FDA Accepted New Use for Kidney Disease Drug
The application seeks approval for KERENDIA to treat chronic kidney disease in adults without diabetes.
Updated on Oct. 8, 2026 in Diabetes
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The FDA has accepted Bayer’s supplemental new drug application to expand the use of KERENDIA for patients with chronic kidney disease (CKD) who do not have diabetes. This potential new indication follows findings from the FIND-CKD trial, which evaluated the drug in 1,584 adults.
Why it matters
Treatment advances for kidney disease have historically centered on patients with concurrent type 2 diabetes, leaving a gap for those without that diagnosis. Expanding access to therapies like KERENDIA could offer a new management option for millions of Americans with CKD.
In the Phase 3 FIND-CKD trial of 1,584 adults, KERENDIA demonstrated a statistically significant improvement in eGFR slope and a reduction in composite kidney-cardiovascular outcomes compared to placebo. Hyperkalemia occurred in 17% of the treatment group versus 13.3% for placebo.
The players
FDA
The federal agency responsible for regulating pharmaceuticals and ensuring the safety and efficacy of medical treatments in the United States.
Bayer
A global life sciences company that develops pharmaceuticals, including KERENDIA, for cardiovascular and renal conditions.
KERENDIA
A non-steroidal mineralocorticoid receptor antagonist used to manage kidney and cardiovascular risk factors.
The details
Participants in the trial received KERENDIA or a placebo in addition to background standard of care, which included maximally tolerated doses of an ACE inhibitor or an ARB. KERENDIA works to mitigate kidney and cardiovascular risk in these patients, though clinical monitoring for hyperkalemia is required as the drug affects potassium regulation. The trial noted an overall treatment-emergent adverse event rate of 68.3% in the KERENDIA arm and 65.4% in the placebo group.
Timeline
2021: KERENDIA was approved for CKD associated with type 2 diabetes.
July 2025: The drug was approved for heart failure treatment.
September 2026: The drug was approved for CKD with type 1 diabetes.
October 8, 2026: The FDA accepted the supplemental new drug application.
Health Landscape
The potential approval of KERENDIA for patients without diabetes represents an effort to diversify treatment beyond the standard-of-care reliance on ACE inhibitors or ARBs. This development aligns with the historical arc of renal medicine, which is shifting toward specialized therapies for broader CKD cohorts.
If you are managing chronic kidney disease without diabetes, discuss with your doctor whether emerging treatment options may align with your current care plan. Be aware that medications targeting kidney function often require regular monitoring of potassium levels, a topic worth raising during your next checkup.
The takeaway
The FDA is currently reviewing a new potential use for KERENDIA that could benefit those with kidney disease who do not have diabetes. Patients should keep track of their kidney function tests and consult their physician regarding whether recent therapeutic updates are relevant to their specific diagnosis.
Further reading
For more on managing kidney health, visit our Diabetes section.
More information
Learn more about the therapy and its clinical trials at the Bayer pharmaceutical information portal.
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