Bayer Kerendia Wins FDA Approval for Kidney Disease in Type 1 Diabetes

Bayer said on September 17, 2026, that the U.S. Food and Drug Administration has approved Kerendia (finerenone), a selective non-steroidal mineralocorticoid receptor antagonist, for the treatment of adult patients with chronic kidney disease associated with type 1 diabetes. Under the new indication, finerenone, sold in 10 mg and 20 mg doses, is indicated to reduce the urinary albumin-to-creatinine ratio, or UACR, which is expected to reduce the risk of sustained estimated glomerular filtration rate decline and end-stage kidney disease in adults with the condition, according to Bayer’s announcement.

The company characterized Kerendia as the first FDA-approved treatment option in more than 30 years for adults with chronic kidney disease associated with type 1 diabetes. The decision marks the third approved U.S. indication for the drug, following its 2021 approval for chronic kidney disease associated with type 2 diabetes and its 2025 approval for symptomatic chronic heart failure with left ventricular ejection fraction of at least 40%.

In May 2026, the FDA granted Priority Review designation to Bayer’s supplemental New Drug Application for finerenone in the type 1 diabetes population. Bayer said the approval is based on positive results from the pivotal Phase III FINE-ONE study, supported by the totality of evidence, including pooled analyses from the Phase III FIDELIO-DKD and FIGARO-DKD studies in chronic kidney disease associated with type 2 diabetes. Those analyses showed that more than 80% of finerenone’s kidney benefit was explained by reductions in UACR, according to the company.

FINE-ONE Phase III Results

FINE-ONE was a global, randomized, placebo-controlled, double-blind, multicenter Phase III study in people with chronic kidney disease and type 1 diabetes. The trial randomized 242 participants from more than 80 sites across nine countries to receive either finerenone or placebo once daily, with patients also receiving usual therapy to treat symptoms and comorbidities.

According to Bayer, finerenone in addition to standard of care significantly reduced the primary endpoint of relative change in UACR by 25% over six months compared with placebo. The UACR reduction with finerenone was 22% at Month 3 and 28% at Month 6 relative to placebo. At any time following baseline, 68.1% of participants receiving finerenone achieved a UACR reduction of at least 30%, compared with 46.6% of those receiving placebo. Bayer noted that a 30% reduction in UACR is a threshold established by the American Diabetes Association as associated with slower chronic kidney disease progression in patients with chronic kidney disease and type 2 diabetes, and that reductions of this magnitude in prior Phase III studies in adults with type 2 diabetes were associated with a delay in kidney disease progression and a reduction in cardiovascular events. The safety profile of finerenone in FINE-ONE was largely consistent with the existing body of evidence in adults with chronic kidney disease associated with type 2 diabetes, the company said.

The FINE-ONE results were published in the New England Journal of Medicine in March 2026 and were presented in November 2025 as a “Featured High-Impact Clinical Trial” during the opening plenary session of the American Society of Nephrology’s Kidney Week, according to the release.

“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression,” said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis and Co-Chair of the study’s Executive Committee. “The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of the Pharmaceuticals Leadership Team at Bayer, said: “Today’s approval in the U.S. marks an important advance for people living with chronic kidney disease associated with type 1 diabetes—a serious and often under-recognized condition. As the first new FDA-approved treatment option in more than 30 years for this patient population, Kerendia reflects Bayer’s commitment to addressing significant unmet needs and bringing meaningful new treatment options to patients.”

Mechanism, Disease Burden and Global Status

Finerenone is a selective non-steroidal mineralocorticoid receptor antagonist that has been shown to block the harmful effects of mineralocorticoid receptor overactivation, which Bayer said contributes to chronic kidney disease progression and cardiovascular damage that can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. The company said finerenone has been studied in more than 20,000 patients across multiple populations with chronic kidney disease and/or heart failure, and that it is the first drug targeting the mineralocorticoid receptor pathway to demonstrate heart and/or kidney benefits in five pivotal Phase III studies across a broad range of patient populations.

Bayer cited estimates that approximately 30% of people with type 1 diabetes in the U.S. develop chronic kidney disease, increasing their risk of kidney failure and cardiovascular events. Crude 2018 estimates indicated that 1.4 million U.S. adults aged 20 or older, or 5.2% of U.S. adults with diagnosed diabetes, reported both having type 1 diabetes and using insulin, according to the release. The 2017 global prevalence of chronic kidney disease due to type 1 diabetes was an estimated 32.5 per 100,000 individuals. Despite guideline-recommended treatment with ACE inhibitors and angiotensin receptor blockers, residual risk remains high in people with chronic kidney disease and type 1 diabetes, with up to a quarter progressing to end-stage kidney disease, the company said. It added that blood glucose intervention targeting HbA1c levels of 7% or lower can slow the onset and progression of kidney disease in people with type 1 diabetes, and that chronic kidney disease is a leading cause of death in type 1 diabetes.

Since 2021, finerenone has been marketed as Kerendia or, in selected countries, as Firialta, and it is approved for the treatment of adults with chronic kidney disease associated with type 2 diabetes in more than 100 countries, including China, Europe, Japan, and the U.S. It is also approved for heart failure with left ventricular ejection fraction of at least 40% in the U.S., Europe, Japan, China, and several other markets. Applications for marketing authorization in non-diabetic chronic kidney disease have been filed in China and Japan, and finerenone is not approved for non-diabetic chronic kidney disease in any country. With the new FDA decision, the U.S. is the only country where Kerendia is approved for the treatment of adults with chronic kidney disease associated with type 1 diabetes.