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%.
- Kerendia is indicated to reduce the risk of:
- sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM).
- cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. - Kerendia works by blocking mineralocorticoid receptor (MR) mediated sodium reabsorption and MR overactivation in the tissues of the kidney, heart, and blood vessels. MR overactivation is thought to contribute to fibrosis and inflammation.
- Kerendia tablets are taken once daily with or without food.
- Warnings and precautions associated with Kerendia include hyperkalemia and worsening of renal function in patients with heart failure.
- Adverse reactions occurring in ≥ 1% of patients on Kerendia and more frequently than placebo include hyperkalemia, hypotension, and hyponatremia.
Development timeline for Kerendia
Further information
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