Written By: Pharmacally Medical News Desk
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved finerenone (Kerendia™) for the treatment of adults with chronic heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%, covering both mildly reduced (HFmrEF) and preserved ejection fraction (HFpEF). The decision introduces a new, evidence-based option for a large patient group that has historically had limited guideline-directed therapies.
The approval was announced by Bayer on December 22, 2025, and marks a key expansion of finerenone’s cardiovascular indications in Japan.
Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer, said the approval of finerenone in Japan fills a major treatment gap for patients with heart failure and LVEF ≥40%, a group at high risk of hospitalization and cardiovascular death. She highlighted that in the FINEARTS-HF study, finerenone delivered early, consistent, and sustained benefits across diverse patient profiles on top of existing therapies, supporting its potential to become a foundational treatment for heart failure care in Japan.
Heart failure remains a growing public health challenge in Japan’s aging population. Around 1.2 million people are currently living with HF nationwide, and roughly 60% have an LVEF ≥40%. These patients often have multiple comorbidities, including hypertension and atrial fibrillation, which increase the risk of hospitalization and cardiovascular death. Until now, approved and guideline-supported treatment options for this population were limited.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA). Unlike traditional MRAs, it selectively targets harmful overactivation of the mineralocorticoid receptor pathway, which is known to drive inflammation, fibrosis, and adverse cardiac remodelling. Importantly, finerenone is the first therapy targeting the MR pathway to demonstrate statistically significant and clinically meaningful cardiovascular benefits in patients with HF and LVEF ≥40% in a Phase III trial.
Clinical evidence: FINEARTS-HF
The Japanese approval is based on positive results from the Phase III FINEARTS-HF study. The trial was presented at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in the New England Journal of Medicine.
FINEARTS-HF was a randomized, double-blind, placebo-controlled, global Phase III study that enrolled nearly 6,000 patients across 37 countries. It evaluated finerenone versus placebo on top of usual therapy in symptomatic HF patients (NYHA class II–IV) with LVEF ≥40%.
The study met its primary endpoint, showing a statistically significant reduction in the composite of cardiovascular death and total heart failure events, including first and recurrent hospitalizations or urgent HF visits. Benefits were consistent across background therapies, comorbidities, and hospitalization status.
Guideline support in Japan
Finerenone’s approval aligns with its strong positioning in the 2025 joint guidelines from the Japanese Circulation Society (JCS) and the Japanese Heart Failure Society (JHFS). In these guidelines, finerenone is the only MRA to receive a Class IIa recommendation for the treatment of HF with LVEF ≥40%.
The 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 the landmark FIDELIO-DKD and FIGARO-DKD trials. This positioning is consistent with recommendations from European guidelines.
Broader development program and global status
Finerenone is already approved in more than 95 countries for chronic kidney disease associated with type 2 diabetes and is also approved for HF with LVEF ≥40% in the United States. Additional regulatory reviews for this HF indication are ongoing in regions including the EU and China.
Finerenone’s cardiovascular benefits in heart failure build on its established renal protection, with earlier Phase III data FINE-ONE Trial also showing a significant reduction in albuminuria in adults with chronic kidney disease, including patients with diabetes, further highlighting its broad cardiorenal impact.
The FINEARTS-HF trial is part of Bayer’s extensive MOONRAKER heart failure program, which includes more than 15,000 patients across multiple Phase III and investigator-sponsored studies. Together, these trials aim to define finerenone’s role across a broad spectrum of heart failure phenotypes and clinical settings.
With MHLW approval, finerenone becomes a new therapeutic option for a large and underserved group of Japanese heart failure patients. By targeting the mineralocorticoid receptor pathway and demonstrating clear cardiovascular benefit, finerenone has the potential to become a foundational therapy for HF with preserved or mildly reduced ejection fraction in Japan.
References
Finerenone approved in Japan for treatment of patients with chronic heart failure, 22 December 2025, https://www.bayer.com/media/en-us/finerenone-approved-in-japan-for-treatment-of-patients-with-chronic-heart-failure/