Teplizumab(Teplizumab) - 药物靶点：CD3_在研适应症：1型糖尿病，非胰岛素依赖型糖尿病1_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)

+ [7]

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

Ajinomoto Althea, Inc.

+ [2]

非在研机构

National Institute of Diabetes & Digestive & Kidney Diseases

MacroGenics, Inc.

Eli Lilly & Co.

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)申请上市

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)

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结构/序列

Sequence Code 9717228L

来源: *****

Sequence Code 9976075H

来源: *****

关联

24

项与 Teplizumab 相关的临床试验

NCT06791291

/ Recruiting临床2期

Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 8 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.
Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 8 to 34 years.

开始日期2025-04-30

申办/合作机构

Sanofi

NCT06892002

/ RecruitingN/A

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

开始日期2025-02-11

申办/合作机构

Sanofi

NCT06481904

/ RecruitingN/A

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.
TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

开始日期2024-09-27

申办/合作机构

Sanofi

100 项与 Teplizumab 相关的临床结果

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100 项与 Teplizumab 相关的转化医学

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100 项与 Teplizumab 相关的专利（医药）

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597

项与 Teplizumab 相关的文献（医药）

2025-06-01·CURRENT OPINION IN IMMUNOLOGY

Pharmacotherapeutic strategies to promote regulatory T cell function in autoimmunity

Review

作者: Campbell, Daniel J ; Wright, Robert C ; Levings, Megan K

Autoimmune diseases arise when self-antigen-specific T and B cells escape central and peripheral mechanisms of tolerance. One such mechanism is control of autoreactivity by regulatory T cells (Tregs), which have an essential role in suppressing autoimmunity. Consequently, there is significant interest in developing ways to boost or restore the function of Tregs in order to prevent or treat autoimmunity, induce tolerance, and thus reduce the reliance on broadly immunosuppressive agents. Strategies include enhancing the numbers and/or function of Tregs directly in vivo or via adoptive cell therapy. Here, we review recent advances in our understanding of how pharmacologic approaches can be applied to enhance Treg function in vivo through repurposing of established drug therapies or application of new therapies. Specifically, we discuss the potential of Treg-promoting drugs, including interleukin-2 and its derivatives, and tumor necrosis factor receptor 2 agonists, as well as Treg-preserving tyrosine kinase 2 inhibitors. We discuss how co-stimulatory blockade with CTLA-4 immunoglobulin affects tolerogenic environments and consider whether lymphodepleting therapies, such as antithymocyte globulin and teplizumab, might be needed to condition the environment for better Treg-promoting effects. We focus on the potential application of Treg-promoting drugs in type 1 diabetes and draw on evidence from transplantation. With multiple pharmacotherapeutic strategies to optimize Tregs in vivo, there is significant promise for new approaches to effectively and durably induce autoimmune disease remission.

2025-04-01·DRUGS

Emerging Immunotherapies for Disease Modification of Type 1 Diabetes

Review

作者: Bruggeman, Brittany S ; Foster, Timothy P ; Haller, Michael J

Type 1 diabetes mellitus (T1DM) is characterized by the progressive, autoimmune-mediated destruction of β cells. As such, restoring immunoregulation early in the disease course is sought to retain endogenous insulin production. Nevertheless, in the more than 100 years since the discovery of insulin, treatment of T1DM has focused primarily on hormone replacement and glucose monitoring. That said, immunotherapies are widely used to interdict autoimmune and autoinflammatory diseases and are emerging as potential therapeutics seeking the preservation of β-cell function among those with T1DM. In the past 4 decades of diabetes research, several immunomodulatory therapies have been explored, culminating with the US Food and Drug Administration approval of teplizumab to delay stage 3 (clinical) onset of T1DM. Clinical trials seeking to prevent or reverse T1DM by repurposing immunotherapies approved for other autoimmune conditions and by exploring new therapeutics are ongoing. Collectively, these efforts have the potential to transform the future of diabetes care. We encapsulate the past 40 years of immunotherapy trials, take stock of our successes and failures, and chart paths forward in this new age of clinically available immune therapies for T1DM.

2025-03-24·EXPERT OPINION ON PHARMACOTHERAPY

Pharmacotherapy of type 1 diabetes – part 3: tomorrow

Review

作者: Rendell, Marc

INTRODUCTION:

The last 100 years have seen type 1 diabetes, a previously fatal disease, transformed by the administration of exogenous insulin.

