FDA approves Bayer Kerendia as first new kidney disease therapy for type 1 diabetes in over 30 years

Chronic kidney disease remains one of the most serious complications of type 1 diabetes, and for more than three decades patients in the United States had no newly approved therapy designed specifically to slow the damage it causes. That changed on September 17, 2026, when the U.S. Food and Drug Administration approved Bayer's Kerendia (finerenone) for adults living with chronic kidney disease associated with type 1 diabetes. Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), a class of medicine that works by blocking a hormone pathway involved in inflammation and fibrosis in the kidney.

The new indication covers finerenone at 10 mg and 20 mg doses. It is intended to reduce the urinary albumin-to-creatinine ratio (UACR), a key marker of kidney damage, and the approval is expected to lower the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes. Bayer announced on September 17, 2026, that the regulator cleared the drug for this population, making it the first new treatment option for these patients in more than 30 years.

The decision did not arrive suddenly. In May 2026 the FDA granted Priority Review designation for Bayer's supplemental New Drug Application, a status reserved for therapies that could offer significant improvements over existing options. The agency's decision rests on the Phase III FINE-ONE study, whose results were published in the New England Journal of Medicine in March 2026 and 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. Pooled analyses from the earlier Phase III FIDELIO-DKD and FIGARO-DKD studies in CKD associated with type 2 diabetes supported the filing, with Bayer reporting that more than 80% of finerenone's kidney benefit was explained by reductions in UACR.

Finerenone is already familiar to physicians who treat kidney and heart disease. In the United States, Kerendia has been approved since 2021 for adults with CKD associated with type 2 diabetes, and since 2025 for adults with symptomatic chronic heart failure with left ventricular ejection fraction of 40% or greater. Internationally, the drug is marketed as Kerendia or, in selected countries, as Firialta, and is approved for CKD associated with type 2 diabetes in more than 100 countries, including China, Europe, Japan and the United States. With the September approval, the United States becomes the only country where Kerendia is cleared for CKD associated with type 1 diabetes.

Key Facts

Healio reported on September 17, 2026, that finerenone became the first drug approved for CKD associated with type 1 diabetes in more than 30 years, based on the Phase III FINE-ONE trial. In that study, adults who received 10 mg to 20 mg of once-daily finerenone had a 34% decrease in urinary albumin-to-creatinine ratio from baseline to 6 months, compared with a 12% reduction for the placebo group, a difference that produced a P value of .0001.

Pharmaceutical Executive reported on September 17, 2026, that FINE-ONE was a randomized, double-blind, placebo-controlled trial registered as NCT05901831. It enrolled 242 adults with CKD associated with type 1 diabetes and tested whether adding Kerendia, 10 mg or 20 mg once daily, to standard of care reduced UACR over six months. At month three, Kerendia reduced UACR relative to placebo by 22%, and at month six the reduction reached 28%.

Medscape reported on September 17, 2026, that the approval was informed not only by FINE-ONE but also by Phase III data from FIDELIO-DKD and FIGARO-DKD in adults with type 2 diabetes and CKD. The same report noted that approximately 20% to 30% of people in the United States with type 1 diabetes also have CKD. Bayer has cited that roughly 30% of an estimated 2 million U.S. patients with type 1 diabetes will develop CKD.

Safety findings were broadly consistent with earlier finerenone studies in type 2 diabetes. Pharmaceutical Executive reported on September 17, 2026, that treatment-emergent adverse events occurred in 47.1% of Kerendia patients versus 49.2% for placebo, while serious adverse events occurred in 11.8% of the Kerendia group versus 11.5% of placebo. Hyperkalemia, an adverse event of special interest, was observed more frequently with Kerendia at 10.1% versus 3.3% on placebo, and treatment discontinuation due to hyperkalemia was reported in 1.7% of Kerendia patients and none of the placebo group.

The European Pharmaceutical Review reported on September 17, 2026, that the approval was supported by data from three Phase III trials and that it authorizes the non-steroidal MRA for a third indication. In addition to the type 1 diabetes label, Kerendia is approved in the United States to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular disorders in adults with CKD associated with type 2 diabetes, and to reduce cardiovascular risk in heart failure patients with left ventricular ejection fraction of 40% or greater.

