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Last update 15 Sep 2025

Teplizumab

Last update 15 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [7]

Target

CD3

Action

inhibitors

Mechanism

CD3 inhibitors(T cell surface glycoprotein CD3 inhibitors)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Inactive Indication

Chronic large plaque psoriasisGlucose Intolerance

Originator Organization

Active Organization

+ [4]

Inactive Organization

National Institute of Diabetes & Digestive & Kidney Diseases

License Organization

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (17 Nov 2022),

Diabetes Mellitus, Type 1

RegulationPriority Review (United States), Breakthrough Therapy (United States), PRIME (European Union), Priority Review (China)

Structure/Sequence

Sequence Code 9717228L

Source: *****

Sequence Code 9976075H

Source: *****

Clinical Trials associated with Teplizumab

NCT07088068

/ RecruitingPhase 3

A Randomized, Double-blind, 2-arm, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment.
The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Start Date06 Aug 2025

Sponsor / Collaborator

Sanofi

NCT06791291

/ RecruitingPhase 2

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.

Start Date25 Jul 2025

Sponsor / Collaborator

Sanofi

NCT06892002

/ CompletedNot Applicable

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.

Start Date11 Feb 2025

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Teplizumab

100 Translational Medicine associated with Teplizumab

100 Patents (Medical) associated with Teplizumab

608

Literatures (Medical) associated with Teplizumab

01 Oct 2025·JOURNAL OF DIABETES AND ITS COMPLICATIONS

What type 1 diabetes endotype is most suitable for anti-CD3 antibodies prevention trials?

Review

Author: Wilson, Maria Aurora Roma ; 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.

01 Oct 2025·Nature Reviews Endocrinology

Type 1 diabetes mellitus prevention: present and future

Review

Author: Forbes, Josephine M ; Henriques, Francisca L ; Buckle, Irina

Type 1 diabetes mellitus (T1DM) is a chronic disease with an increasing global incidence. The mortality associated with T1DM complications emphasizes the urgency of developing therapeutic strategies to prevent or delay the onset of T1DM. Historically, T1DM was solely described as a T cell-mediated disease. However, the role of β-cells as active participants in the immune-mediated damage is now well appreciated. Indeed, heterogeneity, vulnerability to stressors and the ability of β-cells to act as antigen-presenting cells has altered the perspective of what is necessary for effective disease prevention and ongoing β-cell preservation. Currently, teplizumab, an Fc-receptor non-binding humanized CD3-specific monoclonal antibody, is the only therapy approved by the FDA for the delay of T1DM onset. The intravenous administration, generalized immunosuppression and adverse effects mean that the transition to routine clinical practice is not without challenges. However, teplizumab could lead to the development of more accessible therapies. In this Review, we explore current and potential therapeutics for T1DM prevention. We offer alternative approaches, such as targeting the receptor for advanced glycation end products (RAGE). RAGE is a pattern recognition receptor that engages a wide range of ligands, including advanced glycation end products (AGEs; a family of molecules that includes the well described marker of long-term glucose concentrations, HbA_1c).

08 Aug 2025·Journal of Clinical Medicine

Historically Based Perspective on the Immunotherapy of Type 1 Diabetes: Where We Have Been, Where We Are, and Where We May Go.

Article

Author: Cavalli, Eugenio ; Nicoletti, Giuseppe Rosario Pietro ; Nicoletti, Ferdinando