AREAS COVERED:

A standard literature search using the Google and Microsoft search engines and PubMed was performed. The development of synthetic insulins with varying onsets and duration of action improved glucose control, essential to mitigate the microvascular and macrovascular consequences of diabetes. Today insulin pumps guided by continuous glucose monitors are approaching the objective of normalized glucose levels. The area of greatest development is now in attempting to suppress the immune process which results in progressive destruction of the beta cell. It is possible to identify family members of patients with type 1 diabetes who may eventually develop the disease by measuring several beta cell antibodies. Very recently teplizumab, a CD3 inhibitor, has been approved to delay the onset of hyperglycemia in these individuals.

EXPERT OPINION:

The future will see progress in immunosuppression, possibly using specific CAR-Treg cells directed at the beta cell antigens which trigger the immune process. In parallel, stem cell-derived beta cells may eventually make it possible to replace lost beta cells, resulting in a true cure for type 1 diabetes.

294

项与 Teplizumab 相关的新闻（医药）

2025-04-29

·国际糖尿病idiabetes

Paolo Pozzilli教授专访: T1D碰上肥胖，双重糖尿病来袭，我们该如何应对？| 遇见IDF·每日精粹

IDF 2025微专辑扫描二维码可查看更多内容编者按：胰岛素泵和血糖动态监测，使糖尿病患者不再真正遭受低血糖和高血糖的困扰。但在提升生活质量的同时，因不合理饮食导致肥胖，新表型双重糖尿病带来了新的临床挑战，同一患者可能同时出现1型糖尿病（T1D）和2型糖尿病（T2D）的并发症。在2025年4月7~10日曼谷举办的2025年国际糖尿病联盟世界糖尿病大会上（IDF2025），我们特邀意大利罗马生物医学自由大学 Paolo Pozzilli教授做客“遇见IDF·每日精粹”直播间，就该话题进行了深入探讨，相关核心内容整理如下。《国际糖尿病》Q1您团队提出的“双重糖尿病”概念将肥胖与β细胞自身免疫结合，提示患者心血管风险显著增加。请问“双重糖尿病”这一新临床表型具有哪些临床意义？Pozzilli教授：T1D与肥胖问题在疾病管理中正扮演着新角色。过去，典型T1D患者通常消瘦，并缺乏胰岛素。而现在，许多患者出现肥胖。由于胰岛素泵的使用，患者可以自由饮食，血糖监测和自动调节胰岛素量使低血糖风险降低，看似完美。但进食增加及伴随的外源性胰岛素用量上升，促使体重增长，导致技术诱导的T1D新表型。