Teplizumab

USDailyMed:Teplizumab A10XX01(WHO) CA:℞-only/Schedule DUS:℞-onlyEU:Rx-only 876387-05-2 DB06606 none S4M959U2IJ D09013 Teplizumab, sold under the brand nameTzieldamong others, is an anti-CD3humanized monoclonal antibodythat is the first approved treatment indicated to delay the onset of stage 3type1 diabetesin people with stage 2 type1 diabetes. Teplizumab's mechanism of action involves binding toCD3protein complexes (a molecule involved in recognising antigens and activating T cells) on the surface ofT-cellsand modifying T-cell immune behaviour to reducecytotoxicity.This appears to involve weak agonistic activity on signaling via the T cell receptor-CD3 complex associated with the development of anergy, unresponsiveness, and/or apoptosis, particularly of unwanted activatedT effector cells. In addition, regulatory cytokines are released and regulatory T cells are expanded that may lead to the reestablishment of immune tolerance.To avoid overly stimulating cytokine release, theFc regionof this antibody has been engineered to haveFc receptornon-binding (FNB) properties. Teplizumab was approved for medical use in the United States in November 2022,and in the European Union in January 2026.The USFood and Drug Administration(FDA) considers it to be afirst-in-class medication.