Based on the positive results of the Phase III FINEARTS-HF study, the European Union approved fenelone for patients with heart failure with a left ventricular ejection fraction (LVEF) ≥40%. The study included approximately 6,000 patients with various types and conditions of heart failure with LVEF ≥40%.

Fennellone is the first mineralocorticoid receptor antagonist to demonstrate definite cardiovascular benefits in a phase III clinical trial in patients with heart failure and LVEF ≥ 40%.

More than 15 million people in Europe suffer from heart failure, of whom about 50% have an LVEF ≥ 40%.

Currently, there are limited approved treatment options for this group that meet guideline recommendations, and the risk of cardiovascular events remains high.

On March 30, 2026, Bayer announced that the European Commission approved the selective nonsteroidal mineralocorticoid receptor antagonist fenelazor (Cosminda®) for the treatment of adult patients with heart failure with a left ventricular ejection fraction (LVEF) ≥40%, i.e., heart failure with mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). Within the EU, the indication for fenelazor (10 mg, 20 mg, 40 mg) has been expanded from its use in type 2 diabetes-related chronic kidney disease to the treatment of symptomatic chronic heart failure in adults with LVEF ≥40%.

Scott D. Solomon

Harvard Medical School professor

Chair of the FINEARTS-HF Research Executive Committee

MD

"The patient population with heart failure and a left ventricular ejection fraction ≥40% is large and continues to grow. They often have poor prognoses and face severe clinical challenges, including frequent hospitalizations due to worsening heart failure and a high risk of death. Fennellone can target the key pathogenic mechanism of heart failure—the overactivation of mineralocorticoid receptors. The FINEARTS-HF study has confirmed its efficacy. Fennellone is expected to become a new pillar of comprehensive treatment, improve the prognosis of this high-risk population, and meet long-standing unmet medical needs."

Heart failure is rapidly becoming a global public health problem, affecting more than 64 million people worldwide, with at least 15 million affected in Europe alone. Approximately half of these patients have an LVEF ≥ 40%. This type of heart failure is often accompanied by multiple comorbidities, such as chronic kidney disease, hypertension, and atrial fibrillation, leading to increased hospitalization and mortality rates. Currently, approved and guideline-recommended treatment options for these patients are limited, and they still face a high risk of cardiovascular events. Time trends indicate that this growing patient population will soon constitute the majority of hospitalized heart failure patients. Repeated hospitalizations are a major cause of heart failure-related medical costs, estimated at up to €29 billion annually in the EU.

Christine Roth

Executive Vice President of Global Product Strategy and Commercialization, Bayer Pharmaceuticals

"The EU approval of fenelazor for this new indication is excellent news for the millions of heart failure patients in Europe with LVEF ≥40%. We strive to make this important new treatment option available to all eligible patients, thereby improving their outcomes. The FINEARTS-HF study has already demonstrated that fenelazor is effective in reducing the combined risk of heart failure events and cardiovascular death, regardless of underlying treatment or patient characteristics. Five Phase III clinical trials involving over 20,000 patients with chronic kidney disease and heart failure have provided strong evidence highlighting the potential of fenelazor as a core therapy for heart failure and kidney disease with LVEF ≥40%."

The European Commission's approval is based on positive results from the pivotal Phase III FINEARTS-HF study. This study demonstrated that, on the basis of standard therapy, fenelazol significantly reduced cardiovascular death and total heart failure events (defined as hospitalization or emergency presentation for heart failure, including first and recurrent events) compared to placebo, with consistent benefit across different baseline therapies, comorbidities, and hospitalization statuses, including patient subgroups classified by ejection fraction or baseline use of SGLT-2 inhibitors. The FINEARTS-HF study results have been presented at the 2024 European Society of Cardiology Congress and simultaneously published in the *New England Journal of Medicine*. This study is part of the ongoing MOONRAKER project, one of the largest Phase III clinical trials in the field of heart failure to date, involving over 15,000 patients and aiming to comprehensively evaluate the efficacy of fenelazol across different patient populations and clinical settings.

Fennellone is a nonsteroidal selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) to demonstrate cardiovascular or renal benefits in five pivotal Phase III studies. These studies included patients with heart failure with a left ventricular ejection fraction (LVEF) ≥40%, patients with chronic kidney disease associated with type 2 diabetes, patients with chronic kidney disease associated with type 1 diabetes, and patients with non-diabetic chronic kidney disease. Fennellone was approved in the United States in July 2025 for the treatment of heart failure with an LVEF ≥40%, and subsequently approved for this indication in Japan, the European Union, and several other markets. Currently, marketing applications for this indication are under review in several countries, including China. Since 2021, fenelazone has been approved in more than 100 countries worldwide for the treatment of adult patients with chronic kidney disease associated with type 2 diabetes, including China, Europe, Japan, and the United States. In China, it is marketed under the brand name Keshenda®.

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