这带来了很多问题，特别是，同一患者可能同时出现1型和T2D的并发症。传统1型并发症主要是视网膜病变、肾病和神经病变，现在却新增了T2D的典型并发症，以心血管风险为特征的大血管病变。虽然在治疗方面，我们有大量讨论关于GLP-1受体激动剂可否批准用于T1D，但最迫切的问题是，患者需要减重，否则心血管并发症的风险将增加。我认为，对于今天的T1D患者，胰岛素泵这项新技术让生活更轻松和美好，但在提升生活质量的同时，也带来了新的挑战。我们需要根据法律法规，合理地运用现有药物进行规范治疗。《国际糖尿病》Q2您认为是否需要针对“双重糖尿病”调整传统血糖控制目标，并整合减重与免疫调节的双重干预？Pozzilli教授：免疫调节取决于β细胞功能障碍的进程。在疾病早期，T1D有典型的自身免疫过程。但若饮食不当导致超重，就会增加自身免疫过程，并导致β细胞功能障碍。人们会失去更多的β细胞，进而再需要更多的胰岛素。因此，对于T1D高危人群，如T1D患者的一级亲属，预防超重和肥胖非常重要。总之，肥胖会刺激自身免疫进程，导致β细胞功能障碍，以及促使T1D发病。《国际糖尿病》Q3现有免疫疗法难以长期维持β细胞功能，联合治疗与精准医疗已成为趋势。请问，您认为下一代免疫治疗的核心突破点是什么？Pozzilli教授：自80年代，我参与的首个环孢素国际试验开始，就已经投身于糖尿病的免疫治疗了。四十年来，许多药物试验都未能有效保护残余的β细胞功能，也无法通过刺激残余的β细胞功能来恢复其部分功能。而近期，抗CD3抗体在新诊断患者和T1D高危人群中，都显示出了治疗前景。未来，我认为可能需要联合靶向不同病理机制的抗体，因为β细胞损伤是涉及多重机制的。当下，使用抗CD3似乎很有希望，因为它可以延缓糖尿病的进程。尽管最终可能仍会患糖尿病，但早期干预可以保留更多的内源性β细胞功能。已有研究证实，保留β细胞功能的患者，长期并发症更少。一项通过在50岁的T1D患者中测量β细胞功能标志物C肽的研究发现，保留C肽的患者并发症更少，如更少的视网膜病变和神经病变。总之，我们的目标不是完全停用胰岛素，而是通过适量的胰岛素，来增强保护残余β细胞功能。《国际糖尿病》Q4您始终将患者放在首位并以患者为中心。请问，如何实现"在正确时间为合适患者选择恰当疗法"？Pozzilli教授：对患者进行分层，首先我们必须记住，T1D具有高度异质性。基本上，我们有4个不同的T1D发病年龄，即青春期前、青春期、青年成人以及50-60岁后，如成人隐匿性自身免疫糖尿病（LADA）。不同发病年龄需要差异化治疗。以LADA为例，患者在40岁或以上时发展为自身免疫性糖尿病，他们基本上是T2D患者。但因持续的自身免疫过程，他们又是T1D。对于这类患者，免疫干预能有效保护C肽水平，从而预防并发症。《国际糖尿病》Q1从teplizumab获批到干细胞教育疗法的探索，T1D治疗正在进入疾病治疗的新阶段。请问，您最期待未来哪种技术会变革T1D的治疗格局？Pozzilli教授：一方面，遗传操作在I期试验中展现了潜力，在疾病非常早期阶段，改变疾病过程，该方法虽然有趣但应用可能尚远。另一方面，人工智能（AI）对疾病其异质性也有良好处理能力，通过分析患者基因表型特征，能给我们启发来决定特定患者的最佳治疗方案，从临床角度，这很有用。当然，这并非简单听AI说，而是参考它提供的文献并独立判断。因此，我相信临床和科研都能获益于AI使用带来的便捷和优势。结语抗CD3单克隆抗体突破四十年来的治疗瓶颈，在新诊断患者和T1D高危人群中均显示出了治疗前景。期待更多药物开发，联合靶向不同病理机制，有效保护残余的β细胞功能；再通过AI技术的合理利用，早日解决双重糖尿病难题，惠及患者。专家简介Paolo Pozzilli教授意大利罗马生物医学自由大学意大利罗马生物医学自由大学内分泌学教授英国伦敦玛丽女王大学糖尿病和临床研究教授专注于1型糖尿病（T1D）的发病机制和预防发表超过560篇关于糖尿病的科学文章、书籍和综述积极参与1型和2型糖尿病新型疗法的临床试验《糖尿病代谢研究与评论》杂志主编声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

