In mid-September 2026, the U.S. FDA approved finerenone (brand name Kerendia, made by Bayer) for adults with chronic kidney disease (CKD) associated with type 1 diabetes. Bayer describes it as the first new FDA-approved treatment option for this group in more than 30 years.

Key takeaways

  • This is a U.S. approval announced by Bayer in September 2026. It adds type 1 diabetes to an indication Kerendia already had for type 2 diabetes (approved in 2021).
  • The approval is based on the phase 3 FINE-ONE trial, which looked at a kidney marker called UACR, not at kidney failure.
  • It is a prescription medicine. Whether it fits a person is a decision for their kidney or diabetes care team.

What was approved?

Kerendia is a once-daily tablet from a class called non-steroidal mineralocorticoid receptor antagonists. According to reports on the approval, the new label is for adults with CKD associated with type 1 diabetes, with the aim of lowering urine albumin-to-creatinine ratio (UACR). UACR is a urine test that shows how much albumin, a protein, is leaking through the kidneys. Higher levels are an early sign of kidney damage.

What did the FINE-ONE trial show?

FINE-ONE was a phase 3, placebo-controlled trial in people with type 1 diabetes and CKD. Published results, reported in the New England Journal of Medicine, showed that people taking finerenone had a larger drop in UACR over six months than those taking placebo. Coverage describes this as roughly a 25% greater reduction than placebo. Rates of side effects and serious side effects were reported as similar between the two groups.

It is important to be clear about what the trial measured. UACR is a marker. The trial was not designed to show whether finerenone prevents kidney failure or heart events in type 1 diabetes. Expectations of slower CKD progression are based on a lower UACR and on earlier experience in type 2 diabetes, so longer-term data will matter.

Why does this matter for people with type 1 diabetes?

Kidney disease is one of the long-term complications of diabetes, and for people with type 1 diabetes the treatment options specific to it have been limited. A new approved option gives care teams one more tool to discuss. That is the real news here: choice, not a cure.

What this means for you

  • Get your kidneys checked. Guidelines generally recommend regular urine albumin and blood creatinine (eGFR) tests for people with diabetes. Ask your care team how often is right for you.
  • Do not start or change medicines on your own. Kerendia can affect potassium levels, and it is not right for everyone. Your doctor will decide whether it suits you and what monitoring you need.
  • Keep the basics going. Blood pressure, glucose management and regular movement all support kidney and heart health. Our guide on why moving matters so much covers the exercise side, always with your care team's advice on safety.

Looking ahead

This approval applies to the United States. Other regions follow their own regulators, so availability elsewhere may differ. As more real-world experience builds, expect more detail on who benefits most. For other recent regulatory news, see our roundup on weekly insulin and a cleared dosing app.

This article is for general education and is not medical advice. DiaFitus is not affiliated with Bayer or any manufacturer named. Talk to your doctor or diabetes care team about your own treatment.