Bayer Preps Kerendia CKD Label Expansion

By: Editorial Team

March 16, 2026


  • Company: Bayer AG
  • Location: Germany (global pharma)
  • Headline figures: FIND-CKD met primary endpoint; delayed CKD progression
  • Focus area: Non-diabetic chronic kidney disease (CKD)
  • Next steps: Regulatory filings for label expansion

What happened?

Bayer announced positive topline results from the Phase III FIND-CKD study on 15 March 2026, showing finerenone (Kerendia) met its primary endpoint of delaying CKD progression versus placebo in patients with non-diabetic CKD. The largest trial to date in this population (NCT05047263) spanned diverse CKD aetiologies like hypertension and glomerulonephritis.

Why does it matter?

Kerendia is currently approved for CKD associated with type 2 diabetes (T2D), but non-diabetic CKD affects millions more; a label expansion would substantially broaden access to this non-steroidal mineralocorticoid receptor antagonist, addressing unmet need in earlier disease stages and diverse causes where few disease-modifying options exist.

Who’s behind it?

Bayer’s Pharmaceuticals Division leads Kerendia development, building on FIDELIO-DKD and FIGARO-DKD successes in diabetic CKD. The MOONRAKER programme now extends to non-diabetic populations, positioning Kerendia as a cardiorenal-metabolic staple.

How was it achieved?

FIND-CKD randomised over 1,500 patients to finerenone 10/20 mg or placebo atop standard care (RAS inhibitors). Finerenone significantly slowed eGFR decline, with consistent safety (primarily hyperkalaemia management). Study complements prior data in >15,000 CKD patients.

What’s next?

Bayer plans regulatory submissions for non-diabetic CKD indication, targeting FDA and EMA. Full results for peer-reviewed publication; integration into CKD guidelines could follow if approved, expanding Kerendia’s market amid cardiorenal focus.

What are people saying?

Bayer: “Significant step forward… largest Phase III study to date focused on non-diabetic CKD.” Analysts: “Positions finerenone for blockbuster status beyond diabetes.”

More News From: