Bayer’s Kerendia has secured a third FDA approval, becoming the first new therapeutic advance for chronic kidney disease linked to type 1 diabetes in more than three decades.
The US regulator approved finerenone, sold as Kerendia, for reducing urinary albumin-to-creatinine ratio, a key marker expected to slow kidney disease progression in adults with CKD associated with type 1 diabetes.
The agency granted Priority Review to Bayer’s supplemental New Drug Application, reflecting the significant unmet medical need within this historically underserved patient population.
Kerendia is now the only mineralocorticoid receptor antagonist indicated for adults with CKD associated with either type 1 or type 2 diabetes, cementing its position as a unique treatment option.
The newly approved regimen involves a once-daily oral dose of either 10 mg or 20 mg finerenone, administered in addition to existing standard-of-care treatments for affected patients.
The approval was supported by the FINE-ONE trial, a global, randomised, double-blind, placebo-controlled phase 3 study enrolling 242 adult participants with CKD associated with type 1 diabetes.
Trial data showed that adding finerenone to standard care produced a 28% reduction in urinary albumin-to-creatinine ratio over six months compared to placebo, meeting the study’s primary objective.
Supporting evidence was also drawn from the phase 3 FIDELIO-DKD and FIGARO-DKD trials, which assessed finerenone in adults with CKD associated with type 2 diabetes.
Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that blocks harmful effects of mineralocorticoid receptor overactivation, which drives kidney disease progression and cardiovascular damage.
Unlike older steroidal agents such as spironolactone and eplerenone, finerenone’s nonsteroidal structure offers higher receptor selectivity and a more balanced kidney-to-cardiac tissue distribution, reducing unwanted hormonal side effects.
Approximately 20 to 30 percent of people in the United States living with type 1 diabetes also have chronic kidney disease, placing them at serious risk of kidney failure and disease progression.
SGLT2 inhibitors, which carry approved CKD indications for type 2 diabetes populations, have not gained a comparable role in type 1 diabetes-associated CKD, partly due to elevated diabetic ketoacidosis risks in those patients.
“Kerendia’s third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved,” said Carolina Aldworth, MD, MSc, executive medical director at Bayer.
This latest approval builds on Kerendia’s 2021 approval for CKD associated with type 2 diabetes and a separate heart failure approval covering patients with left ventricular ejection fraction of 40% or greater.
Bayer’s broader THUNDERBALL chronic kidney disease programme also includes the FIND-CKD trial in non-diabetic CKD, which met its primary endpoint in March 2026, potentially supporting a further label expansion for Kerendia.