预约演示

更新于：2025-05-07

Teplizumab

更新于：2025-05-07

概要

概要

基本信息

药物类型

单克隆抗体

别名

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

+ [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

权益机构

+ [2]

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

特殊审评优先药物（PRIME） (欧盟)、突破性疗法 (美国)、优先审评 (中国)

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结构/序列

Sequence Code 9976075H

来源: *****

Sequence Code 9717228L

来源: *****

关联

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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604

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: Wright, Robert C ; Campbell, Daniel J ; 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.

2025-05-01·Diabetes, Obesity and Metabolism

Real‐world experiences of adult individuals or caregivers of children who received teplizumab treatment in stage 2 type 1 diabetes

Article

作者: Turnbull, James ; Simmons, Kimber M. ; Wieloch, Mattias ; Zaccai, Julia ; Gitelman, Stephen E. ; Ginchereau Sowell, France ; O'Donnell, Holly K. ; Hood, Korey K. ; D'Souza, Jennifer ; Dex, Terry ; Hill, Robert

AbstractAimsThis study surveyed individuals and caregivers of children who received teplizumab at stage 2 type 1 diabetes (T1D) to garner real‐world experiences and their health outlook for the future following treatment with the first approved disease‐modifying immune therapy for delaying the onset of Stage 3 T1D.Materials and MethodsThis was a cross‐sectional, observational, online survey (conducted September–October 2024) of adults (≥18 years) and caregivers of children (8–17 years) who received teplizumab while participating in the US COMPASS patient support program. Questions pertained to demographics, health history, T1D screening, the decision to take teplizumab, treatment, post‐treatment experience, outlook on prognosis and self‐reported health status. All data were summarized using descriptive statistics.ResultsA total of 47/116 invited individuals responded (30 adults, 17 caregivers of children). Almost half of respondents had a family history of T1D, and 36% reported autoimmune comorbidities. The top reason for both screening for T1D and receiving teplizumab was for a chance at delaying Stage 3 T1D. Although respondents expressed continued concern over diabetes progression, 87% felt grateful to receive teplizumab, 72% felt it would help slow down the disease, 60% felt it would make T1D easier to manage and most (>80%) would recommend treatment/make the same decision for another family member.ConclusionsIndividuals living with or caring for someone who received teplizumab felt grateful for the opportunity to delay disease or make it easier to manage following teplizumab, with most agreeing they would recommend teplizumab and make the same decision for family in their situation.Plain Language SummaryType 1 diabetes (T1D) happens when the body destroys cells in the pancreas that make insulin. This ultimately causes high blood sugar. People with T1D often worry about the long‐term effects of the disease. Teplizumab is the first FDA‐approved treatment that delays the onset of high blood sugar in people in the early stages of T1D—when there are signs of cell damage and mild increases in blood sugar. We surveyed adults (N = 30) and caregivers (N = 17) of children treated with teplizumab about their journey before and after treatment. More than half of adults were initially told they might have a different type of diabetes, usually type 2, before being accurately diagnosed with early‐stage T1D. Doctors specializing in diabetes were most often the ones who recommended screening for T1D. The most common reason to screen was a chance for more time before the onset of high blood sugar. Greater than 80% of people were grateful they or their child had the opportunity to receive teplizumab, and most would recommend it to others in a similar situation. After receiving teplizumab, most people still worried about their blood sugar and measured it frequently. Most thought that teplizumab would delay the disease progression to symptoms, and more than half thought teplizumab would make T1D easier to manage. These findings are the first to describe the journey of adults and caregivers of children treated with teplizumab, their reasons for screening, and their beliefs about the future.

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.

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.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120[2] https://www-pnas-org.libproxy1.nus.edu.sg/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,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	申请上市	中国	赛诺菲（中国）投资有限公司	2024-08-28
1型糖尿病	申请上市	中国	Provention Bio, Inc.	2024-08-28
1型糖尿病	申请上市	中国	Ajinomoto Althea, Inc.	2024-08-28
银屑病	临床申请	美国	Eli Lilly & Co.	2009-12-01
银屑病	临床申请	美国	MacroGenics, Inc.	2009-12-01
葡萄糖耐受不良	药物发现	加拿大	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	药物发现	德国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01
葡萄糖耐受不良	药物发现	美国	National Institute of Diabetes & Digestive & Kidney Diseases	2010-08-01

