Heart Failure Pipeline: 70+ Pioneering Companies Advancing the Next Wave of Innovative Therapies and Drug Development | DelveInsight

The heart failure therapeutics and device market is experiencing a significant transformation, driven by key innovators such as Moderna Therapeutics, Cytokinetics, Applied Therapeutics, Help Therapeutics, and Stealth BioTherapeutics. With the development of advanced therapies, including SGLT2 inhibitors, ARNIs, and heart failure devices, these companies are reshaping treatment paradigms. The pipeline is primarily focused on improving outcomes for patients with chronic heart failure, addressing unmet needs, and enhancing long-term management strategies. New innovations in pharmacological and device-based therapies are offering new hope for more effective heart failure treatment and improved patient quality of life.

DelveInsight's "Heart Failure Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Heart Failure market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging heart failure drugs, the heart failure pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Heart Failure Pipeline Report
• DelveInsight's heart failure pipeline analysis depicts a strong space with 70+ active players working to develop 75+ pipeline drugs for Heart Failure treatment.
• The leading heart failure companies include 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, Applied Therapeutics, Help Therapeutics, Stealth BioTherapeutics, Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals/Merck & Co, Servier, Lexicon Pharmaceuticals, Windtree Therapeutics, and others are evaluating their lead assets to improve the heart failure treatment landscape.
• Key heart failure pipeline therapies in various stages of development include 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, and others.
• In March 2025, Alnylam Pharmaceuticals announced FDA approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA® (vutrisiran), for treating the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, hospitalizations, and urgent heart failure visits.
• In March 2025, Secretome Therapeutics announced the dosing of the first patient in its Phase 1 clinical trial evaluating STM-01, derived from neonatal cardiac progenitor cells (nCPC), as a treatment for heart failure with preserved ejection fraction (HFpEF).
• In January 2025, the FDA approved the abbreviated new drug application (ANDA) for Lupin's Sacubitril and Valsartan tablets, the generic equivalent of Novartis' Entresto, used to reduce cardiovascular risks in adults with chronic heart failure and decreased ejection fraction.
• In January 2025, SeaStar Medical Holding Corporation announced that the FDA approved its investigational device exemption (IDE) application for the Selective Cytopheretic Device (SCD-ADULT). The device will be evaluated for its safety and efficacy in reducing inflammation in adult patients with acute heart failure and worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting LVAD implantation.
• In January 2025, Alleviant Medical, Inc. announced that the FDA has granted investigational device exemption (IDE) approval to begin a pivotal trial for patients with heart failure with reduced ejection fraction (HFrEF), one of the most common forms of heart failure.
• In January 2025, FIRE1 announced it received Breakthrough Device Designation from the FDA and was accepted into the FDA's Total Product Lifecycle Advisory Program (TAP). FIRE1's Norm heart failure management system empowers patients with physician-directed self-management, reducing healthcare staff burden and helping patients stay healthier at home.
• In January 2025, EBR Systems, Inc. announced that the FDA has scheduled a Pre-Approval Inspection for its WiSE CRT System, the world's only wireless cardiac pacing device, starting January 14, 2025. This inspection is vital for regulatory compliance and the system's commercial launch later in the year. The FDA's Breakthrough Device designation supports prioritized review, potentially strengthening EBR's market position and providing better treatments for heart failure patients.

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Heart Failure Overview
Heart failure (HF) is a syndrome caused by structural and functional defects in the myocardium, leading to impaired blood flow due to reduced left ventricular function. Major causes include increased hemodynamic overload, ischemia, ventricular remodeling, and abnormal calcium cycling. Symptoms such as fatigue, dyspnea, and exercise intolerance are common, but diagnosis based solely on clinical features can be inadequate, especially in women, the elderly, or obese patients.

HF is categorized based on left ventricular ejection fraction (LVEF); reduced LVEF is a strong mortality predictor, while diastolic HF with preserved LVEF often affects older women with conditions like hypertension and atrial fibrillation. Though systolic heart failure has validated therapies, diastolic heart failure lacks strong evidence-based treatments. Evaluation involves physical exams, blood tests, and biomarkers like BNP and NT-proBNP. Significant advancements in treatment, such as ACE inhibitors, β-blockers, and spironolactone, have reduced mortality, and emerging therapies may offer further benefits for managing chronic heart failure.

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Heart Failure Treatment Analysis: Drug Profile
Rexlemestrocel-L: Mesoblast
Revascor, consisting of 150 million mesenchymal precursor cells (MPCs), is administered via direct injection into the heart muscle for patients with chronic heart failure (CHF) and progressive heart dysfunction. MPCs release factors that activate multiple recovery pathways in damaged tissue, including inducing vascular network formation, reducing inflammation and fibrosis, and regenerating heart muscle through tissue precursor activation. A Phase III, placebo-controlled trial has enrolled 566 patients with Class II/III CHF across multiple North American sites to evaluate a single dose of Revascor. The drug is currently in Phase III for heart failure treatment.

HU 6: Rivus Pharmaceuticals
HU6 is a controlled metabolic accelerator (CMA) that activates proton leak and mitochondrial uncoupling, processes that regulate energy dissipation in the body. By promoting the oxidation of sugars and fats without altering ATP production, HU6 helps reduce accumulated fat. It is currently in Phase II for the treatment of heart failure.

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Heart Failure Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Heart Failure Pipeline Report
• Coverage: Global
• Key Heart Failure Companies: 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, Applied Therapeutics, Help Therapeutics, Stealth BioTherapeutics, Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals/Merck & Co, Servier, Lexicon Pharmaceuticals, Windtree Therapeutics, and others.
• Key Heart Failure Pipeline Therapies: 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, and others.

Dive deep into rich insights for drugs used for heart failure treatment; visit @ https://www.delveinsight.com/report-store/heart-failure-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Heart Failure Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Heart Failure Pipeline Therapeutics
6. Heart Failure Pipeline: Late-Stage Products (Phase III)
7. Heart Failure Pipeline: Mid-Stage Products (Phase II)
8. Heart Failure Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.