FDA Approves Bayer’s Kerendia for Chronic Kidney Disease Linked to Type 1 Diabetes

Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved Kerendia (finerenone) for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D).

Kerendia is a non-steroidal mineralocorticoid receptor antagonist, or nsMRA. The new approval allows finerenone to be used to reduce the urinary albumin-to-creatinine ratio, also known as UACR, in adults with CKD linked to type 1 diabetes.

The approved doses are 10 mg and 20 mg.

According to Bayer, reducing UACR is expected to reduce the risk of continued decline in kidney function and end-stage kidney disease in this patient population.

The approval also makes Kerendia the first new FDA-approved treatment option in more than 30 years for adults with CKD associated with type 1 diabetes, according to the company.

Why This Approval Matters for People With Type 1 Diabetes

Type 1 diabetes is a chronic autoimmune disease in which the body's immune system destroys insulin-producing cells in the pancreas.

People with type 1 diabetes need insulin for the rest of their lives to control blood sugar.

Over time, diabetes can damage different organs, including the kidneys.

Around 30% of people with type 1 diabetes in the United States develop chronic kidney disease.

Once CKD develops, the risk of kidney failure and cardiovascular problems increases.

Even when patients receive recommended treatments to control blood sugar and blood pressure, some continue to experience kidney disease progression.

What Is Chronic Kidney Disease?

Chronic kidney disease happens when the kidneys become damaged and gradually lose their ability to work properly.

The kidneys normally filter waste and extra fluid from the blood.

Kidney disease can develop slowly, and many people do not notice clear symptoms during the early stages.

This makes CKD difficult to identify until the disease has already progressed.

In people with diabetes, kidney damage is one of the most common complications.

When CKD becomes severe, kidney function can decline to the point where a person develops end-stage kidney disease and may need dialysis or a kidney transplant.

UACR Is an Important Sign of Kidney Damage

One of the measurements used to monitor kidney damage is the urinary albumin-to-creatinine ratio, or UACR.

Albumin is a protein that normally remains in the blood. Healthy kidneys prevent large amounts of albumin from passing into the urine.

When the kidneys are damaged, more albumin can appear in the urine.

A higher UACR can therefore be a sign that the kidneys are being damaged.

The new Kerendia indication focuses on reducing UACR.

Bayer said the reduction is expected to help lower the risk of continued kidney function decline and end-stage kidney disease.

Kerendia Works by Blocking the Mineralocorticoid Receptor

Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist.

The mineralocorticoid receptor, or MR, is involved in several processes that can contribute to kidney and cardiovascular damage when it becomes overactivated.

MR overactivation can contribute to inflammation, fibrosis, and other harmful changes in tissues.

Finerenone works by blocking this receptor.

In simple terms, the medicine is designed to reduce some of the biological signals that can contribute to kidney damage and cardiovascular problems.

FINE-ONE Phase III Study Supported the Approval

The FDA approval was based on results from the Phase III FINE-ONE study.

FINE-ONE was a global, randomized, double-blind, placebo-controlled, multicenter clinical trial.

The study included 242 participants with chronic kidney disease and type 1 diabetes.

Patients were recruited from more than 80 sites across nine countries.

Participants received either finerenone or placebo once daily. They also continued to receive standard treatments for their diabetes and other health conditions.

Finerenone Reduced UACR in the Study

The main goal of FINE-ONE was to measure the relative change in UACR after six months of treatment.

Finerenone reduced UACR by 25% over six months compared with placebo.

The reduction was already visible earlier in the study.

At three months, UACR was reduced by 22% compared with placebo.

At six months, the reduction reached 28% compared with placebo.

These results supported the FDA's decision to approve finerenone for adults with CKD associated with type 1 diabetes.

More Patients Achieved a Meaningful UACR Reduction

Researchers also looked at how many patients achieved at least a 30% reduction in UACR at any point after baseline.

Among patients receiving finerenone, 68.1% achieved this level of reduction.

The corresponding figure for patients receiving placebo was 46.6%.

A 30% reduction in UACR has been identified by the American Diabetes Association as a threshold associated with slower CKD progression in people with CKD associated with type 2 diabetes.

Previous Phase III studies of finerenone in type 2 diabetes and CKD have also linked reductions in UACR of this size with a delay in kidney disease progression and fewer cardiovascular events.

Safety Results Were Consistent With Previous Data

The safety profile of finerenone in the FINE-ONE study was generally consistent with the safety information already available from studies in people with CKD associated with type 2 diabetes.

Finerenone has been studied in more than 20,000 patients across different populations with chronic kidney disease and heart failure.

