Heart Failure - Pipeline Insight, 2025

This “Heart Failure - Pipeline Insight, 2025” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Heart Failure pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

Heart Failure: Understanding

Heart Failure: Overview

Heart failure (HF) is a syndrome caused by structural and functional defects in myocardium resulting in impairment of ventricular filling or the ejection of blood. The most common cause for HF is reduced left ventricular myocardial function. Major pathogenic mechanisms leading to HF are increased hemodynamic overload, ischemia-related dysfunction, ventricular remodeling, excessive neuro-humoral stimulation, abnormal myocyte calcium cycling, excessive or inadequate proliferation of the extracellular matrix, accelerated apoptosis and genetic mutations. The common symptoms of congestive heart failure include fatigue, dyspnea, swollen ankles, and exercise intolerance, or symptoms that relate to the underlying cause. Patients with heart failure present with a variety of symptoms, most of which are non-specific. The accuracy of diagnosis by presenting clinical features alone, however, is often inadequate, particularly in women and elderly or obese patients. Mortality risk increases with each subsequent HF hospitalization. The presence of repeated hospitalizations, unplanned acute visits for HF decompensating, or complicated can suggest advanced HF.

The most important consideration when categorizing heart failure is whether left ventricular ejection fraction (LVEF) is preserved or reduced (less than 50 percent). A reduced LVEF in systolic heart failure is a powerful predictor of mortality. As many as 40 to 50 percent of patients with heart failure have diastolic heart failure with preserved left ventricular function. Patients with diastolic heart failure are more likely to be women, to be older, and to have hypertension, atrial fibrillation, and left ventricular hypertrophy/ Compared with systolic heart failure, which has well-validated therapies, diastolic heart failure lacks evidence-based treatment recommendations. There is no difference in survival between diastolic and systolic heart failure that cannot be attributed to ejection fraction.

The evaluation for HF is performed using various parameters like: physical examination to determine the presence of clinical symptoms and signs, blood tests, including complete blood count, urinalysis, complete metabolic profile for levels of serum electrolytes (including calcium and magnesium), blood urea nitrogen, serum creatinine, glucose, fasting lipid profile, liver function tests and thyroid-stimulating hormone. Other HF-specific laboratory tests include brain natriuretic peptide (BNP) with 70% sensitivity and 99% specificity and N-terminal proBNP (NT-proBNP) with 99% sensitivity and 85% specificity.

Considerable advances have been made in the drug treatment of heart failure over the past few decades. Spironolactone, angiotensin-converting enzyme inhibitors (ACEIs), and β-blockers are the only agents that have been shown to reduce heart failure mortality, and all are now widely used in the community. There are a number of agents in the early stage of development, which may have a potential role in the management of CHF.

"Heart Failure - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Heart Failure pipeline landscape is provided which includes the disease overview and Heart Failure treatment guidelines. The assessment part of the report embraces, in depth Heart Failure commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Heart Failure collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Heart Failure R&D. The therapies under development are focused on novel approaches to treat/improve Heart Failure.

Heart Failure Emerging Drugs Chapters

This segment of the Heart Failure report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Heart Failure Emerging Drugs

Rexlemestrocel-L: Mesoblast

Revascor consists of 150 million mesenchymal precursor cells (MPCs) administered by direct injection into the heart muscle in patients suffering from CHF and progressive loss of heart function. MPCs release a range of factors when triggered by specific receptor-ligand interactions within damaged tissue. Based on preclinical data, it is believed that these factors induce functional cardiac recovery by simultaneous activation of multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in cardiac scarring and fibrosis, and regeneration of heart muscle through activation of tissue precursors. Enrollment of 566 patients has been completed in a placebo-controlled Phase III trial to evaluate a single dose of Revascor in Class II/III CHF patients across multiple sites in North America. Patients with advanced heart failure constitute the majority of the patients enrolled in this clinical trial program. Currently, the drug is in Phase III stage of its development for the treatment of heart failure.

• HU 6: Rivus Pharmaceuticals

HU6 is a controlled metabolic accelerator (CMA) that provides a novel, measured approach to activating proton leak and mitochondrial uncoupling, a natural process in the body that regulates and dissipates energy. By ferrying protons out of the mitochondrial intermembrane space, CMAs cue the increased oxidation of sugars and fats, while maintaining the same baseline production of adenosine triphosphate (ATP). Activating this process results in the reduction of accumulated fat throughout the body. Currently, the drug is in Phase II stage of its development for the treatment of heart failure.

HS-001: Heartseed Inc

HS-001, is allogeneic iPSC-derived, highly purified ventricular cardio myocyte spheroids. By forming micro-tissue-like spheroids, retention rate and viability of cell transplant are improved. The spheroids are transplanted using a special administration needle (SEEDPLANTER®) and guide adapter developed for the administration of the spheroids into the myocardial layer of the heart. The expected mechanism of action is that the transplanted cardio myocytes electrically couple with the patient's myocardium to improve cardiac output by remuscularisation, and secretion of angiogenic factors to form new blood vessels around the transplant site (neovascularization). In June 2021, Heartseed and Novo Nordisk entered into global collaboration and license agreement for stem cell-based therapy for heart failure. Currently, the drug is in Phase I/II stage of its development for the treatment of heart failure.

• Ribonucleotide reductase based gene therapy: StemCardia

Ribonucleotide reductase based gene therapy is a novel investigational product candidate being developed by StemCardia. The drug candidate is based on Gene transference and Ribonucleotide reductase modulators mechanism of action. Currently, the drug is in preclinical stage of its development for the treatment of heart failure.

Heart Failure: Therapeutic Assessment

This segment of the report provides insights about the different Heart Failure drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Heart Failure

• There are approx. 70+ key companies which are developing the therapies for Heart Failure. The companies which have their Heart Failure drug candidates in the most advanced stage, i.e. phase III include, Mesoblast.

Phases

The report covers around 75+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Heart Failure pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Heart Failure: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Heart Failure therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Heart Failure drugs.

Heart Failure Report Insights

• Heart Failure Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Heart Failure Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Heart Failure drugs?
• How many Heart Failure drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Heart Failure?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Heart Failure therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Heart Failure and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Mesoblast
• Rivus Pharmaceuticals
• Heartseed Inc
• StemCardia
• Eli Lilly and Company
• BioCardia
• Bristol Myers Squibb
• Sardocor Corp.
• AstraZeneca
• Tenaya Therapeutics
• Salubris Bio therapeutics
• Moderna Therapeutics
• Cytokinetics
• Eli Lilly and Company
• Applied Therapeutics
• Help Therapeutics
• Stealth BioTherapeutics
• Actelion Pharmaceuticals
• Bayer HealthCare Pharmaceuticals/Merck & Co
• Servier
• Lexicon Pharmaceuticals
• Windtree Therapeutics

Key Products

• Rexlemestrocel-L
• HU 6
• HS-001
• Ribonucleotide reductase based gene therapy
• Tirzepatide
• CardiALLO cell therapy
• Mavacamten
• SRD-001
• AZD9977
• TN 301
• JK07
• mRNA 0184
• Omecamtiv mecarbil
• Neuregulin 4 agonist
• Caficrestat
• HiCM 188
• Elamipretide
• Macitentan
• Vericiguat
• Ivabradine
• Sotagliflozin
• Research programme: sarcoplasmic reticulum calcium transporting ATPase stimulants

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