FDA Expands Tzield Approval to Children as Young as One
Sanofi announced that the FDA has expanded approval of Tzield for children as young as one year old with stage 2 type 1 diabetes, with the goal of delaying the onset of stage 3 type 1 diabetes. The approval was announced April 22, 2026. Read Sanofi’s announcement.
Stage 2 type 1 diabetes means the autoimmune process is already underway, with two or more type 1 diabetes-related autoantibodies and abnormal blood sugar levels. Stage 3 is the clinical diagnosis most families recognize: high blood sugars, symptoms, and the need for daily insulin therapy.
Tzield is not a cure. It does not prevent type 1 diabetes forever. But it may delay the start of stage 3, and for families with very young children, time to prepare can matter.
The approval was supported by data from the PETITE-T1D study in children under eight with stage 2 type 1 diabetes. Tzield is given as an IV infusion once daily for 14 consecutive days. View the PETITE-T1D study.
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