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Report Overview
Heart failure with reduced ejection fraction (HFrEF) is a chronic cardiac disorder where the left ventricle pumps less effectively (LVEF ≤40%), leading to fatigue, dyspnea, and fluid retention. It represents roughly half of all HF cases and contributes substantially to morbidity and healthcare burden. Globally, heart failure affects about 1-2 % of adults, with prevalence rising due to aging populations and comorbidities such as hypertension and diabetes. According to the heart failure (HF) with reduced ejection fraction (HFrEF) pipeline analysis by Expert Market Research, growing R&D investments and novel mechanisms are driving an expanding pipeline of therapies, including agents in Phase II/III stages targeting improved cardiac function and outcomes. This focus reflects unmet needs and is expected to accelerate market growth in the coming years as innovative treatments enter clinical use.
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Major companies involved in the heart failure (HF) with reduced ejection fraction (HFrEF) pipeline analysis include Merck, Salubris Biotherapeutics Inc., and others.
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Leading drugs currently in the pipeline include Vericiguat, JK07, YAP101, and others.
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The pipeline expansion is driven by the development of novel SGLT2 inhibitors, next-generation ARNi therapies, and gene-based treatments, targeting improved cardiac function and reduced hospitalization rates in HFrEF patients.
Report Coverage
The Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Analysis Report by Expert Market Research gives comprehensive insights into heart failure (HF) with reduced ejection fraction (HFrEF) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for heart failure (HF) with reduced ejection fraction (HFrEF). The heart failure (HF) with reduced ejection fraction (HFrEF) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The heart failure (HF) with reduced ejection fraction (HFrEF) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with heart failure (HF) with reduced ejection fraction (HFrEF) treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to heart failure (HF) with reduced ejection fraction (HFrEF).
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Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Outlook
Heart failure with reduced ejection fraction (HFrEF) is a chronic condition where the heart’s left ventricle cannot pump blood effectively, leading to reduced cardiac output. It often develops due to coronary artery disease, hypertension, or myocardial injury, causing weakened heart muscle and impaired contractility.
Heart failure with reduced ejection fraction (HFrEF) treatment includes guideline-directed therapies such as angiotensin-converting enzyme inhibitors, beta-blockers, mineralocorticoid receptor antagonists, sodium-glucose co-transporter 2 inhibitors, diuretics, which aims to manage symptoms and improve survival. In February 2022, Cytokinetics announced the FDA acceptance of a New Drug Application for omecamtiv mecarbil, a selective cardiac myosin activator, targeting HFrEF patients. The Phase 3 GALACTIC-HF trial showed reduced risk of cardiovascular death or heart failure events.
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Epidemiology
The global burden of heart failure with reduced ejection fraction (HFrEF) is rising steadily. According to Harikrishnan Sivadasanpillai et al., 2024, 56.1 million people worldwide had heart failure in 2019, with an age-standardised prevalence of 711.90 per 100,000 population. Prevalence is highest in North America (over 1,000/100,000) and Oceania, and lowest in South Asia (below 500/100,000). Ischemic heart disease and hypertension are the leading causes, with prevalence rates of 265.72 and 233.77 per 100,000, respectively. Years lived with disability reached 5.05 million globally. Between 1990 and 2019, prevalence increased most in Oman (29%), Cameroon (26%), and Saudi Arabia (21%).
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) – Pipeline Therapeutic Assessment
This section of the report covers the analysis of heart failure (HF) with reduced ejection fraction (HFrEF) drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
The heart failure (HF) with reduced ejection fraction (HFrEF) pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
- Peptides
- Oligonucleotides
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration:
- Oral
- Parenteral
- Others
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase I, II and IV cover a major share of the total heart failure (HF) with reduced ejection fraction (HFrEF) clinical trials. Each phase holds 33%, representing the most active development stages. The strong presence in phases I, II, and IV indicates ongoing innovation and potential near- to mid-term market growth, enhancing treatment options for HFrEF patients.
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under heart failure (HF) with reduced ejection fraction (HFrEF) pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and oligonucleotides. The heart failure (HF) with reduced ejection fraction (HFrEF) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for heart failure (HF) with reduced ejection fraction (HFrEF). Cardiac myosin activators are emerging as a novel drug class in the Heart Failure with Reduced Ejection Fraction drug pipeline to directly enhance myocardial contractility. For instance, omecamtiv mecarbil, a selective cardiac myosin activator developed by Cytokinetics, is currently being evaluated in the Phase 3 COMET-HF trial for patients with symptomatic HFrEF and severely reduced ejection fraction, aiming to improve clinical outcomes.
