Bayer has secured approval in Japan for finerenone (Kerendia), marking a major expansion of treatment options for patients with chronic heart failure and left ventricular ejection fraction (LVEF) of 40% or higher. 

 

Japan’s Ministry of Health, Labour and Welfare (MHLW) cleared the non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) for adults with mildly reduced or preserved ejection fraction—groups that represent the majority of heart failure patients.

 

Heart failure is a fast-growing global health crisis, affecting more than 64 million people worldwide, and Japan’s aging population is accelerating the burden.

 

“The approval of finerenone in Japan helps to address a major gap in heart failure care: the high rates of cardiovascular events such as hospitalization for heart failure or cardiovascular death in the large and growing group of patients with heart failure with left ventricular ejection fraction of ≥40%,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. 

 

“In the FINEARTS-HF study, finerenone showed early, consistent and sustained efficacy across a range of patient profiles and in addition to existing treatments. We are enthusiastic about the potential of finerenone to emerge as a foundational therapy addressing the substantial needs of these patients in Japan.”

 

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients with LVEF ≥40% in a Phase III trial. Already marketed as Kerendia—or Firialta in some countries—the drug is approved in more than 95 countries for chronic kidney disease associated with type 2 diabetes, including Japan, the U.S., Europe, and China. It is also approved in the US for heart failure with LVEF ≥40%.

 

The drug’s position in Japan is further strengthened by the newly released 2025 joint guidelines from the Japanese Circulation Society and the Japanese Heart Failure Society. Finerenone is the only mineralocorticoid receptor antagonist to receive a Class IIa recommendation for treating heart failure with LVEF ≥40%.

 

MHLW approval was based on results from the Phase III FINEARTS-HF study, unveiled at the ESC Congress 2024 and published in The New England Journal of Medicine. 

 

The trial showed finerenone significantly reduced the combined risk of cardiovascular death and total heart failure events—including first and recurrent hospitalizations and urgent visits—on top of standard therapy. Benefits were consistent across background treatments, comorbidities, and hospitalization status.