Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Start Date28 Feb 2025

Sponsor / Collaborator

Bayer AG

CTR20250562

/ RecruitingNot Applicable

非奈利酮片在健康受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验

[Translation] An open, randomized, crossover bioequivalence study of finerenone tablets in healthy subjects under fasting/fed conditions

主要试验目的：研究空腹/餐后状态下单次口服受试制剂非奈利酮片（规格：10mg）与参比制剂非奈利酮片（商品名：可申达®/Kerendia®；规格：10mg；Bayer AG 生产）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要试验目的：评估受试制剂非奈利酮片（规格：10mg）与参比制剂非奈利酮片（商品名：可申达®/Kerendia®，规格：10mg）在健康受试者中的安全性。

[Translation]

The primary objective of the study was to study the pharmacokinetics of a single oral dose of the test preparation finerenone tablets (specification: 10 mg) and the reference preparation finerenone tablets (trade name: Kerendia®/Kerendia®; specification: 10 mg; manufactured by Bayer AG) in healthy subjects in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. The secondary objective of the study was to evaluate the safety of the test preparation finerenone tablets (specification: 10 mg) and the reference preparation finerenone tablets (trade name: Kerendia®/Kerendia®, specification: 10 mg) in healthy subjects.

Start Date25 Feb 2025

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

100 Clinical Results associated with Finerenone

100 Translational Medicine associated with Finerenone

100 Patents (Medical) associated with Finerenone

574

Literatures (Medical) associated with Finerenone

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of finerenone therapy for patients with chronic kidney disease and type 2 diabetes in England & Wales: results of the FINE-CKD model

Article

Author: Folkerts, Kerstin ; Roy-Chaudhury, Prabir ; Mernagh, Paul ; Levy, Pierre ; Pochopień, Michał ; Drzewiecka, Aleksandra ; Sullivan, Sean D. ; Cherney, David ; Millier, Aurélie ; Morris, Stephen

OBJECTIVE:

Chronic kidney disease (CKD) is the leading cause of kidney failure, end-stage kidney disease (ESKD), and cardiovascular (CV) events in patients with type 2 diabetes (T2D). The FIDELIO-DKD trial demonstrated that finerenone lowered the risk of renal and CV events in patients with CKD and T2D, regardless of cardiovascular disease history. This study evaluated the cost-effectiveness of finerenone added to background treatment (finerenone + BT) versus background treatment (BT) alone in patients with CKD and T2D from the perspective of the National Health Service in England and Wales.

METHODS:

A lifetime Markov model assessed the indicated usage of finerenone for the treatment of stage 3 or 4 CKD with albuminuria associated with T2D in adults, as per the relevant marketing authorization. The model structure considered kidney disease progression and CV risk, with health states encompassing patients' kidney disease stage and CV event profiles, using patient-level data from the FIDELIO-DKD trial. Model outcomes were life years, quality-adjusted life years (QALYs), per-patient costs, incremental costs, and incremental cost-effectiveness ratio (ICER). Sensitivity and scenario analysis were performed, including an analysis exploring the impact of real-world data which suggests more frequent sodium-glucose co-transporter-2 (SGLT2) inhibitor use in the United Kingdom since FIDELIO-DKD.

RESULTS:

Patients receiving finerenone experienced kidney and CV benefits, including reduced rates of nonfatal CV events and CV deaths, translating to improvements in survival and quality-adjusted life years (QALYs) of 6.11 and 5.97 per patient for finerenone + BT versus BT, respectively. Total discounted per-patient costs were £48,940 for finerenone + BT and £47,716 for BT alone, resulting in an incremental cost-effectiveness ratio of £8,808 per QALY gained for finerenone + BT versus BT.

CONCLUSION:

Sensitivity and scenario analyses, including more frequent SGLT2 inhibitor use consistent with real-world data, indicate a robust ICER that remains within the bounds of what is typically considered cost-effective.

01 Mar 2025·AMERICAN JOURNAL OF MEDICINE

Chlorthalidone as Secondary Treatment in HFpEF?

