Breakthrough T1D applauds today’s approval by the U.S. Food and Drug Administration (FDA) of the drug finerenone (Kerendia™/Firialta™) as the first new therapy that can treat chronic kidney disease (CKD) associated with type 1 diabetes (T1D) in 30 years. Finerenone reduces urinary albumin-to-creatinine ratio (UACR) in adults with CKD and T1D, which has been shown to slow CKD progression. It is a once-daily pill that has been approved since 2021 for CKD associated with type 2 diabetes and, since July 2025, for certain adults with heart failure.
CKD is one of the most common complications of T1D. Nearly a third of people living with T1D will develop CKD, increasing the risk of both kidney failure and cardiovascular disease. Right now, the treatment options for people with T1D and CKD are limited, and there is a major need for therapies that can address this. Advancing treatments like finerenone that can improve the lives of those living with T1D is core to Breakthrough T1D’s mission.
“Today there are few treatments available for chronic kidney disease, a common complication of type 1 diabetes. The approval of finerenone is a huge win for the T1D community,” said Jonathan Rosen, Ph.D., Breakthrough T1D Research Director. “Breakthrough T1D thanks the FDA for its review and approval and Bayer for their commitment to giving people with T1D a new therapeutic option for chronic kidney disease.”
Breakthrough T1D collaborated strategically with Bayer to support the FINE-ONE phase 3 clinical trial behind this approval and continues to support multiple clinical trials focused on kidney and heart disease in people with T1D to close the gap in available therapy options.