免疫疗法

2025-04-09

·药闻康策

多个药品加收进出口关税，医药市场或将洗牌

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策2025年4月2日，美国政府宣布对中国输美商品征收“对等关税”。4月4日，国务院关税税则委员会办公室发布公告，决定自2025年4月10日12时01分起，对原产于美国的所有进口商品加征34%关税。并且现行保税、减免税政策不变，此次加征的关税不予减免。01美国对亚洲部分国家征收关税税率对比美国对华税率达到54%目前，美国对部分其他亚洲国家征收的关税从26%到46%不等，日前，其再次签署两项行政命令，宣布要对所有贸易伙伴，都设10%的关税，以此作为“最低基准”。同时还要对另外数十个国家和地区，在这个“最低基准”上加更多的税，对中国税率就达到了34%，再加上此前加征的20%，现在美国对华税率已经升到了54%。02对原产于美国的所有进口商品，包括哪些商品？美国对华加征关税的商品范围涉及半导体、新能源、高端制造等领域，但是对于铜、药品、半导体、木材制品、某些关键矿物和能源产品等被列入了豁免清单。03大部分药品获得豁免除含胰岛素的未配定剂量药品、含去甲麻黄碱及其盐的未配定剂量药品、含其他抗疟疾活性成分的未配定剂量药品和含去甲麻黄碱及其盐的已配定剂量药品等四个税号外，豁免清单中纳入了绝大部分药品制剂（包括各类化药制剂和疫苗、抗体等生物制品），不受此次对华加征34%关税影响，目前关税水平为20%。04未来哪些药品或将被加收关税据彭博新闻社，白宫正在考虑对制药业发起所谓的232条款关税调查，随着美国推进对药品进口征税的计划，制药业的关税暂缓可能不会持续太久。未来加税药品的六大潜在方向：05对药品产业链的具体影响对于创新药：关税豁免利好创新药：美国对药品的豁免政策为国内创新药企通过BD（商业拓展）合作、对外授权等模式出海提供了窗口期。例如信达生物与礼来合作的胰岛素类似物，采用 “专利授权 + 技术入股” 模式，在美销售可享受本土化生产税收优惠；恒瑞医药斥资 12 亿美元收购美国 Provention Bio，获得糖尿病药物 Tzield 全球权益，直接打通在美商业化通道。长期挑战与机遇：虽然短期内关税对创新药直接影响有限，但长远来看，企业需积极应对国际准入标准、专利壁垒等出海挑战。对于原料药：中国医药保健品进出口商会数据显示，2024年，我国原料药出口额429.8亿美元，同比增长5.1%；从我国原料药出口的国家看，美国出口额位列第二，2024年，我国对美国出口原料药45.2亿美元，同比增长12.0%。部分原料药豁免品种仍保持价格竞争力。2024年我国原料药前十大出口市场（亿美元）数据来源：中国医保商会对于生物制品：以人血白蛋白为例，其进口占比约70%，若后期提高进出口关税，将倒逼国产替代加速。（数据来源：中检所，西南医药团体）对于敏感品类：布洛芬、去甲伪麻黄碱等未豁免品种出口受阻，相关企业可通过向印度、东南亚等第三国转口或调整生产工艺等方式减少损失。06加速区域市场格局变化中药、药店及流通行业等以内需为主的细分领域受关税影响较小，政策支持下的行业整合（如央国企改革）也将进一步提升集中度。借助医保谈判和集采等“以量换价”政策，可推动国产创新药的临床应用，加速国产仿制药可替代速度，进一步保护本土品种，可对冲外部风险。07中国企业应对策略技术创新：企业应加强技术创新，提高产品质量和生产效率，降低生产成本，提升自身的技术水平和产品的国际竞争力。开拓多元市场：企业应拓展欧洲、东南亚等多元化市场，降低对美国市场的依赖，寻找新的市场机会。政策响应与合规管理：密切关注后续政策动态，优化关税应对方案（如转口贸易、本土化生产等）。 (来源:易联招采)药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

并购疫苗专利到期

2025-03-14

·GlobeNewswire-Health Care

Tiziana Life Sciences Regains Compliance with Nasdaq Listing Minimum Bid Price Rule

NEW YORK, March 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that it has received a notification from the Nasdaq Stock Market LLC (“Nasdaq”) Listing Qualifications Department informing the Company that it has regained compliance with the Nasdaq listing minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange. Tiziana was previously notified by Nasdaq on January 29, 2025 that it was not in compliance with the minimum bid-price listing rule (under Rule 5550(a)(2)) because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. To regain compliance, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days which was met on March 12, 2025. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2), and this matter is now closed. The Company’s securities will continue to be listed and traded on The Nasdaq Stock Market. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www.pnas.org/doi/10.1073/pnas.2220272120[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

免疫疗法临床2期

100 项与 Teplizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09013	Teplizumab	-	DB06606

研发状态

批准上市

10 条最早获批的记录,

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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

未上市

10 条进展最快的记录,

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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
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
非胰岛素依赖型糖尿病1	临床阶段不明	美国	Sanofi	2024-09-27

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临床结果

适应症

分期

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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


