Bayer announced plans to present extensive new clinical data from its KERENDIA (finerenone) program at two major medical conferences in 2025, showcasing the expanding evidence base for this non-steroidal mineralocorticoid receptor antagonist across cardiovascular and renal indications.
Major Data Presentations at ACC.25
The pharmaceutical company will present 13 new analyses from the KERENDIA clinical trial program at the American College of Cardiology 74th Annual Scientific Session & Expo 2025 in Chicago from March 29-31, 2025. Ten presentations will feature new data from the pivotal Phase III FINEARTS-HF cardiovascular outcomes trial, which investigated KERENDIA for treating adult patients with heart failure with a left ventricular ejection fraction of ≥40%.
The FINEARTS-HF subgroup analyses will examine finerenone's efficacy and safety across various patient populations, including those with different kidney risk levels, New York Heart Association functional classes, and comorbid conditions such as atrial fibrillation, chronic obstructive pulmonary disease, and anemia. Additional presentations will explore biomarker changes, including effects on N-terminal pro-B-type natriuretic peptide and bilirubin levels.
Combination Therapy and Real-World Evidence
At the European Renal Association 62nd Congress in Vienna from June 4-7, 2025, Bayer will present results from the CONFIDENCE trial, which assessed the combination of finerenone with empagliflozin in participants with chronic kidney disease and type 2 diabetes. The presentations will also include sub-analyses from FINEARTS-HF examining finerenone's effects on estimated glomerular filtration rate slope, albuminuria, and cardiovascular outcomes.
The ACC.25 program will feature real-world research on patients with worsening heart failure within a large healthcare delivery system from 2012-2021, providing insights into clinical practice patterns and outcomes beyond controlled trial settings.
Comprehensive Clinical Evidence
Additional analyses include the FINE-HEART trial, an integrated pooled analysis across three pivotal Phase III clinical trials with finerenone: FINEARTS-HF, FIDELIO-DKD, and FIGARO-DKD. A post-hoc analysis of FIDELITY, which pooled data from FIDELIO-DKD and FIGARO-DKD trials, will evaluate the long-term effects of KERENDIA on cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes.
Current Therapeutic Applications
KERENDIA is currently approved by the U.S. Food and Drug Administration to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes. The drug was initially approved in July 2021.
Safety Profile and Monitoring Requirements
From pooled data of two placebo-controlled studies, the most common adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%). The drug requires careful monitoring of serum potassium levels, with treatment contraindicated if serum potassium exceeds 5.0 mEq/L at initiation.
The comprehensive data presentations at both conferences represent Bayer's continued investment in expanding the evidence base for finerenone across multiple therapeutic areas, potentially supporting future regulatory submissions and clinical practice guidelines.