Review

Author: Gelfman, Daniel M. ; Gelfman, Daniel M

This review addresses important issues that face practitioners today concerning the treatment of heart failure with preserved ejection fraction (HFpEF). It points out how the accepted efficacy of HFpEF medication treatment has changed. Medications are now recommended for use in HFpEF that have diuretic properties and are significant because of a reduction in the frequency of the development of heart failure (not mortality). This heart failure incidence reduction appears predictable and is valuable, but it raises the question of the use of chlorthalidone in the treatment of HFpEF. Chlorthalidone has previously been demonstrated to reduce heart failure incidence in the treatment of hypertensive patients, which is a similar patient population. Chlorthalidone, possibly with a generic mineralocorticoid antagonist, could be an acceptable low-cost alternate therapy as secondary treatment for HFpEF. Of course, chlorthalidone does not have the other theoretic benefits of the sodium-glucose cotransporter 2 (SGLT2) inhibitors or finerenone. It would be helpful if this was discussed in the upcoming HFpEF guidelines, especially for use in patients who cannot afford or tolerate the new HFpEF medications.

08 Feb 2025·European Heart Journal-Cardiovascular Pharmacotherapy

Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone—a FIDELITY analysis

Article

Author: Filippatos, Gerasimos ; Pecoits-Filho, Roberto ; Anker, Stefan D ; Greenberg, Barry ; Rossing, Peter ; Ruilope, Luis ; Pitt, Bertram ; Lawatscheck, Robert ; Scalise, Andrea ; Herzog, Charles A ; Lambelet, Marc ; Agarwal, Rajiv

Abstract:

Aims:

Hypokalaemia is associated with cardiovascular events and mortality in patients with chronic kidney disease (CKD). This exploratory FIDELITY analysis, a prespecified pooled patient-dataset from FIDELIO-DKD and FIGARO-DKD, investigated the incidence and effect of hypokalaemia in patients with CKD and type 2 diabetes (T2D) treated with finerenone vs. placebo.

Methods and results:

Outcomes include the incidence of treatment-emergent hypokalaemia (serum potassium <4.0 or <3.5 mmol/L) and the effect of finerenone on cardiovascular composite outcome (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure) and arrhythmia composite outcome (new diagnosis of atrial fibrillation/atrial flutter, hospitalization due to arrhythmia, or sudden cardiac death) by baseline serum potassium subgroups. In the FIDELITY population, treatment-emergent hypokalaemia with serum potassium <4.0 and <3.5 mmol/L occurred in 41.1% and 7.5%, respectively. Hazards of cardiovascular and arrhythmia composite outcomes were higher in patients with baseline serum potassium <4.0 vs. 4.0–4.5 mmol/L [hazard ratio (HR) 1.16; 95% confidence interval (CI) 1.02–1.32, P = 0.022 and HR 1.20; 95% CI 1.00–1.44, P = 0.055, respectively]. Finerenone reduced the incidence of hypokalaemia with serum potassium <4.0 mmol/L (HR 0.63; 95% CI 0.60–0.66) and <3.5 mmol/L (HR 0.46; 95% CI 0.40–0.53) vs. placebo. Finerenone lessened the hazard of cardiovascular and arrhythmia events vs. placebo, irrespective of baseline serum potassium.

Conclusion:

A substantial proportion of patients with CKD and T2D experienced hypokalaemia, which was associated with an increased hazard of adverse cardiovascular outcomes. Finerenone reduced the incidence of hypokalaemia. Finerenone reduced the hazard of cardiovascular and arrhythmia outcomes irrespective of serum potassium subgroups.Clinical trials registration: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).