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Clinical Trials – Key Players
The EMR report for the heart failure (HF) with reduced ejection fraction (HFrEF) pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed heart failure (HF) with reduced ejection fraction (HFrEF) therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in heart failure (HF) with reduced ejection fraction (HFrEF) clinical trials:
- Merck
- Salubris Biotherapeutics Inc.
- YAP Therapeutics, Inc.
- AstraZeneca
- Novartis Pharmaceuticals
- Bayer
- Cellular Therapies, Inc.
- Abbott
- Braun Melsungen AG
- Teleflex Incorporated
- Abiomed
- Edwards Life Sciences
Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) – Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for heart failure (HF) with reduced ejection fraction (HFrEF). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of heart failure (HF) with reduced ejection fraction (HFrEF) drug candidates.
Drug: Vericiguat
VERQUVO® (vericiguat) is being developed by Merck in collaboration with Bayer as an oral, once-daily soluble guanylate cyclase (sGC) stimulator targeting patients with chronic heart failure with reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial is examining VERQUVO in ambulatory HFrEF patients without recent worsening heart failure events to assess its efficacy and safety alongside guideline-directed medical therapy. VERQUVO works by enhancing cGMP production, promoting smooth muscle relaxation, vasodilation, and improving cardiac function. Administered orally, it aims to reduce cardiovascular death and heart failure hospitalizations. The pooled analysis with VICTORIA supports its benefit across a broad HFrEF population.
Drug: JK07
JK07, sponsored by Salubris Biotherapeutics Inc, is currently undergoing a Phase 2, randomized, double-blind, placebo-controlled study (RENEU-HF) to evaluate its safety, tolerability, and efficacy in adults with chronic heart failure, including HFrEF. This recombinant antibody fusion protein combines a polypeptide fragment of human neuregulin-1 (NRG-1) with a fully human IgG1 monoclonal antibody targeting ErbB3. By selectively blocking ErbB3 and activating the ErbB4 pathway, JK07 is promoting cardiac regeneration while reducing side effects. Administered via intravenous infusion, the study is examining its therapeutic potential in patients with left ventricular ejection fractions ≤40% and 41–65%.
Combination Product: YAP101
YAP101, sponsored by YAP Therapeutics, Inc., is a pioneering gene therapy designed to treat adults with ischemic heart failure and reduced ejection fraction (HFrEF). This Phase I trial examines the safety, tolerability, and preliminary efficacy of YAP101, which works by delivering adeno-associated virus (AAV9) carrying short hairpin RNAs (shRNAs) targeting Salvador 1 (SAV1) to cardiomyocytes. By transiently suppressing the Hippo signaling pathway, YAP101 activates heart muscle regeneration, reduces fibrosis, and improves cardiac function. Administered via a one-time transendocardial injection using a minimally invasive cardiac catheter, the study monitors participants over 12 months for cardiac function, exercise tolerance, and quality of life improvements.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
Key Questions Answered in the Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Insight Report
- Which companies/institutions are leading the heart failure (HF) with reduced ejection fraction (HFrEF) drug development?
- Which company is leading the heart failure (HF) with reduced ejection fraction (HFrEF) pipeline development activities?
- What is the current heart failure (HF) with reduced ejection fraction (HFrEF) commercial assessment?
- What are the opportunities and challenges present in the heart failure (HF) with reduced ejection fraction (HFrEF) pipeline landscape?
- What is the efficacy and safety profile of heart failure (HF) with reduced ejection fraction (HFrEF) pipeline drugs?
- Which company is conducting major trials for heart failure (HF) with reduced ejection fraction (HFrEF) drugs?
- Which companies/institutions are involved in heart failure (HF) with reduced ejection fraction (HFrEF) collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in heart failure (HF) with reduced ejection fraction (HFrEF)?
Reasons To Buy This Report
The Heart Failure (HF) with Reduced Ejection Fraction (HFrEF) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for heart failure (HF) with reduced ejection fraction (HFrEF). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into heart failure (HF) with reduced ejection fraction (HFrEF) collaborations, regulatory environments, and potential growth opportunities.
Related Reports
Congestive Heart Failure (CHF) Epidemiology Forecast
Chronic Heart Failure Pipeline Analysis Report
Advanced Heart Failure Epidemiology Forecast
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Report Summary
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
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