Thursday, August 21, 2025

Heart Failure Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

Heart Failure Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

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

Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Heart Failure Treatment Landscape @ Heart Failure Pipeline Outlook

Key Takeaways from the Heart Failure Pipeline Report

  • On 15 August 2025, Bristol-Myers Squibb announced a study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
  • On 14 August 2025, Pfizer conducted a study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.
  • On 12 August 2025, Novo Nordisk A/S organized a study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
  • DelveInsight's Heart Failure pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Heart Failure treatment.
  • The Heart Failure Companies such as 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.
  • Promising Heart Failure Pipeline Therapies such as Pirfenidone, KW-3902IV, Relaxin, Tolvaptan, Furosemide, Torsemide, Bumetanide, GSK716155, Dapagliflozin and others.

Stay informed about the cutting-edge advancements in Heart Failure treatments. Download for updates and be a part of the revolution in Cardiovascular Diseases Care @ Heart Failure Clinical Trials Assessment

Heart Failure Emerging Drugs Profile

  • 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.

The Heart Failure Pipeline Report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Heart Failure with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Heart Failure Treatment.
  • Heart Failure Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Heart Failure Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Heart Failure market.

Learn more about Heart Failure Drugs opportunities in our groundbreaking Heart Failure research and development projects @ Heart Failure Unmet Needs

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.

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

Heart Failure Products have been categorized under various Molecule types such as

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

Stay informed about how we're transforming the future of Cardiovascular Diseases @ Heart Failure Market Drivers and Barriers, and Future Perspectives

Scope of the Heart Failure Pipeline Report

  • Coverage- Global
  • 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.
  • Heart Failure Pipeline Therapies- Pirfenidone, KW-3902IV, Relaxin, Tolvaptan, Furosemide, Torsemide, Bumetanide, GSK716155, Dapagliflozin and others.
  • Heart Failure Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Heart Failure Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Heart Failure Pipeline on our website @ Heart Failure Emerging Drugs and Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Heart Failure: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Heart Failure – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Rexlemestrocel-L: Mesoblast
  9. Mid Stage Products (Phase II)
  10. HU 6: Rivus Pharmaceuticals
  11. Early Stage Products (Phase I/II)
  12. HS-001: Heartseed Inc
  13. Preclinical and Discovery Stage Products
  14. Ribonucleotide reductase based gene therapy: StemCardia
  15. Inactive Products
  16. Heart Failure Key Companies
  17. Heart Failure Key Products
  18. Heart Failure - Unmet Needs
  19. Heart Failure - Market Drivers and Barriers
  20. Heart Failure - Future Perspectives and Conclusion
  21. Heart Failure Analyst Views
  22. Heart Failure Key Companies
  23. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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