News (Medical) associated with Finerenone

06 Feb 2025

·www.fiercepharma.com

Nephrologists already aboard GLP-1 bandwagon, providing launchpad for Ozempic in CKD: Spherix

Despite growth in the use of GLP-1s to treat chronic kidney disease, Spherix said SGLT2 inhibitors remain the cornerstone of CKD treatment. Nephrologists jumped on the GLP-1 bandwagon well before Novo Nordisk won FDA approval for Ozempic in chronic kidney disease (CKD), according to Spherix Global Insights.The FDA expanded Ozempic’s label last week, clearing Novo to market the drug for use in adult Type 2 diabetes patients who also have CKD. But Spherix’s analysis of data from more than 1,000 non-dialysis CKD charts shows nephrologists were turned on to the potential for GLP-1 drugs to benefit their patients even before the agency gave Novo the greenlight in the population.Endocrinologists and primary care physicians have historically been the main prescribers of GLP-1 drugs, Spherix said, but nephrologists are an increasingly important source of new scripts. Spherix’s assessment shows treatment rates in the analyzed CKD population nearly doubled from 2023 to 2024.The rise covers a period in which the promise of Ozempic in CKD became clear. Novo stopped a phase 3b trial of semaglutide, the active ingredient in Ozempic, early for efficacy in October 2023 and shared data from the trial in March 2024. While the analysis suggests Novo has begun to make inroads in CKD, Spherix said SGLT2 inhibitors remain the cornerstone of the treatment arsenal in that space. The use of SGLT2 inhibitors has risen in recent years as leading therapies such as AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance have secured expanded labels that cover the non-diabetic CKD population.But Spherix said some prescribers are still cautious about SGLT2 inhibitors, particularly in people without diabetes, because of “lingering concerns over perceived benefits.” Similarly, the market intelligence firm said “hesitancy” about the benefits of Bayer’s mineralocorticoid receptor antagonist Kerendia is a barrier to growth of that drug in CKD. Safety, and notably instances of high potassium, is also an issue for Kerendia, Spherix said.Many of the same products featured in GlobalData’s recent analysis of the heart failure market. The report tipped demand for GLP-1 drugs, SGLT2 inhibitors and Kerendia to help add $20 billion to the value of the market in 10 years.

Phase 3Drug Approval

03 Feb 2025

·pipelinereview.com

Bayer files for approval of finerenone in heart failure in the EU

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced or preserved LVEF Regulatory submission is based on positive data from the Phase III FINEARTS-HF study presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine Approximately 60 million people worldwide are living with HF, including an estimated 15 million people in the EU Half of these patients suffer from HF with a LVEF of ≥40%, which is associated with substantial morbidity and mortality; however, limited approved and guideline-directed treatments are currently available BERLIN, Germany I February 3, 2025 I Bayer today announced the submission of a marketing authorization application to the European Medicines Agency (EMA), seeking approval in the EU for the use of finerenone in adult patients with HF with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of ≥40% in the Phase III study FINEARTS-HF.Finerenone is already marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. “Treating heart failure with an LVEF of 40% or greater poses unique challenges, leaving patients with few effective therapeutic options,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, finerenone has the potential to become a new pillar in addressing this common form of heart failure, offering hope for improved outcomes in a patient population that has long been underserved.” Heart failure (HF) is a rapidly growing public health issue affecting over 60 million people worldwide and at least 15 million people in Europe alone. Approximately half of these patients suffer from HF with a LVEF of ≥40%, which is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. According to a study, the estimated costs related to heart failure in the EU in one year is about 29 billion Euros. The bulk of the costs is driven by repeat hospitalizations. By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. Finerenone has also been submitted for marketing authorization in this common form of heart failure in the U.S. and in China, and these applications are currently under review. Further regulatory applications to health authorities in other countries worldwide will follow. Submissions are based on positive data from the FINEARTS-HF study, which is part of MOONRAKER, one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings. About FINEARTS-HF FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities. With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings. About Kerendia ™ / Firialta ™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors. Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is currently not approved for the treatment of heart failure. The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE. About Heart Failure Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing. Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years. When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories: While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%. About Bayer’s Commitment in Cardiovascular and Kidney Diseases Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma SOURCE: Bayer

Clinical ResultDrug ApprovalPhase 3Phase 2AHA

22 Jan 2025

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. 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Phase 3Drug ApprovalLicense out/in

