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Kerendia FDA Approval History

Last updated by Judith Stewart, BPharm on July 13, 2021.

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 Associated with Type 2 Diabetes

Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

  • Kerendia is indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
  • Kerendia works by blocking overactivation of the mineralocorticoid receptor (MR). Mineralocorticoid receptor overactivation is thought to contribute to fibrosis and inflammation which can contribute to permanent structural kidney damage.
  • Kerendia tablets are taken once daily with or without food.
  • The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia. Serum potassium levels should be monitored.
  • Common adverse reactions include hyperkalemia (high potassium levels), hypotension (low blood pressure), and hyponatremia (low sodium levels).

Development timeline for Kerendia

DateArticle
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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