Teplizumab

Medical uses

Teplizumab is indicated to delay the onset of stage 3 type1 diabetes in people aged eight years of age and older with stage 2 type1 diabetes.

History

Teplizumab was developed at the University of Chicago in partnership with Ortho Pharmaceutical, and was then further developed at MacroGenics, Inc., including a collaboration with Eli Lilly to conduct the first phase III clinical trial in early-onset type1 diabetes. After the initial Phase III trial conducted by Macrogenics failed to meet the primary endpoint, the drug was acquired by Provention Bio, which restarted development based on subset analysis of the original trials.

Society and culture

Legal status

In November 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Teizeild, intended for the treatment of type 1 diabetes. The applicant for this medicinal product is Sanofi Winthrop Industrie.

Research

Teplizumab has been used in clinical trials with the aim of protecting the remaining β-cells in people newly diagnosed with type1 diabetes. Immunomodulatory agents such as anti-CD3-antibodies may restore normal glucose control if provided in very early stages of the disease, such as stage 2 T1DM, when there are still enough beta cells to maintain euglycemia.

Teplizumab has been evaluated for treatment of renal allograft rejection, for induction therapy in islet transplant recipients, and for psoriatic arthritis.

A phase II study showed that teplizumab could delay the development of diabetes in family members of type 1 diabetics showing signs of progression towards diabetes by about two years after a single treatment, renewing interest in its use as a preventive rather than therapeutic treatment in high-risk patients.

A systematic review and meta-analysis, published in 2024, found that use of teplizumab is associated with better preservation of circulating C-peptide levels.

References

References

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5. (17 November 2022). "FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes".
6. American Diabetes Association Professional Practice Committee. (January 2022). "2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022". Diabetes Care.
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19. (November 2013). "Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders". Diabetes.
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22. (June 2005). "A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes". Diabetes.
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