FDA Accepted Bayer Application for Kerendia
The FDA has accepted a supplemental application for Kerendia to treat chronic kidney disease in patients without diabetes.
Updated on Oct. 8, 2026 in Diabetes
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The FDA accepted Bayer's supplemental new drug application to expand the use of Kerendia to adults with chronic kidney disease who do not have diabetes. This follows the drug's previously approved indications for managing conditions related to type 1 and type 2 diabetes and heart failure.
Why it matters
Treatment options for chronic kidney disease have historically been centered on patients with concurrent type 2 diabetes. This expansion could broaden the available therapies for the approximately 37 million adults in the U.S. currently living with chronic kidney disease.
In the FIND-CKD trial, Kerendia showed a statistically significant improvement in eGFR slope and a lower risk of composite kidney-cardiovascular outcomes compared to placebo. Hyperkalemia occurred in 17% of patients receiving the medication, compared to 13.3% in the placebo group.
The players
FDA
The Food and Drug Administration is the federal agency responsible for regulating pharmaceuticals and medical devices in the United States.
Bayer
Bayer is a multinational pharmaceutical and life sciences company that reported 45.6 billion euros in fiscal 2025 sales.
The details
The application is supported by findings from the FIND-CKD trial, where participants received Kerendia or a placebo alongside standard care involving ACE inhibitors or ARBs. While the treatment showed efficacy, 68.3% of the Kerendia group experienced treatment-emergent adverse events, compared to 65.4% in the placebo arm.
Timeline
2021: Kerendia was approved for chronic kidney disease with type 2 diabetes.
July 2025: Kerendia received approval for heart failure treatment.
September 2026: Kerendia gained approval for chronic kidney disease with type 1 diabetes.
October 8, 2026: The FDA officially accepted the supplemental new drug application.
Health Landscape
This application follows the FIND-CKD trial, which serves as the foundational clinical evidence for the proposed indication expansion. The development marks a departure from standard treatment protocols that have previously restricted similar therapeutic interventions to patients with diabetes.
Patients currently living with chronic kidney disease but lacking a diabetes diagnosis may gain a new treatment option if the FDA approves this application. Those considering the medication should consult their physician regarding the risk of hyperkalemia and their specific medical history.
The takeaway
Advancements in chronic kidney disease research are increasingly addressing patient groups that fall outside traditional diabetes-linked categories. Patients should maintain open communication with healthcare providers to stay informed about new treatment possibilities and potential side effects.
Further reading
For more information on current treatment standards, visit the Diabetes section.
More information
For more details on clinical data, visit the Bayer pharmaceutical information portal.
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