teplizumab   Click here for help

GtoPdb Ligand ID: 12252

Synonyms: humanized OKT3 | MGA031 | PRV-031 | teplizumab-mzwv | Tzield®
Approved drug Immunopharmacology Ligand
teplizumab is an approved drug (FDA (2022))
Compound class: Antibody
Comment: Teplizumab is a humanized anti-CD3e monoclonal antibody that was originally developed as an immunomodulatory agent. Structurally it is a modified version of the mouse antibody muromonab-CD3 (mOKT3) that has been used to reverse steroid-resistant renal allograft rejection. Alterations in the OKT3 CH2 domain disrupt Fcγ receptor binding, and blocks antibody-mediated effector cells functions and cytokine release [5,7]. It was advanced to extended clinical evaluations for potential to protect pancreatic β-cells in newly diagnosed type 1 diabetes (T1D) patients [4,6], following evidence that it impaired expansion of alloreactive anti-β cell T cells [5], and that a single short course of teplizumab treatment could induce a long-lasting improvement in patients' C-peptide responses and clinical parameters (including preservation of insulin production) in the early stages of T1D [2-3].
No information available.
Summary of Clinical Use Click here for help
Early clinical evidence indicated a propensity towards preventive efficacy in individuals at risk of developing type 1 diabetes [1]. Approved in 2022 to delay the onset of stage 3 type 1 diabetes. was investigated for anti-inflammatory activity in moderate to severe psoriasis, but injection site reactions lead to termination in this disease.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT00954915 Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis Phase 1/Phase 2 Interventional MacroGenics
NCT04598893 Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab Observational Provention Bio, Inc.
NCT03875729 Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab Phase 3 Interventional Provention Bio, Inc.
NCT00920582 Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus Phase 3 Interventional MacroGenics
NCT01030861 Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" Phase 2 Interventional National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 8