NCT04270942 (CTgov)	临床2期	1型糖尿病	6	Teplizumab	鏇衊觸繭願鏇蓋壓衊網 = 夢製鹹遞蓋積鏇襯繭鏇構淵醖鏇襯糧鑰鏇壓選 (齋選衊製範蓋鬱窪構廠, 觸積醖艱壓夢獵構鹹觸 ~ 選襯膚觸鹽獵鬱襯範餘) 更多	-	2025-02-12
NCT01030861 (Pubmed \| J Clin Invest)	临床2期	1型糖尿病	-	Teplizumab	窪餘鬱網齋製襯廠觸範(築淵鏇鏇衊衊餘鏇襯衊) = reduced with teplizumab treatment 鑰繭夢廠積艱範憲憲鬱 (齋鹹醖襯鏇範積網選鹹 ) 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	淵顧鑰構遞憲網獵簾選(憲鹽選膚夢齋顧選顧範) = 積憲繭餘鹽齋簾遞窪鬱淵窪構積醖鏇範鏇齋壓 (衊構網鹽襯範鹹鹽衊選, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	淵顧鑰構遞憲網獵簾選(憲鹽選膚夢齋顧選顧範) = 醖遞網積製鑰衊艱淵獵淵窪構積醖鏇範鏇齋壓 (衊構網鹽襯範鹹鹽衊選, -1.94 ~ -1.67) 更多
ADA2024	N/A	1型糖尿病	-	Teplizumab	鹹蓋觸壓鏇鹽選憲繭襯(膚壓鏇壓網願憲鏇糧範) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 膚選窪憲齋製廠艱遞顧 (鹹廠餘鹽蓋齋築遞廠鑰 ) 更多	-	2024-06-14
				Placebo
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	製廠淵鑰餘築壓鹹窪積(廠繭淵範範衊衊廠觸範) = 襯鑰顧構廠鬱夢憲廠襯網構鏇願鑰構鑰築繭壓 (築壓築網顧襯簾齋鹽顧, 醖壓遞鬱蓋廠選範範範 ~ 觸築餘觸觸願簾醖顧選) 更多	-	2024-04-24
				teplizumab (Teplizumab)	製廠淵鑰餘築壓鹹窪積(廠繭淵範範衊衊廠觸範) = 鏇鏇齋鹹築餘淵餘獵窪網構鏇願鑰構鑰築繭壓 (築壓築網顧襯簾齋鹽顧, 窪鹹衊顧選網窪鹹糧鏇 ~ 鏇願網簾製膚願淵淵遞) 更多
NCT00920582 (CTgov)	临床3期	1型糖尿病	254	Teplizumab Herold Regimen (Herold Regimen)	壓壓繭醖鬱願鹹網製齋 = 餘餘選壓憲鹹顧夢廠醖選壓獵膚鹹顧製窪醖壓 (壓壓網願醖鏇糧鹽壓齋, 衊築壓窪製艱製廠齋鹽 ~ 廠鹹願醖鹽構積憲糧衊) 更多	-	2023-12-20
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	壓壓繭醖鬱願鹹網製齋 = 繭願憲鬱餘範夢窪鬱獵選壓獵膚鹹顧製窪醖壓 (壓壓網願醖鏇糧鹽壓齋, 顧糧觸鬱膚構製網窪構 ~ 壓獵蓋築膚鹹膚窪餘襯) 更多
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	顧獵襯選醖膚衊膚鬱憲 = 簾醖壓糧構觸壓觸窪窪醖選觸積獵網襯鑰範廠 (窪壓憲顧廠獵襯簾餘鹹, 觸襯蓋廠鏇鏇膚範構蓋 ~ 積製鹽淵夢鑰夢蓋築鬱) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	襯範廠願壓齋憲遞醖願 = 鏇願簾鏇餘築夢選觸顧選遞積淵構壓齋窪襯製 (艱廠廠糧蓋鹹觸餘鬱醖, 鹹遞構鑰糧築獵積鑰繭 ~ 淵範範艱鏇鏇鑰廠獵構) 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	窪糧齋鏇願襯壓築鏇遞(糧壓憲衊願齋觸願獵觸) = 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. 淵膚艱範構蓋鬱窪簾遞 (鏇廠夢襯簾遞淵獵鹽觸 ) 更多	积极	2023-10-18
				placebo
FOCIS2023	N/A	1型糖尿病 EBVsero+	-	teplizumab (EBVsero+)	觸簾齋築醖鏇鹹壓衊醖(糧鹽艱遞淵簾壓製襯網) = 廠鹽製衊夢齋衊衊簾製衊糧網衊願憲鹹構鹹鬱 (蓋製憲網網顧糧遞鏇襯 )	积极	2023-06-20
				teplizumab (EBVsero-)	觸簾齋築醖鏇鹹壓衊醖(糧鹽艱遞淵簾壓製襯網) = 憲鹹餘選選窪鹹膚製築衊糧網衊願憲鹹構鹹鬱 (蓋製憲網網顧糧遞鏇襯 )
NCT03751007 (Phase 1b/2a, EASD2021)	临床1/2期	1型糖尿病 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	鏇齋壓糧窪憲鹹廠艱願(簾鬱蓋繭製糧憲築選積) = 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. 衊製繭積構鏇廠艱鹹艱 (鬱餘夢願窪築衊選範廠 ) 更多	积极	2021-10-01
				AG019/teplizumab combination therapy