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Rilzabrutinib is an investigational **oral small-molecule, reversible covalent Bruton's tyrosine kinase inhibitor** being developed by Sanofi, originally from Principia Biopharma. It is designed to selectively inhibit BTK in immune cells including B cells and macrophages, with the goal of reducing pathogenic autoantibody production and Fc receptor-mediated inflammatory signaling while potentially limiting off-target toxicities seen with earlier BTK inhibitors. The most advanced program is in **immune thrombocytopenia**, where phase 3 LUNA 3 data showed durable platelet responses and improvements in bleeding and fatigue; the drug has also been studied in other immune-mediated diseases including **asthma**, **chronic spontaneous urticaria**, **warm autoimmune hemolytic anemia**, **atopic dermatitis**, **prurigo nodularis**, and **IgG4-related disease**. In published and trial data, common adverse events have included diarrhea, nausea, and headache, with an overall safety profile generally described as favorable for the BTK class.
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