Systematic Background/Objectives: Type 1 diabetes mellitus (T1DM) is an autoimmune condition in which pancreatic β-cells are selectively destroyed, predominantly by autoreactive T lymphocytes. Despite decades of research, the achievement of durable immune tolerance remains elusive. This review presents a historically grounded and forward-looking perspective on the evolution of immunotherapy in T1DM, from early immunosuppressive interventions to advanced precision-based cellular approaches. Specifically, we focus on systemic immunosuppressants (e.g., corticosteroids, cyclosporine), monoclonal antibodies (e.g., anti-CD3, anti-IL-1, anti-TNF), regulatory cell-based approaches (e.g., Tregs, CAR-Tregs, MDSCs), and β-cell replacement strategies using stem cell-derived islets. Methods: We analyzed major clinical and translational milestones in immunotherapy for T1DM, with particular attention to the transition from broad immunosuppression to targeted modulation of immune pathways. Emerging data on cell-based therapies, artificial intelligence (AI)-driven stratification, and personalized intervention timing have been incorporated to provide a comprehensive overview of current and future directions. Results: Initial therapies such as corticosteroids and cyclosporine offered proof-of-concept for immune modulation, yet suffered from relapse and toxicity. The introduction of monoclonal antibodies (e.g., teplizumab) marked a shift toward immune-specific intervention, particularly in stage 2 preclinical T1DM. More recent approaches include low-dose IL-2, checkpoint modulation, and antigen-specific tolerance strategies. Cellular therapies such as Treg adoptive transfer, chimeric antigen receptor Tregs (CAR-Tregs), and stem cell-derived islet replacements (e.g., VX-880) have shown promise in preserving β-cell function and modulating autoimmunity. Myeloid-derived suppressor cells (MDSCs), although still preclinical, represent a complementary avenue for immune tolerance induction. Concurrently, AI-based models are emerging as tools to stratify risk and personalize immunotherapeutic timing, enhancing trial design and outcome prediction. Conclusions: In conclusion, the historical progression from broad immunosuppression to precision-driven strategies underscores the importance of stage-specific, mechanism-based interventions in T1DM. The convergence of targeted biologics, regenerative cell therapies, and β-cell replacement approaches, supported by AI-enabled patient stratification, offers a realistic path toward durable immune tolerance and functional β-cell preservation. Continued integration of these modalities, coupled with rigorous long-term evaluation, will be essential to transform these scientific advances into sustained clinical benefit.

171

News (Medical) associated with Teplizumab

12 Sep 2025

·www.globenewswire.com

Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes

Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older, with stage 2 T1D compared to placebo Additional regulatory reviews are ongoing across different disease stages by regulatory authorities around the world September 10, 2025- The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the first disease-modifying therapy in autoimmune type 1 diabetes (T1D) indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 T1D. The review was completed under priority review, following the recognition by NMPA of Tzield’s innovative profile and the benefit it brings to pediatric patients. The approval is based on the positive results from the TN-10 phase 2 study, which demonstrated Tzield's ability to delay the onset of stage 3 T1D, compared to placebo. The pivotal study demonstrated that a once-daily, single and consecutive 14-day course of Tzield delayed the median onset of stage 3 T1D by 48.4 months vs 24.4 months observed in the placebo group. “This approval represents the beginning of a new era of care for stage 2 type 1 diabetes patients in China, one focused on the potential of Tzield to prevent the natural progression of T1D by its unique beta-cell function preserving capabilities,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “Tzield is the first approved advanced therapy that slows down the loss of beta cell function, potentially giving people living with stage 2 T1D more time without the daily treatment burden. We are proud to bring this innovative medicine to China, and we remain committed to working with local stakeholders to advance diabetes care.” The approval aligns with recent Chinese expert consensus guidelines that recognize the importance of protecting beta-cell function as a pivotal component in the management of autoimmune T1D. These guidelines, published in November 2024, highlighted Tzield’s potential therapeutic value, which has now been validated by this approval, demonstrating Tzield’s relevance in addressing this significant clinical unmet need in the treatment of autoimmune T1D. Tzield is approved for the treatment of adult and pediatric individuals aged eight years and older, living with stage 2 type 1 diabetes, in the US, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait. Regulatory reviews are ongoing in the EU and other jurisdictions around the world. Tzield (teplizumab) is a CD3-directed monoclonal antibody. Tzield is the first and only disease modifying therapy in autoimmune T1D; it was first approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in China, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Regulatory reviews are ongoing in the EU and other jurisdictions around the world. T1D is a progressive autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. There are four stages to the progression of T1D: In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic. In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells/beta cell function. Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy. Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cells remain (it’s been estimated that the beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack. Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical ResultPriority Review

