Heart Failure Pipeline constitutes 70+ key companies continuously working towards developing 75+ Heart Failure treatment therapies, analyzes DelveInsight.
Heart Failure Overview:
Heart failure (HF) is a condition resulting from structural or functional heart abnormalities that impair the heart’s ability to fill with or pump blood effectively, most commonly due to reduced left ventricular function. Contributing factors include ischemia, increased hemodynamic stress, neuro-hormonal overactivation, ventricular remodeling, abnormal calcium signaling, extracellular matrix changes, cell death, and genetic predisposition. Symptoms often include fatigue, breathlessness, swelling in the ankles, and exercise intolerance, though diagnosis based on symptoms alone can be difficult—especially in women, the elderly, and those with obesity. Each hospitalization for HF increases the risk of death, signaling disease progression.
HF is categorized by left ventricular ejection fraction (LVEF): reduced LVEF (<50%), often seen in systolic HF, is linked with higher mortality. About 40–50% of HF patients have preserved LVEF, characteristic of diastolic HF, which is more common in older women with comorbidities like hypertension and atrial fibrillation. While systolic HF has well-defined treatments, diastolic HF lacks proven therapies, though survival rates are comparable between the two types.
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“Heart Failure Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Heart Failure Therapeutics Market.
Key Takeaways from the Heart Failure Pipeline Report
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DelveInsight’s Heart Failure pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Heart Failure treatment.
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In December 2025, Cytokinetics, Incorporated (Nasdaq: CYTK) announced the start of patient enrollment for COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a Phase 3 confirmatory trial assessing omecamtiv mecarbil in individuals with symptomatic heart failure (HF) and significantly reduced ejection fraction. Omecamtiv mecarbil is a novel investigational cardiac myosin activator being developed as a potential treatment for this condition. The trial is being conducted in partnership with the Duke Clinical Research Institute (DCRI), a prestigious academic research organization.
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In October 2025, Viatris signed an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all regions outside the US and EU.
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In September 2025, Bayer revealed the late-breaking Phase III FINE-HEART trial data for KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2025.
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In August 2025, Eli Lilly and Company (NYSE: LLY) reported positive topline results from the SUMMIT Phase 3 trial, which evaluated tirzepatide injection (5 mg, 10 mg, and 15 mg) in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Tirzepatide demonstrated statistically significant improvements in both primary endpoints, including a reduced risk of heart failure events (composite endpoint) and improved heart failure symptoms and physical limitations, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), compared to placebo.
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In May 2025, Eli Lilly and Company announced an additional USD 5.3 billion investment to expand manufacturing at its new Indiana site, aimed at increasing API production for tirzepatide and other pipeline drugs.
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AstraZeneca is expecting the Phase III BalanceD-HF trial results for balcinrenone (AZD9977) combined with dapagliflozin for heart failure in 2025.
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Key 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, Eli Lilly and Company, Applied Therapeutics, Help Therapeutics, Stealth BioTherapeutics, Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Merck & Co, Servier, Lexicon Pharmaceuticals, Windtree Therapeutics, and others are evaluating new drugs for Heart Failure to improve the treatment landscape.
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Promising Heart Failure pipeline therapies in various stages of development include Rexlemestrocel-L, HU 6, HS-001, Ribonucleotide reductase based gene therapy, and others.
Heart Failure Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Heart Failure Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Heart Failure treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging 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.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Heart Failure market.
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Heart Failure Emerging Drugs
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Rexlemestrocel-L: Mesoblast
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HU 6: Rivus Pharmaceuticals
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HS-001: Heartseed Inc
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Ribonucleotide reductase based gene therapy: StemCardia
Heart Failure Companies
Over 70 leading companies are engaged in developing treatments for heart failure. Among them, Mesoblast stands out with drug candidates that have reached the most advanced stage of development—Phase III clinical trials.
DelveInsight’s report covers around 75+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
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
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Heart Failure Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Heart Failure Pipeline Therapeutic Assessment
• Heart Failure Assessment by Product Type
• Heart Failure By Stage
• Heart Failure Assessment by Route of Administration
• Heart Failure Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Heart Failure Current Treatment Patterns
4. Heart Failure – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Heart Failure Late-Stage Products (Phase-III)
7. Heart Failure Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Heart Failure Discontinued Products
13. Heart Failure Product Profiles
14. Heart Failure Key Companies
15. Heart Failure Key Products
16. Dormant and Discontinued Products
17. Heart Failure Unmet Needs
18. Heart Failure Future Perspectives
19. Heart Failure Analyst Review
20. Appendix
21. Report Methodology
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