The U.S. Food and Drug Administration has approved Bayer’s Kerendia (finerenone) for a third indication, chronic kidney disease associated with type 1 diabetes, marking the first new treatment option for this specific patient population in more than 30 years. The approval, granted following Priority Review of Bayer’s supplemental New Drug Application, extends finerenone’s label beyond its existing chronic kidney disease and heart failure indications and represents the first approved therapy for type 1 diabetes-associated kidney disease anywhere in the world.
What Changes for Patients With Type 1 Diabetes
The approval fills a gap that has persisted for decades in kidney disease care. Sodium-glucose cotransporter-2 inhibitors, or SGLT2 inhibitors, already carry approved kidney disease indications for patients with type 2 diabetes, but they have never gained a comparable role in type 1 diabetes-associated chronic kidney disease, largely because of an increased risk of diabetic ketoacidosis in people with type 1 diabetes. That gap has left clinicians with limited pharmacological options specifically tailored to slowing kidney disease progression in this population, a fact Bayer and independent researchers both point to as the reason this approval is being described as filling a genuine unmet medical need rather than simply adding another treatment alternative.
“People with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression.”
— Dr. Janet McGill, Washington University School of Medicine
How Finerenone Works and What It’s Approved to Do
Finerenone is a non-steroidal mineralocorticoid receptor antagonist, a drug class that works by blocking overactivation of the mineralocorticoid receptor, a pathway implicated in inflammation and fibrosis that contributes to kidney and cardiovascular damage in patients with diabetes. In this newly approved indication, finerenone is specifically approved to reduce urinary albumin-to-creatinine ratio, or UACR, a standard clinical marker of kidney damage, dosed as a once-daily oral tablet at either 10 or 20 milligrams added on top of a patient’s existing standard of care.
It’s worth being precise about what that approval actually rests on. The FDA cleared finerenone based on its ability to reduce UACR itself, a surrogate endpoint, with the drug’s label stating that this reduction is “expected to” translate into reduced risk of sustained kidney function decline and end-stage kidney disease, a bridging approach grounded in the relationship between UACR and hard clinical outcomes already established in finerenone’s earlier type 2 diabetes kidney trials, rather than direct trial evidence of reduced kidney failure specifically in this type 1 diabetes population.
The Clinical Evidence Behind the Approval
The approval was supported primarily by the Phase III FINE-ONE trial, a global, randomized, double-blind, placebo-controlled study that enrolled 242 adults with chronic kidney disease associated with type 1 diabetes. The trial’s primary objective was determining whether adding once-daily finerenone to standard of care outperformed placebo in reducing UACR over six months, and the results, published in the New England Journal of Medicine in March 2026, showed UACR reductions of up to 28 percent at that six-month mark. The FDA’s review also drew on supporting data from the earlier FIDELIO-DKD and FIGARO-DKD trials, both of which studied finerenone in chronic kidney disease associated with type 2 diabetes and helped establish the broader UACR-to-outcomes relationship underpinning this newer approval.
Kerendia’s Growing Label
This marks finerenone’s third approved indication in the U.S. since its initial 2021 approval for chronic kidney disease associated with type 2 diabetes, which covered reduced risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death, heart attack, and heart failure hospitalization in that population. Bayer secured a second indication in July 2025, when the FDA approved finerenone for heart failure with mildly reduced or preserved left ventricular ejection fraction.
“Kerendia’s third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases.”
— Carolina Aldworth, Executive Medical Director, Bayer
What’s Next for Bayer’s Kidney Disease Pipeline
Bayer’s ambitions for finerenone extend further still. The drug sits within the company’s broader THUNDERBALL clinical development program, which also includes the FIND-CKD trial studying finerenone in non-diabetic chronic kidney disease, a trial that met its primary endpoint in March 2026. That result could position Bayer to pursue a fourth approved indication, potentially extending finerenone’s reach to kidney disease patients without diabetes altogether, a population considerably larger than either of the diabetes-specific groups the drug currently serves.
For now, this week’s approval gives adults with type 1 diabetes-associated chronic kidney disease their first new dedicated treatment option in over three decades, closing a gap in kidney disease care that had persisted even as treatment options expanded substantially for the more common type 2 diabetes population over the same period.
This article is for general informational purposes and does not constitute medical advice. Patients with chronic kidney disease and type 1 diabetes should discuss treatment options with their physician.