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Kerendia FDA Approval History

Last updated by Judith Stewart, BPharm on July 14, 2025.

FDA Approved: Yes (First approved July 9, 2021)
Brand name: Kerendia
Generic name: finerenone
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Chronic Kidney Disease, Heart Failure

Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) used in the treatment of chronic kidney disease associated with type 2 diabetes, and heart failure with left ventricular ejection fraction ≥40%.

Development timeline for Kerendia

DateArticle
Jul 14, 2025Approval U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review
Jul  9, 2021Approval FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
Nov  9, 2020Bayer Submits Regulatory Applications for Investigational Drug Finerenone in the U.S. and the EU for Patients with Chronic Kidney Disease and Type 2 Diabetes
Jul  9, 2020Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

Further information

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