Kerendia cleared for chronic kidney disease in adults with type 1 diabetes — first new treatment in 30 years

What this means

Chronic kidney disease (CKD) affects the ability of the kidneys to filter waste and excess fluid from the blood, and if it progresses far enough it can lead to kidney failure and the need for dialysis or transplant. About one in five to one in three Americans with type 1 diabetes will develop CKD, and until now no drug had been specifically approved to slow that progression in the T1D population for more than three decades. KERENDIA (finerenone) is Bayer's once-daily pill in a distinct class called nonsteroidal mineralocorticoid receptor antagonists — it blocks a hormone receptor that drives kidney inflammation and scarring while carrying a different tolerability profile than older steroidal MRAs like spironolactone. On September 16, 2026 the FDA approved a supplemental application extending KERENDIA's label from CKD in adults with type 2 diabetes (originally approved in 2021) to now include adults with CKD associated with type 1 diabetes. The expansion is supported by the Phase 3 FINE-ONE trial, which was published in the New England Journal of Medicine in March 2026 and showed KERENDIA lowered the urinary albumin-to-creatinine ratio (UACR) — a validated marker of kidney damage that predicts long-term decline in kidney function — versus placebo. The size of the effect is expected to translate into slower loss of kidney function and reduced risk of progressing to end-stage kidney disease over time.