Bayer recently announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone), a selective, non-steroidal Mineralocorticoid Receptor Antagonist (nsMRA), for the treatment of adult patients with Chronic Kidney Disease (CKD) associated with Type 1 Diabetes (T1D).

Finerenone (10mg, 20mg) is now indicated to reduce Urinary Albumin-to-Creatinine Ratio (UACR), which is expected to reduce the risk of sustained estimated Glomeruar Filtration Rate (eGFR) decline and end-stage kidney disease in adults with CKD associated with T1D.

Approximately, 30 percent of people with T1D in the US develop CKD, increasing their risk of kidney failure and cardiovascular events. Even with recommended treatments for blood glucose and blood pressure management, many patients remain at risk of kidney disease progression and cardiovascular complications.

Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee, said, “For more than 3 decades, people with Chronic Kidney Disease and Type 1 Diabetes have had limited options to address the risk of kidney disease progression. 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.”

In May 2026, the FDA granted Priority Review (PR) designation for Bayer’s supplemental New Drug Application (sNDA) for finerenone for the treatment of adult patients with CKD associated with T1D. The approval of finerenone by the FDA is based on the positive results of the phase 3 FINE-ONE study, which were published in the New England Journal of Medicine in March 2026 and presented in November 2025 as “Featured High-Impact Clinical Trial” during the Opening Plenary session of the American Society of Nephrology’s (ASN) Kidney Week.

These findings are supported by pooled analyses from the phase 3 FIDELIO-DKD and FIGARO-DKD studies in CKD associated with Type 2 Diabetes (T2D), showing that over 80 percent of finerenone's kidney benefit was explained by reductions in UACR.

Christine Roth, Executive Vice President, Global Product Strategy and Commercialisation, and Member, Pharmaceuticals Leadership Team, Bayer, said, “Today’s approval in the US marks an important advance for people living with Chronic Kidney Disease associated with Type 1 Diabetes—a serious and often under-recognised 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.”

In the US, Kerendia has been approved since 2021 for the treatment of adult patients with CKD associated with Type 2 Diabetes (T2D), since 2025 for the treatment of adult patients with symptomatic chronic heart failure with Left Ventricular Ejection Fraction (LVEF) ≥ 40 percent, and now for the treatment of adult patients with CKD associated with T1D.