Bayer’s Kerendia Wins FDA Approval for Type 1 Diabetes

Bayer announced on September 17, 2026, that the U.S. FDA approved Kerendia (finerenone) for adults with chronic kidney disease associated with type 1 diabetes.

The approval makes Kerendia the first FDA-approved treatment option in more than 30 years specifically for this patient population, according to Bayer.

The approval is based largely on the Phase III FINE-ONE trial, in which finerenone reduced urine albumin-to-creatinine ratio by 25% over six months versus placebo when added to standard care.

The new indication is intended to reduce albuminuria, a marker associated with progression toward declining kidney function and end-stage kidney disease.

Kerendia is now approved for three U.S. uses:
type 1 diabetes–associated CKD, type 2 diabetes–associated CKD, and heart failure with a left-ventricular ejection fraction of at least 40%.

Approximately 30% of people with type 1 diabetes in the United States develop chronic kidney disease, highlighting the size of the unmet medical need.

Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist. Clinicians will need to monitor safety issues such as elevated potassium levels, a known concern with this drug class.