Kerendia (Finerenone): Heart Failure and CKD Landscape

Finerenone, sold by Bayer as Kerendia, is a non-steroidal mineralocorticoid receptor antagonist (MRA) used in kidney and heart conditions. As of November 4, 2026 it carries approvals in chronic kidney disease (CKD) with diabetes and in heart failure, and sales are growing quickly, which makes it a useful case for how a drug’s label can expand across cardiology and nephrology.

Mechanism at a glance

Finerenone is described in its trial publications as a non-steroidal, selective mineralocorticoid receptor antagonist. It blocks the receptor for aldosterone, a hormone involved in salt retention and in inflammation and scarring of the heart and kidneys. The characteristic safety issue is high potassium: in FIDELIO-DKD, hyperkalemia-related discontinuation was 2.3% on finerenone versus 0.9% on placebo (NEJM abstract via Europe PMC).

Why it matters

Three pivotal results underpin the label. FIDELIO-DKD (5,734 patients with CKD and type 2 diabetes) reported a kidney composite hazard ratio of 0.82. FIGARO-DKD (7,437 patients) reported a cardiovascular composite hazard ratio of 0.87, driven mainly by fewer hospitalizations for heart failure. FINEARTS-HF (6,001 patients with heart failure and ejection fraction of 40% or more) reported a rate ratio of 0.84 for total worsening heart failure events plus cardiovascular death, with no clear difference in cardiovascular death alone (hazard ratio 0.93; 95% CI 0.78 to 1.11) (NEJM abstract via Europe PMC).

Competitive pressure points

• Steroidal MRAs: SPIRIT-HF, presented at ACC.26, found no significant benefit of spironolactone in 730 patients with mildly reduced or preserved ejection fraction (rate ratio 1.32; 95% CI 0.79 to 2.21); investigators called it underpowered, so it neither confirms nor refutes the class (TCTMD).
• SGLT2 inhibitors: the FDA broadened the empagliflozin heart failure indication in February 2022 (AJMC) and extended dapagliflozin across the ejection fraction range (TCTMD). The CONFIRMATION-HF trial tests finerenone with empagliflozin in hospitalized patients (ClinicalTrials.gov).
• Balcinrenone/dapagliflozin (AstraZeneca): the Phase 3 BalanceD-HF trial (NCT06307652) lists 3,850 planned patients and is recruiting, with primary completion estimated for April 2027 (ClinicalTrials.gov).
• Vicadrostat (Boehringer Ingelheim): on September 15, 2026 the company discontinued EASi-KIDNEY for lack of expected benefit when added to empagliflozin; the EASi-HF Reduced, EASi-HF Preserved and EASi-PROTKT trials continue (HCPLive).

What to watch

• The FDA decision on finerenone in CKD without diabetes (FIND-CKD); no action date was found.
• Hospitalized heart failure studies (REDEFINE-HF, CONFIRMATION-HF) and FINALITY-HF in patients who cannot take steroidal MRAs.
• Whether EASi-HF data change views on aldosterone-pathway combinations.
• Price and reimbursement debates, such as a 2026 cost-effectiveness analysis that found finerenone not cost-effective at US prices over the trial horizon (Europe PMC).

For related context, see our heart failure trial activity note and the guide to cardiovascular competitive intelligence.

Recent developments

Updated November 4, 2026. Items are drawn from company announcements, regulators and trade press; links go to the sources.

• Nov 3, 2026: Bayer’s Q3 statement lists Kerendia sales of 374 million euros versus 221 million a year earlier (up 69.2% reported, 64.9% adjusted for currency and portfolio effects), and 977 million euros for nine months versus 565 million. Bayer cites higher volumes in the US and China. (Bayer)
• Oct 2026: The FDA accepted a supplemental application for finerenone in adults with CKD without diabetes, based on the Phase III FIND-CKD study (reported by a German financial site on October 10). (Boerse Global)
• Sep 17, 2026: Bayer announced FDA approval of Kerendia to reduce UACR, expected to lower the risk of sustained eGFR decline and end-stage kidney disease, in adults with CKD associated with type 1 diabetes, after priority review. In FINE-ONE (242 adults), placebo-adjusted UACR reductions were 22% at month 3 and 28% at month 6; hyperkalemia occurred in 10.1% versus 3.3%. (Pharmaceutical Executive)
• May 22, 2026: China’s NMPA approved Kerendia for symptomatic chronic heart failure with LVEF of 40% or more. (Boerse Express)
• Mar 16, 2026: Bayer announced that FIND-CKD (more than 1,500 adults with non-diabetic CKD) met its primary endpoint, a statistically significant improvement in eGFR slope; no effect size was given in the coverage we read. (ConsultantLive)
• Jul 14, 2025: The FDA approved Kerendia for adults with heart failure and LVEF of 40% or more, per Bayer’s announcement as reported in trade coverage. (Drugs.com)

Upcoming catalysts

• Nov 7-9, 2026: AHA Scientific Sessions, Chicago; we did not find a finerenone presentation in the late-breaking list.
• April 2027 (estimated): primary completion of AstraZeneca’s BalanceD-HF.
• November 2027 (estimated): primary completion listed for REDEFINE-HF (5,200 planned) and CONFIRMATION-HF (1,500 planned), both recruiting. (ClinicalTrials.gov)
• FINALITY-HF: still recruiting 2,600 planned patients, with primary completion listed as August 2026 (estimated) in a record last updated July 10, 2026, so the date looks out of date. (ClinicalTrials.gov)

Bottom line

Kerendia has moved from a diabetes-kidney drug to one with heart failure and type 1 diabetes kidney labels, and a non-diabetic CKD filing under review. The competition is now less about whether MRAs work and more about combinations with SGLT2 inhibitors and rival aldosterone-pathway drugs, where Boehringer Ingelheim’s discontinuation of EASi-KIDNEY is a reminder that not every combination pays off.

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This article is for informational and competitive-intelligence purposes only and is not medical advice. Approvals, labels and trial results change; verify details against current prescribing information and primary sources.