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Otelixizumab is a humanized, aglycosylated IgG1 monoclonal antibody that targets the CD3E component of the T cell receptor complex on all T cells. By binding to CD3E, it modulates T cell function—specifically inhibiting autoreactive effector T cells involved in autoimmune disease pathogenesis and promoting regulatory T cell pathways that foster immunological tolerance. Otelixizumab was primarily developed for type 1 diabetes but has also been investigated for other autoimmune diseases such as psoriasis, rheumatoid arthritis, Graves ophthalmopathy, multiple sclerosis, myasthenia gravis, and psoriatic arthritis. The drug was granted orphan drug status by the US FDA for type 1 diabetes mellitus. Despite reaching Phase III clinical trials in type 1 diabetes (DEFEND study), it failed to meet its primary efficacy endpoint and development in several indications has since been discontinued[1][2][4][6][9].
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