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Teplizumab is a humanized anti-CD3 monoclonal antibody indicated to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and older with stage 2 type 1 diabetes. It works by binding to CD3, a cell surface antigen present on T lymphocytes (CD4+ and CD8+), which are involved in the autoimmune destruction of pancreatic beta cells. The mechanism involves partial agonistic signaling and deactivation of autoreactive T lymphocytes targeting beta cells, leading to an increase in regulatory T cells and exhausted CD8+ T cells. This immunomodulatory effect helps preserve endogenous insulin production by delaying disease progression. Teplizumab was developed as the first approved therapy for this indication.
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