Breakthrough T1D Celebrates Approval of Tzield for use in Stage 3 Type 1 Diabetes in the US

NEW YORK, June 12, 2026 /PRNewswire/ -- Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today's decision from the U.S. Food and Drug Administration (FDA) to approve Tzield for use in individuals ages 8-17 within eight weeks of a stage 3 T1D diagnosis. Stage 3 T1D occurs when the body can no longer produce enough insulin on its own to manage blood sugars and insulin therapy is required. A T1D diagnosis usually occurs in this stage, and the FDA's decision marks the first approval of a disease-modifying therapy for stage 3 T1D.

The PROTECT study showed Tzield preserved beta cell function in individuals with stage 3 T1D and delayed further disease progression. Tzield was approved in 2022 as the first disease-modifying therapy for use in stage 2 T1D and remains the first and only disease-modifying therapy available in T1D.

"The approval of Tzield for individuals ages 8-17 with stage 3 type 1 diabetes is an exciting milestone that reinforces the importance of beta cell preservation and provides an opportunity to change the course of the disease for those living with T1D," said Aaron J. Kowalski, Ph.D., Breakthrough T1D CEO. "For the first time, individuals diagnosed with type 1 diabetes in stage 3 will have the option to treat the disease rather than just the symptoms. Breakthrough T1D thanks the FDA for recognizing the urgent unmet need in T1D and granting Tzield accelerated approval. We are also grateful for Sanofi's continued study of Tzield, and we look forward to the results of the confirmatory clinical research."

Study of Tzield in this patient population is ongoing through Sanofi's confirmatory BETA-PRESERVE study, which will provide more information on the drug in the coming years. As the first FDA-approved therapy for stage 3 T1D, Tzield also charts a regulatory path forward for the many disease-modifying therapies in the T1D pipeline that rely on C-peptide as a clinical trial endpoint.

Breakthrough T1D has supported the evolution of Tzield for decades, including contributions through research grants, federal funding through the Special Diabetes Program, a strategic investment by the T1D Fund into Provention Bio, which was developing the drug prior to acquisition by Sanofi in 2023, and more. Breakthrough T1D will continue to work so that individuals across the globe in stage 3 T1D have more therapy options.

About Breakthrough T1D, Formerly JDRF
As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.

About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

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SOURCE Breakthrough T1D, Formerly JDRF