Analysis

The central significance of the decision is not merely that another drug has reached the market, but that an entire patient group has moved from a treatment vacuum into a regulated, evidence-backed option. Physicians treating type 1 diabetes have long relied on glucose control, blood pressure management and other standard measures to slow kidney damage, but they have lacked an FDA-approved therapy carrying an indication written specifically for this population. What this really means is that clinicians now have a labeled tool for a complication that until this month had no dedicated modern approval for more than three decades.

The evidence base is modest in size but consistent in direction. FINE-ONE randomized only 242 patients, and the trial measured UACR over six months rather than hard outcomes such as dialysis initiation or sustained eGFR decline. Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, wrote for Medscape in July 2026 that finerenone appears to work in patients with type 1 diabetes just as it works in patients with type 2 diabetes. She described the study as a great proof of concept while cautioning that long-term cardiovascular outcome data and eGFR data over time are not yet available, and she advised clinicians to watch serum potassium levels.

That caution is grounded in the trial numbers. Hyperkalemia appeared in 10.1% of patients on finerenone compared with 3.3% on placebo, though discontinuation because of the condition occurred in only 1.7% of treated patients. The overall adverse event profile was close to placebo, with treatment-emergent events at 47.1% versus 49.2% and serious events at 11.8% versus 11.5%. The bigger picture here is that a mechanism already validated in type 2 diabetes and heart failure has now been extended to type 1 diabetes, but the extension rests on a surrogate marker rather than on the long-term organ outcomes that would make the case airtight.

Bayer's own framing reflects that ambition. Dr Janet McGill, professor of medicine at Washington University School of Medicine in St. Louis and co-chair of the FINE-ONE executive committee, said the approval provides an important new treatment option for a population that has continued to face substantial unmet need. Dr Carolina Aldworth, Bayer's Executive Medical Director, said Kerendia's third indication validates the breadth of its clinical trial programme across cardiovascular and kidney diseases and helps a patient population that has historically been clinically underserved.

Why It Matters

For patients with type 1 diabetes and kidney disease, the practical change is the arrival of a once-daily oral therapy with a specific indication and a defined dosing range of 10 mg and 20 mg. The scale of the affected group is not trivial. Approximately 20% to 30% of people in the United States with type 1 diabetes also have CKD, and Bayer has estimated that about 30% of an estimated 2 million U.S. patients with type 1 diabetes will develop the condition. For a population that has waited more than 30 years for a new approved option, the label is itself a form of recognition.

The approval also reshapes the competitive and clinical landscape. Pharmaceutical Executive reported on September 17, 2026, that the decision establishes Kerendia as the only non-steroidal mineralocorticoid receptor antagonist indicated for adults with CKD associated with either type 2 diabetes or type 1 diabetes. That dual indication gives the drug a unique position among kidney therapies, and it may push clinicians to consider UACR reduction as a treatment target in type 1 diabetes more systematically than before.

There are limits worth stating plainly. FINE-ONE was a six-month study of a surrogate endpoint, and the reductions it measured were 22% at month three and 28% at month six relative to placebo. Longer follow-up, cardiovascular outcomes and kidney function trajectories over years will determine whether the early signal translates into fewer cases of end-stage kidney disease. Until then, the approval is best understood as an important opening rather than a finished story.

Next Up

Attention now turns to how quickly the type 1 diabetes indication is adopted in clinical practice and whether regulators outside the United States follow the FDA's lead. Bayer noted that the United States is currently the only country where Kerendia is approved for CKD associated with type 1 diabetes, even though the drug is cleared for CKD associated with type 2 diabetes in more than 100 countries, including China, Europe and Japan.

Researchers and clinicians will also be watching for longer-term data that go beyond UACR, including cardiovascular outcomes and eGFR trends, the very gaps that Anne L. Peters identified in July 2026. Until those results arrive, the FINE-ONE publication in the New England Journal of Medicine and its presentation at ASN Kidney Week 2025 will remain the reference points for a decision that ended a 30-year wait.