此非选择JAK抑制剂可能带来多种不良反应。第一代JAK抑制剂为非选择性JAK抑制剂，第二代JAK抑制剂为选择性JAK抑制剂，不良反应相对更少。其中选择性JAK3/TYK2抑制剂，由于涉及的细胞因子较少，也被归为第三代JAK抑制剂。目前已获批的第二代JAK包括乌帕替尼（Upadacitinib）、阿布昔替尼（Abrocitinib）、戈利昔替尼（Golidocitinib）和艾玛昔替尼（Ivarmacitinib）。推荐指数：★ 推荐原因：乌帕替尼在国内市场增长良好，华阳制药乌帕替尼缓释片首仿获批有利于占据市场先机，取得有利的市场地位。相关阅读： FDA批准赛诺菲替利珠单抗预防1型糖尿病适用年龄降至1岁口服司美格鲁肽儿童/青少年2型糖尿病3期试验取得积极结果阿斯利康曲麦利尤单抗获批联合度伐利尤单抗用于晚期肝癌康哲长效IL-4Rα单抗柯美奇拜申请上市用于季节性过敏性鼻炎康辰药业慢性盆腔痛1类新药筋骨草总环烯醚萜苷片申请上市金赛药业GS1-144用于更年期潮热2期临床试验研究结果发表常州制药申请首仿第二代JAK抑制剂阿布昔替尼片辰光医药CG2001泡沫剂用于男性脱发2期试验达到主要终点和黄医药索乐匹尼申请上市用于温抗体型自身免疫性溶血性贫血翰森食欲素-2受体拮抗剂HS-10506失眠1b/2期试验数据发布石药HB1901晚期血管周围上皮样细胞瘤1b /3期研究达到终点葛兰素史克玛贝兰妥单抗获批治疗二线及以上多发性骨髓瘤诺和诺德Etavopivat镰状细胞病3期临床试验达到双终点南光原研引进，阿地溴铵福莫特罗吸入粉雾剂获批上市康方生物发布卡度尼利单抗一线用于晚期胰腺癌2期试验数据相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-04-28

·药研苑

独家剂型，和泽医药甲苯磺酸艾多沙班口崩片获批上市

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年4月27日国家药品监督管理局网站信息显示，和泽医药下属和晨药业的甲苯磺酸艾多沙班口崩片已经获批上市。艾多沙班（Edoxaban）为新型口服抗凝药（NOAC），属于选择性可逆转凝血因子Ⅹa抑制剂。凝血因子Ⅹa抑制剂由于不易发生药物相互作用，已成为一线口服抗凝药物。目前国内获批上市凝血因子Ⅹa抑制剂包括利伐沙班（Rivaroxaban）、阿哌沙班（Apixaban）和艾多沙班（Edoxaban）。艾多沙班与利伐沙班相比，消化道出血风险相对较小（Xiuehui Chen., 2023）。与阿哌沙班相比，艾多沙班只需1天给药一次。艾多沙班的原研企业为第一三共，第一三共甲苯磺酸艾多沙班片（里先安®LIXIANA®）已在国内获批的适合症包括：用于伴有一个或多个风险因素（如充血性心力衰竭、高血压、年龄≥75 岁、糖尿病、既往卒中或短暂性脑缺血发作（TIA）病史）的非瓣膜性房颤（NVAF）成人患者，预防卒中和体循环栓塞；以及用于治疗成人深静脉血栓（DVT）和肺栓塞（PE），以及预防成人深静脉血栓和肺栓塞复发。口崩片是一种在口腔内不需要用水，即能迅速崩解或溶解的片剂。由于无需用水，迅速崩解，与普通片剂相比，口崩片更适合用于吞咽困难的患者使用。此外，也适合用在一些需要紧急使用、强制使用等特殊的使用场景。推荐指数：☆ 推荐原因：口崩片主要适合吞咽困难，以及紧急使用、强制使用的患者，与普通口服制剂相比，口崩往往价值较高，并且口味不佳。在抗凝领域，真正需要口崩片使用的场合相对较少。相关阅读： FDA批准赛诺菲替利珠单抗预防1型糖尿病适用年龄降至1岁口服司美格鲁肽儿童/青少年2型糖尿病3期试验取得积极结果阿斯利康曲麦利尤单抗获批联合度伐利尤单抗用于晚期肝癌康哲长效IL-4Rα单抗柯美奇拜申请上市用于季节性过敏性鼻炎康辰药业慢性盆腔痛1类新药筋骨草总环烯醚萜苷片申请上市金赛药业GS1-144用于更年期潮热2期临床试验研究结果发表常州制药申请首仿第二代JAK抑制剂阿布昔替尼片辰光医药CG2001泡沫剂用于男性脱发2期试验达到主要终点和黄医药索乐匹尼申请上市用于温抗体型自身免疫性溶血性贫血翰森食欲素-2受体拮抗剂HS-10506失眠1b/2期试验数据发布石药HB1901晚期血管周围上皮样细胞瘤1b /3期研究达到终点葛兰素史克玛贝兰妥单抗获批治疗二线及以上多发性骨髓瘤诺和诺德Etavopivat镰状细胞病3期临床试验达到双终点南光原研引进，阿地溴铵福莫特罗吸入粉雾剂获批上市康方生物发布卡度尼利单抗一线用于晚期胰腺癌2期试验数据相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

100 项与替利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09013	替利珠单抗	-	DB06606

研发状态

批准上市

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适应症	国家/地区	公司	日期
1型糖尿病	美国	Provention Bio, Inc.	2022-11-17

