In September 2026, the US FDA approved finerenone (brand name Kerendia, made by Bayer) for adults with chronic kidney disease (CKD) associated with type 1 diabetes. Bayer announced the decision on September 16, 2026. It is the first new drug approved for this group in more than 30 years, according to the company.

Key takeaways

  • Kerendia is a once-daily tablet from a class called nonsteroidal mineralocorticoid receptor antagonists.
  • The US approval is to lower urinary albumin-to-creatinine ratio (UACR), a marker of kidney damage, in adults with CKD linked to type 1 diabetes.
  • It was already approved in the US for CKD associated with type 2 diabetes (2021) and for certain types of heart failure (2025).
  • It is a prescription medicine. Whether it is appropriate is a decision for you and your kidney or diabetes care team.

What was approved, and where

This is a US FDA decision, made through a priority review of a supplemental application. The approved wording focuses on lowering UACR in adults with CKD associated with type 1 diabetes. Bayer says the expected benefit is a lower risk of sustained decline in kidney function and of end-stage kidney disease. That longer-term benefit has not yet been shown directly in people with type 1 diabetes.

Why kidney health matters in type 1 diabetes

Over many years, high glucose can damage the small blood vessels in the kidneys. Reports citing the company estimate that roughly 20% to 30% of people in the US with type 1 diabetes also have CKD. Early kidney damage often causes no symptoms, which is why doctors check urine albumin and blood creatinine (used to estimate eGFR) on a regular schedule.

What the FINE-ONE trial found

The approval is based on FINE-ONE, a phase 3, randomized, double-blind, placebo-controlled trial of 242 adults with type 1 diabetes and CKD. Participants took finerenone (10 mg or 20 mg daily) or placebo on top of standard care. Compared with placebo, finerenone lowered UACR by about 22% at month 3 and 28% at month 6, as reported by HCPLive from the company data.

Overall side effect rates were similar between groups. The main difference was high blood potassium (hyperkalemia): 10.1% with finerenone versus 3.3% with placebo, and 1.7% of people on finerenone stopped treatment because of it. For this reason, potassium and kidney function blood tests are part of monitoring.

The caveats worth knowing

  • Surrogate marker. The trial measured albuminuria, not kidney failure itself. Independent experts quoted in the coverage noted the trial was small and short, and that long-term kidney and heart benefits in type 1 diabetes are still unknown.
  • Not for everyone. Medicines in this class are not suitable for every kidney, potassium or medication profile. Only a prescriber who knows your history can say.
  • One tool among several. Blood pressure control, glucose management and regular kidney testing remain the foundation of kidney protection.

What this means for you

If you live with type 1 diabetes, this news is mostly a reminder to know your numbers. Consider asking your care team:

  • When was my last UACR and eGFR test, and what were the results?
  • How often should I be tested?
  • Is this new option relevant to me, and what monitoring would it need?

Day-to-day habits still matter. Keeping glucose in range, staying active and keeping blood pressure in check all support kidney health. The DiaFitus app helps you log workouts and see how they relate to your glucose, and the guide to diabetes and exercise covers how to move safely. Check with your care team before changing your exercise routine if you have kidney disease.

DiaFitus is an educational app and is not affiliated with Bayer. This article is general information, not medical advice, and does not recommend any medication.