22 May 2025

·www.prnewswire.com

Laureate Announced for Hamm International Prize for Diabetes Research

Honoree has made outstanding contributions toward understanding the pathogenesis and prevention of Type 1 diabetes OKLAHOMA CITY, May 22, 2025 /PRNewswire/ -- The prestigious Harold Hamm International Prize for Biomedical Research in Diabetes, an honor bestowed by OU Health Harold Hamm Diabetes Center at the University of Oklahoma Health Sciences, will be awarded this fall to Professor Dr. Anette-Gabriele Ziegler, Director of the Institute of Diabetes Research, Helmholtz Munich, German Research Center for Environmental Health. She is also Chair in Diabetes and Gestational Diabetes at Technische Universität München, School of Medicine. She is being honored for her research to understand the pathogenesis of Type 1 diabetes and efforts toward its prediction, early diagnosis and prevention. Continue Reading Professor Dr. Anette-Gabriele Ziegler, director of the Institute of Diabetes Research at the Helmholtz Munich, German Research Center for Environmental Health, has been selected as the 2025 recipient of the prestigious OU Health Herald Hamm Diabetes Center's Harold Hamm International Prize for Biomedical Research in Diabetes. The Hamm Prize recognizes and encourages lasting advances in research related to Type 1 or Type 2 diabetes. It is awarded to an individual who has either demonstrated lifelong contributions to the field or realized a singular advance, especially one that promotes curative potential. The honor includes a $250,000 award, the largest of its kind in the world. It was established to recognize and promote lasting achievements in diabetes research focused on progress toward a cure. "The award is an incredible motivation to look ahead and continue on the path toward understanding the pathogenesis of Type 1 diabetes and developing preventive therapies – with the ultimate goal of finding a cure," Ziegler said. The prize, established in 2012, is named for Harold Hamm, chairman and chief executive officer of Oklahoma-based Continental Resources Inc., who provided an endowment to fund the prize in perpetuity. The Hamm Prize laureate is selected by a rotating jury of national and international leaders in the diabetes research community and is awarded every two years. "This prize honors work that changes the course of science – and Dr. Ziegler's research does exactly that. Her leadership in uncovering how Type 1 diabetes begins and how we might stop it before it starts is the kind of bold, life-changing progress this prize was meant to recognize. Her work fuels our hope – and brings us all one step closer to the cure," Hamm said. Ziegler's research has been at the forefront of translating important research questions into longitudinal studies, including more than 20 clinical trials, as well as implementing findings into public health. Her achievements include: Launched BabyDiab, the first birth cohort to study when and how Type 1 diabetes begins. Launched Fr1da, a public screening program to detect early signs of Type 1 diabetes, now a model for similar global efforts. Initiated and serves as speaker of GPPAD (Global Platform for the Prevention of Autoimmune Diabetes), a European platform to translate knowledge about disease pathogenesis into trials seeking to prevent Type 1 diabetes. More than 2,000 infants have been enrolled in GPPAD's clinical trials and screened for genetic risk of Type 1 diabetes. Conducted research that led to a landmark clinical trial resulting in Food and Drug Administration approval for teplizumab, the first immunotherapy drug shown to delay the onset of Type 1 diabetes in at-risk individuals. In addition, Ziegler has made the following research discoveries: Autoimmunity to insulin is a key starting point for Type 1 diabetes in children, and Type 1 diabetes susceptibility genes predispose for autoimmunity. Islet autoimmunity (when the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas) starts early in life, with a peak incidence around age 1 to 2. Children with two or more islet autoantibodies almost always develop diabetes. Respiratory viral infections in early life, including COVID-19, raise the risk of islet autoimmunity in genetically at-risk children. Early changes in blood sugar and immune activity appear to precede the onset of autoimmunity to insulin. A physician who conducts research, Ziegler said caring for patients has informed her career as a scientist. "My mentor always used to say, 'A researcher is the best doctor,'" she said. "I'm not sure if the reverse is true, but my daily work with people living with diabetes and my experience as a physician have certainly shaped my research. They have especially influenced my strong focus on translational research, clinical trials, and investigating the origins of the disease in humans." Ziegler will receive the Hamm Prize during a gala in October. Jed Friedman, Ph.D., director of Harold Hamm Diabetes Center, said Ziegler's distinguished research career has significantly advanced the aim of preventing Type 1 diabetes. "Professor Dr. Ziegler's visionary leadership and unwavering commitment have not only advanced scientific understanding but also paved the way for novel interventions that improve patient outcomes by delaying the onset of Type 1 diabetes," Friedman said. "Her work exemplifies the integration of rigorous research with compassionate clinical application, embodying the highest ideals of medical science. We are privileged to honor [her] for her unparalleled contributions to diabetes research and her enduring impact on public health." About the project For more information about the Harold Hamm International Prize for Biomedical Research in Diabetes, visit the prize website here. About the University of Oklahoma Founded in 1890, the University of Oklahoma is a public research university with campuses in Norman, Oklahoma City and Tulsa. As the state's flagship university, OU serves the educational, cultural, economic and health care needs of the state, region and nation. In Oklahoma City, OU Health Sciences is one of the nation's few academic health centers with seven health profession colleges located on the same campus. OU Health Sciences serves approximately 4,000 students in more than 70 undergraduate and graduate degree programs spanning Oklahoma City and Tulsa and is the leading research institution in Oklahoma. For more information about OU Health Sciences, visit . SOURCE University of Oklahoma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical StudyImmunotherapy