The broader clinical experience has helped establish the safety and effectiveness profile of the medicine across different patient groups.

Kerendia Was First Approved in the US in 2021

Kerendia already has several approved uses in the United States.

The FDA first approved Kerendia in 2021 for adults with chronic kidney disease associated with type 2 diabetes.

In 2025, the medicine also received approval for adults with symptomatic chronic heart failure with a left ventricular ejection fraction of 40% or higher.

The latest approval adds adults with CKD associated with type 1 diabetes to its U.S. indication.

Bayer said the United States is currently the only country where finerenone is approved for CKD associated with type 1 diabetes.

Finerenone Is Already Approved in Many Countries

Finerenone is marketed as Kerendia and, in selected countries, as Firialta.

It is approved for adults with CKD associated with type 2 diabetes in more than 100 countries, including the United States, China, countries in Europe, and Japan.

Finerenone is also approved for certain adults with heart failure and a left ventricular ejection fraction of 40% or higher in the United States, Europe, Japan, China, and several other markets.

Bayer has also submitted applications for finerenone in non-diabetic CKD in China and Japan.

However, according to Bayer, finerenone is not currently approved anywhere for non-diabetic CKD.

Why CKD Is a Serious Problem in Type 1 Diabetes

Kidney disease can develop silently in people with type 1 diabetes.

One of the early signs can be an increase in albumin in the urine.

As kidney damage continues, kidney function can decline. This can be measured using estimated glomerular filtration rate, or eGFR.

eGFR provides an estimate of how well the kidneys are filtering blood.

When eGFR continues to decline, the risk of severe kidney disease increases.

Even with standard treatments such as ACE inhibitors and angiotensin receptor blockers, or ARBs, some people with CKD and type 1 diabetes continue to face a high risk of progression.

Bayer said up to one-quarter of people with this condition may progress to end-stage kidney disease.

CKD Also Raises Cardiovascular Risk

The problem is not limited to the kidneys.

Chronic kidney disease is also an independent risk factor for cardiovascular disease.

People with diabetes and CKD can therefore face increased risks of both kidney failure and cardiovascular complications.

This makes kidney protection an important part of long-term care for people with type 1 diabetes.

FDA Priority Review Came Before the Approval

The latest FDA decision followed an earlier regulatory milestone.

In May 2026, the FDA granted Priority Review designation to Bayer's supplemental New Drug Application for finerenone in adults with CKD associated with type 1 diabetes.

Priority Review is given to certain applications when the FDA determines that a medicine could provide an important improvement in treatment, subject to the agency's review standards.

The FDA has now completed that review and approved the expanded use of Kerendia.

Earlier Finerenone Studies Also Supported the Development

The FINE-ONE results were also supported by analyses from the Phase III FIDELIO-DKD and FIGARO-DKD studies.

Those studies evaluated finerenone in adults with CKD associated with type 2 diabetes.

According to Bayer, pooled analyses showed that more than 80% of finerenone's kidney benefit was explained by reductions in UACR.

These findings helped support the development of finerenone for people with type 1 diabetes and CKD.

What Doctors and Bayer Said

Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine in St. Louis and Co-Chair of the FINE-ONE study's Executive Committee, said people with CKD and type 1 diabetes have had limited treatment options for many years.

She said the approval of Kerendia provides another treatment option for this patient population.

Christine Roth, executive vice president of Global Product Strategy and Commercialization and a member of Bayer's Pharmaceuticals Leadership Team, said the U.S. approval expands treatment options for people with CKD associated with type 1 diabetes.

Bayer said the approval reflects its focus on developing treatments for cardiovascular and kidney diseases where significant medical needs remain.

Bayer Continues to Expand Its Kidney Disease Portfolio

Bayer has been developing medicines for cardiovascular, kidney, and cerebrovascular diseases.

The company's research includes treatments for conditions such as heart failure, cardiomyopathies, chronic kidney disease, and stroke.

Finerenone is one of the company's key medicines in this area.

The company said its broader research strategy focuses on biological targets and pathways that could change how cardiovascular and kidney diseases are treated.

What Happens Next for Kerendia?

Kerendia is now approved in the United States for three major patient groups: adults with CKD associated with type 2 diabetes, adults with symptomatic chronic heart failure with an LVEF of 40% or higher, and adults with CKD associated with type 1 diabetes.

For people with type 1 diabetes and CKD, the new indication focuses on reducing UACR with the expectation that this will help reduce the risk of kidney function decline and end-stage kidney disease.

The FDA approval gives doctors another option for managing the kidney complications associated with type 1 diabetes while Bayer continues to study finerenone across additional kidney and cardiovascular conditions.