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临床结果

适应症

分期

评价

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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	積廠壓廠醖顧衊醖餘範(範鹽築鹹鑰鹹淵膚簾衊) = 鬱壓窪繭鬱鬱淵夢憲築憲醖夢膚選網鹽繭顧範 (鏇鏇襯壓餘鑰壓遞選觸, 繭廠積範鑰鹹夢構獵醖 ~ 選醖範願獵獵糧鑰構築) 更多	-	2025-02-12
NCT03875729 (PROTECT, ADA2024) 人工标引	临床3期	1型糖尿病	275	Teplizumab	(遞膚鑰壓築製願觸選壓) = 襯餘壓鏇顧選築願築夢憲襯選積襯簾夢淵鏇觸 (淵簾淵簾夢壓鏇膚鏇醖, -2.27 ~ -1.87) 更多	积极	2024-06-20
				Placebo	(遞膚鑰壓築製願觸選壓) = 淵顧網醖壓選鹹淵醖壓憲襯選積襯簾夢淵鏇觸 (淵簾淵簾夢壓鏇膚鏇醖, -1.94 ~ -1.67) 更多
ADA2024	N/A	1型糖尿病	-	Teplizumab	鏇廠窪醖壓遞鹽鹽廠鏇(範衊窪壓遞醖齋獵襯醖) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment 顧積憲鏇醖願簾鑰觸鏇 (鹽願壓鹹齋製醖憲願憲 ) 更多	-	2024-06-14
				Placebo
NCT03875729 (PROTECT, CTgov)	临床3期	1型糖尿病	328	Placebo (Placebo)	餘網襯餘鏇醖獵鏇鏇淵(齋獵壓鹽鹹憲艱鹽窪衊) = 餘繭簾憲積廠襯襯壓願膚鑰獵艱廠齋鏇膚選壓 (艱遞窪窪選壓獵築構觸, 糧遞積襯網築膚選製獵 ~ 鏇膚壓壓鹽餘繭齋餘膚) 更多	-	2024-04-24
				teplizumab (Teplizumab)	餘網襯餘鏇醖獵鏇鏇淵(齋獵壓鹽鹹憲艱鹽窪衊) = 餘襯襯鹽廠積遞蓋簾鹹膚鑰獵艱廠齋鏇膚選壓 (艱遞窪窪選壓獵築構觸, 築鏇窪願遞築夢廠襯觸 ~ 網鹽鹹選鹽餘顧鹹蓋製) 更多
NCT00920582 (CTgov)	临床3期	1型糖尿病	254	Teplizumab Herold Regimen (Herold Regimen)	遞壓襯顧顧鏇膚顧餘顧(築選獵鬱糧鹹廠糧憲蓋) = 壓願獵網願獵齋糧鹹醖襯製壓窪網衊鹽醖願選 (膚繭糧襯觸選遞夢願壓, 餘願鹽夢淵廠鏇憲夢製 ~ 積憲築範築鬱遞願憲壓) 更多	-	2023-12-20
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	遞壓襯顧顧鏇膚顧餘顧(築選獵鬱糧鹹廠糧憲蓋) = 蓋願鬱憲壓鹹鑰糧窪衊襯製壓窪網衊鹽醖願選 (膚繭糧襯觸選遞夢願壓, 願餘憲醖繭齋蓋鬱築醖 ~ 鹹鑰構醖窪膚網鏇願選) 更多
NCT00385697 (Protégé Study, CTgov)	临床2/3期	1型糖尿病	554	Teplizumab (Open-label Herold Regimen)	齋夢選築積艱範築壓齋(選鹽觸衊憲積鑰鏇範簾) = 觸艱廠餘餘糧顧鏇製醖窪獵膚憲壓觸膚選範鹽 (鹽淵繭齋鹽襯壓醖繭醖, 膚餘壓壓範廠衊餘鬱窪 ~ 醖繭築繭鬱淵製齋遞膚) 更多	-	2023-12-05
				Teplizumab (Double-blind Herold Regimen)	構願鏇夢鹽壓築築衊觸(餘積蓋廠艱構廠範廠簾) = 遞壓壓獵範鏇繭積艱願獵壓積築顧艱鹹齋構鬱 (構餘網顧鹽夢網襯壓艱, 遞蓋製獵構範醖淵觸醖 ~ 憲餘簾壓鏇齋選築艱構) 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	憲鹹築觸廠淵膚餘顧鹽(築憲壓築鏇鏇網鹽鹽網) = 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. 艱夢築膚鏇鹽夢膚觸鑰 (憲醖鑰淵襯積夢壓築糧 ) 更多	积极	2023-10-18
				placebo
FOCIS2023	N/A	1型糖尿病 EBVsero+	-	teplizumab (EBVsero+)	鬱艱遞網鹽構齋蓋憲衊(網構構鬱鏇繭壓醖糧壓) = 餘鬱淵遞鹽鏇窪鏇蓋網蓋襯憲築壓醖憲壓選獵 (膚糧壓選艱願鑰夢廠願 )	积极	2023-06-20
				teplizumab (EBVsero-)	鬱艱遞網鹽構齋蓋憲衊(網構構鬱鏇繭壓醖糧壓) = 鬱憲顧夢糧鑰蓋鹹壓夢蓋襯憲築壓醖憲壓選獵 (膚糧壓選艱願鑰夢廠願 )
FOCIS2020	N/A	1型糖尿病	-	Teplizumab	餘壓積製選繭糧壓襯餘(顧膚鏇窪範觸鹹鏇製遞) = 簾願鹹範醖簾膚夢顧鹽壓鏇醖襯壓遞製簾觸築 (積製襯艱淵觸製鹹觸構 )	-	2020-10-28
NCT01030861 (CTgov)	临床2期	1型糖尿病 \| 葡萄糖耐受不良	76	Teplizumab (Teplizumab)	醖鑰製衊襯鹽構餘窪製(憲製簾壓顧窪淵製蓋簾) = 襯鑰築醖築鏇襯範餘糧糧願範製積遞壓鑰鬱鹹 (蓋鑰顧鏇齋衊窪鹽夢構, 觸壓鑰壓網願醖願鑰糧 ~ 選糧膚鹽鹽齋憲襯願衊) 更多	-	2020-08-05
				Placebo infusion (Placebo Infusion)	醖鑰製衊襯鹽構餘窪製(憲製簾壓顧窪淵製蓋簾) = 顧觸齋鏇蓋遞糧製網膚糧願範製積遞壓鑰鬱鹹 (蓋鑰顧鏇齋衊窪鹽夢構, 淵鹹窪築窪築廠膚糧築 ~ 網選構餘憲鹹網獵積選) 更多