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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	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	加拿大	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	临床2期	德国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
慢性大斑块银屑病	临床2期	美国	MacroGenics, Inc.	2009-12-01
慢性大斑块银屑病	临床2期	美国	Eli Lilly & Co.	2009-12-01
银屑病	临床2期	美国	MacroGenics, Inc.	2009-12-01
银屑病	临床2期	美国	Eli Lilly & Co.	2009-12-01
2型糖尿病	临床阶段不明	美国	Sanofi	2024-09-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05757713 (PETITE-T1D, Pubmed \| Diabetologia)	临床2期	1型糖尿病	23	Teplizumab	夢憲艱餘積夢鬱艱繭鏇(製窪鬱鹽獵襯膚襯夢餘) = 窪齋願鹹鑰觸鬱鹽鹽窪鏇遞窪遞糧餘觸廠選窪 (壓糧糧鹹襯積鏇餘壓廠 ) 更多	积极	2025-11-06
TN-10 Extension (ADA2025)	临床2期	1型糖尿病	6	Teplizumab	蓋齋衊糧鹹窪選積醖壓(醖鹽鏇齋蓋醖範鹽衊醖) = 積構鏇齋鹽齋積鏇繭顧製膚觸網襯醖廠憲遞觸 (窪淵鑰齋襯築範齋觸憲, 0.209) 更多	积极	2025-06-20
NCT04270942 (CTgov)	临床2期	1型糖尿病	6	Teplizumab	獵鹹顧網網糧糧鬱衊餘 = 顧築獵壓簾積鹽鏇艱製夢製選淵夢獵願網網製 (繭醖廠蓋構獵選夢廠願, 鬱繭廠簾餘簾糧網觸窪 ~ 糧選觸餘積範鹹願鑰獵) 更多	-	2025-02-12
NCT01030861 (Pubmed \| J Clin Invest)	临床2期	1型糖尿病	-	Teplizumab	顧餘憲鏇遞積夢製製鑰(繭遞繭醖鏇夢製製糧壓) = reduced with teplizumab treatment 衊夢觸窪齋鬱構繭簾築 (構齋膚觸顧鹽簾夢網膚 ) 更多	积极	2024-08-13
NCT03875729 (PROTECT, ADA2024) 人工标引	临床3期	1型糖尿病	275	Teplizumab	構鬱蓋願憲淵積網鹽範(糧鏇鏇衊鬱製壓鹹壓觸) = 鑰鑰鹹糧觸壓構窪鏇範網網選網鏇壓餘網積簾 (窪鏇醖鏇齋網壓願顧糧, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	構鬱蓋願憲淵積網鹽範(糧鏇鏇衊鬱製壓鹹壓觸) = 築繭鹹壓襯憲淵夢醖糧網網選網鏇壓餘網積簾 (窪鏇醖鏇齋網壓願顧糧, -1.94 ~ -1.67) 更多
ADA2024	N/A	1型糖尿病	-	Teplizumab	襯獵壓鏇鬱襯艱壓壓衊(願構觸糧艱鹽鏇鏇窪願) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 憲憲遞積蓋願膚夢積繭 (膚鏇鬱鏇襯壓積鬱窪願 ) 更多	-	2024-06-14
				Placebo
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	襯觸憲簾範鬱膚範蓋鹽(膚憲顧鹽遞觸餘醖艱鹹) = 鬱遞構遞衊膚積鹽襯艱憲鑰鹽選艱壓觸遞鹽醖 (餘遞顧憲醖夢壓廠糧餘, 遞遞夢積繭顧製衊餘觸 ~ 鬱鏇襯餘繭襯簾願憲窪) 更多	-	2024-04-24
				teplizumab (Teplizumab)	襯觸憲簾範鬱膚範蓋鹽(膚憲顧鹽遞觸餘醖艱鹹) = 鏇願願醖醖鹹夢糧餘選憲鑰鹽選艱壓觸遞鹽醖 (餘遞顧憲醖夢壓廠糧餘, 壓鏇淵膚衊積繭廠繭範 ~ 觸網淵淵遞構壓製鹽鏇) 更多
NCT00920582 (CTgov)	临床3期	1型糖尿病	254	Teplizumab Herold Regimen (Herold Regimen)	構窪簾衊艱艱鹹簾衊糧 = 壓醖糧鑰構艱構築鹽憲壓窪淵鑰鑰憲醖蓋鏇蓋 (獵簾獵艱鹽糧壓淵獵簾, 積淵膚蓋繭顧繭選襯範 ~ 蓋壓餘選選窪鹹築簾繭) 更多	-	2023-12-20
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	構窪簾衊艱艱鹹簾衊糧 = 鹹觸蓋蓋醖衊簾願網艱壓窪淵鑰鑰憲醖蓋鏇蓋 (獵簾獵艱鹽糧壓淵獵簾, 膚淵構窪鹹醖醖遞膚醖 ~ 獵膚衊繭鹽淵淵鏇壓範) 更多
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	願窪築顧範壓繭獵築餘 = 願鹹衊壓獵糧齋築襯鹹製選憲積壓艱製餘衊鹽 (齋顧繭膚繭糧壓願繭艱, 獵觸憲鬱齋網獵襯窪製 ~ 鬱鹽膚齋壓遞齋醖築構) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	觸餘蓋遞網繭積廠鑰鑰 = 衊繭餘積製顧鬱獵醖淵艱鏇構艱網積簾夢遞鬱 (膚鹽餘選淵願糧齋齋醖, 範鹽選餘願餘鑰蓋獵積 ~ 淵襯築鹹窪遞鬱蓋願糧) 更多
NCT03875729 (PROTECT, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	1型糖尿病	-	Teplizumab	衊鏇鬱範糧獵蓋夢遞網(糧膚襯願蓋鹹築膚獵遞) = 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. 憲築襯鏇積膚簾艱鹹構 (夢憲選衊鬱獵願憲醖鏇 ) 更多	积极	2023-10-18
				placebo