Finerenone Approved in Japan for Chronic Heart Failure Treatment, reports Bayer

Regulatory approval and patient population
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with chronic heart failure (HF) and left ventricular ejection fraction (LVEF) of ≥40%. The indication covers patients with mildly reduced (HFmrEF) and preserved ejection fraction (HFpEF), groups for which treatment options have historically been limited.

Heart failure represents a growing public health challenge in Japan’s ageing population. Approximately 1.2 million people in the country are living with HF, and around 60% have an LVEF of at least 40%, placing them at elevated risk of cardiovascular hospitalization and mortality.

Clinical evidence supporting the decision
The approval is based on positive results from the Phase III FINEARTS-HF study, which evaluated finerenone in patients with HF and LVEF ≥40%. In this study, finerenone demonstrated a statistically significant and clinically meaningful reduction in the composite endpoint of cardiovascular death and total heart failure events, including first and recurrent hospitalizations or urgent HF visits, compared with placebo on top of standard therapy.

Benefits were observed consistently across patient subgroups, irrespective of background treatments, comorbidities, or hospitalization status. The results were presented at ESC Congress 2024 and published simultaneously in the New England Journal of Medicine.

Mechanism and therapeutic relevance
Finerenone targets the mineralocorticoid receptor (MR) pathway, which plays a central role in inflammation and fibrosis associated with cardiovascular and renal disease. It is the first therapy in this class to demonstrate cardiovascular benefit in a Phase III trial specifically in patients with HF and LVEF ≥40%.

The drug is already approved in multiple regions for chronic kidney disease associated with type 2 diabetes and has also received approval for HF with LVEF ≥40% in the United States.

Position in Japanese clinical guidelines
In the 2025 joint Guidelines on the Diagnosis and Treatment of Heart Failure issued by the Japanese Circulation Society (JCS) and the Japanese Heart Failure Society (JHFS), finerenone is the only mineralocorticoid receptor antagonist to receive a Class IIa recommendation for the treatment of HF with LVEF ≥40%. The same guidelines also assign finerenone a Class I recommendation with Level A evidence for prevention of heart failure in patients with type 2 diabetes and chronic kidney disease, based on data from the Phase III FIDELIO-DKD and FIGARO-DKD studies.

Broader development programme
The FINEARTS-HF study forms part of the broader MOONRAKER Phase III clinical programme, which includes more than 15,000 patients across multiple heart failure populations. The programme aims to characterise the role of finerenone across a wide range of clinical settings and disease severities.

Bayer, which developed finerenone, stated that the Japanese approval addresses a major unmet need in heart failure care by expanding guideline-directed therapy options for patients with preserved or mildly reduced ejection fraction.

www.bayer.com