100 Deals associated with Finerenone

External Link

KEGG	Wiki	ATC	Drug Bank
D10633	Finerenone	-	DB16165

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Canada	Bayer, Inc.	14 Oct 2022
Chronic Kidney Diseases	South Korea	Bayer AG	10 May 2022
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Bayer HealthCare Pharmaceuticals, Inc.	09 Jul 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	NDA/BLA	United States	Bayer AG	10 Jan 2025
Diabetes Mellitus, Type 1	Phase 3	United States	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	China	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	Canada	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	Denmark	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	Germany	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	Italy	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	South Korea	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	Spain	Bayer AG	26 Feb 2024
Diabetes Mellitus, Type 1	Phase 3	United Kingdom	Bayer AG	26 Feb 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04435626 (FINEARTS-HF, Pubmed \| Circulation)	Phase 3	Heart failure with normal ejection fraction	6,001	Finerenone	ogvqbtcpyi(kxxaanxaae) = xpmfmrygjx divgramwod (bkusjpferd, 46 - 58)	Positive	07 Jan 2025
NCT04435626 (FINEARTS-HF, Pubmed \| JAMA Cardiol)	Phase 3	Heart failure with normal ejection fraction	6,001	Finerenone	zqtkrusgxk(ebtvetalux) = tnswluucmc wdltlrpuaj (cvzrawawge )	Positive	01 Jan 2025
NCT04435626 (FINEARTS-HF, Pubmed \| J Am Coll Cardiol)	Phase 3	Stroke \| Heart Failure eGFR \| UACR	-	Finerenone	zyibchpkuv(hxxpiurmtz) = jzcohixhsr dfpoiphzks (qtdmkqtjog )	Negative	01 Jan 2025
				Placebo	-
NCT04435626 (FINEARTS-HF, Pubmed \| JAMA Cardiol)	Phase 3	Heart failure with normal ejection fraction	6,001	Finerenone 20 mg	ksepmzbkdn(etkzktjqbm) = The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex ftempybybh (lpftxbmiov )	Positive	17 Nov 2024
				Finerenone 40 mg
NCT05348733 (FINE-REAL, Pubmed) Manual	Phase 4	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	504	Finerenone	hlawgonzaf(aagoycqqqf) = fzjleqtlde tffbrdehdv (phrsotfwjz ) View more	Positive	28 Sep 2024
NCT04435626 (FINEARTS-HF, Pubmed \| JAMA Cardiol) Manual	Phase 3	Heart Failure	6,001	Finerenone 20 mg	ueawjaxfmn(hkatyzvvir) = yefrnljxck awuexmcvjy (brkanuszye, 11.9 - 15.2) View more	Positive	27 Sep 2024
				Placebo	ueawjaxfmn(hkatyzvvir) = ploezpewri awuexmcvjy (brkanuszye, 6.8 - 11.3) View more
FINE-HEART (Company_Website) Manual	Not Applicable	Heart Failure \| Chronic Kidney Diseases	-	Finerenone	iffunggszs(gaksheopuh) = niwdxaevgb ddfkejfnyt (izmvkqcyyo ) View more	Positive	01 Sep 2024
				Placebo	iffunggszs(gaksheopuh) = ivocpntddu ddfkejfnyt (izmvkqcyyo ) View more
NCT04435626 (FINEARTS-HF, BusinessWire) Manual	Phase 3	Heart Failure	-	finerenone (LVEF ≥40%)	fujodxtqjk(qmtmcidxpw): RR = 0.84 (95% CI, 0.74 - 0.95), P-Value = 0.007 Met View more	Positive	01 Sep 2024
				Placebo (LVEF ≥40%)
NCT04435626 (FINEARTS-HF, Pubmed \| N Engl J Med)	Phase 3	Heart failure with normal ejection fraction	-	Finerenone 20 mg	qpntsxtxob(qdfnhchyxj) = increased risk metqhmmwpu (ibhsxrwwjp ) View more	Positive	01 Sep 2024
				Finerenone 40 mg
NCT04435626 (FINEARTS-HF, NEWS) Manual	Phase 3	Heart Failure	6,016	Kerendia	dslbiylzbv(bypzztxagp) = Top-line results showed that compared to placebo, Kerendia was associated with a significant and clinically meaningful reduction in the trial’s main goal. afxhjfkojc (hhsqpvkkve ) Met View more	Positive	05 Aug 2024
				Placebo

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