14 Mar 2025

·www.globenewswire.com

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

ImmunotherapyPhase 2

100 Deals associated with Teplizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09013	Teplizumab	-	DB06606

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	United States	Provention Bio, Inc.	17 Nov 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Glucose Intolerance	Phase 2	United States	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Phase 2	Canada	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Phase 2	Germany	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Chronic large plaque psoriasis	Phase 2	United States	MacroGenics, Inc.	01 Dec 2009
Chronic large plaque psoriasis	Phase 2	United States	Eli Lilly & Co.	01 Dec 2009
Diabetes Mellitus, Type 2	Clinical	United States	Sanofi	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TN-10 Extension (ADA2025)	Phase 2	Diabetes Mellitus, Type 1	6	Teplizumab	yhoccogzkt(rhzpyqadtp) = pzcbmubzrg ygnsgdkghs (qijqmhjqdw, 0.209) View more	Positive	20 Jun 2025
NCT04270942 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	6	Teplizumab	fmmtvujmhq = ixmpcwlgxi ycqjbxxvqy (olrlktperh, dubgkolqpv - wlnrvzwuys) View more	-	12 Feb 2025
NCT01030861 (Pubmed \| J Clin Invest)	Phase 2	Diabetes Mellitus, Type 1	-	Teplizumab	tnkzdddzty(zcgmvxzqjg) = reduced with teplizumab treatment cgmzmlywrb (tbwlahpuga ) View more	Positive	13 Aug 2024
NCT03875729 (PROTECT, ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 1	275	Teplizumab	xbvdbzrutd(epexvrhuji) = mvezjfgfvd xbdthtlpqc (rpayawauvb, -2.27 to -1.87) View more	Positive	20 Jun 2024
				Placebo	xbvdbzrutd(epexvrhuji) = azluwmqzmd xbdthtlpqc (rpayawauvb, -1.94 to -1.67) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 1	-	Teplizumab	pirizcvkge(kpfacengdx) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment thzbkhapto (uglxyccmsv ) View more	-	14 Jun 2024
				Placebo
NCT03875729 (PROTECT, CTgov)	Phase 3	Diabetes Mellitus, Type 1	328	Placebo (Placebo)	zzgxuomlhy(unsbmoneqm) = jpgkvvvaif bxeqseggtb (zzsdtgcavy, qgjxajxsyh - evuhdcvpda) View more	-	24 Apr 2024
				teplizumab (Teplizumab)	zzgxuomlhy(unsbmoneqm) = cgbmmmszwv bxeqseggtb (zzsdtgcavy, eeflsmqvsr - bcpsvrcdmt) View more
NCT00920582 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	254	Teplizumab Herold Regimen (Herold Regimen)	ayisyvvndf = rpptudogbo lguzzmibob (zxwlwvxosq, bqfhebwwvt - jmvufhttgi) View more	-	20 Dec 2023
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	ayisyvvndf = wfggbnvshl lguzzmibob (zxwlwvxosq, nvnhyhnqlk - wcvregfeaf) View more
NCT00385697 (Protégé Study, CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	554	Teplizumab (Open-label Herold Regimen)	qsivwptwgd = ofwxqxbjqz xgiohrvqvy (aqlfhurhxz, rtkmgbmpix - stecpqwoku) View more	-	05 Dec 2023
				Teplizumab (Double-blind Herold Regimen)	idfftldujg = ylpesutfse mtawfafxmr (kseartwtac, pjekcnmhzp - udlspfkhlk) View more
NCT03875729 (PROTECT, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 1	-	Teplizumab	wdfdbwmjsi(zxwanookmj) = 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. lscxogayvs (unnauflceb ) View more	Positive	18 Oct 2023
				placebo
NCT03751007 (Phase 1b/2a, EASD2021)	Phase 1/2	Diabetes Mellitus, Type 1 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	lnagafmnfq(fwglfhazpa) = 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. chphmjqnzq (raqzgyetoq ) View more	Positive	01 Oct 2021
				AG019/teplizumab combination therapy

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