“Heart Failure Pipeline Insight, 2026“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Heart Failure Market.

The Heart Failure Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Heart Failure Pipeline Report:

• Companies across the globe are diligently working toward developing novel Heart Failure treatment therapies with a considerable amount of success over the years.

• Heart Failure companies working in the treatment market are Tenaya Therapeutics, Athersys, TransThera Biosciences, SalubrisBio, Ionis Pharmaceuticals, Arena Pharmaceuticals, Palatin Technologies, Bayer HealthCare, Eli Lilly and Company, and others, are developing therapies for the Heart Failure treatment

• Emerging Heart Failure therapies in the different phases of clinical trials are- TN-301, Invimestrocel, TT-00920, JK-07, IONIS AGT LRx, APD418, PL-3994, Finerenone, Tirzepatide, and others are expected to have a significant impact on the Heart Failure market in the coming years.

• In October 2026, Cardurion reported Phase II findings from its Cycle clinical program, highlighting the potential of tovinontrine, an investigational PDE9 inhibitor, in patients with heart failure with reduced ejection fraction (HFrEF). The treatment demonstrated sustained reductions in NT-proBNP levels over 12 weeks and exhibited a favorable safety and tolerability profile. Based on these results, the company intends to further advance the clinical development of tovinontrine.

• In October 2026, Noah Labs announced the enrollment of the first participants in its pivotal VOICE-HF clinical trial, which will assess an AI-driven voice monitoring technology designed to identify worsening heart failure through daily voice recordings. The investigational device has received FDA Breakthrough Device Designation, while the study aims to generate clinical evidence to support a potential future FDA De Novo submission.

• In September 2026, Novo Nordisk announced the discontinuation of two additional late-stage clinical trials evaluating ziltivekimab in patients with heart failure. The decision came after an independent data-monitoring committee concluded that the studies were unlikely to deliver clinically meaningful benefits, following disappointing cardiovascular outcome results reported in July 2026.

• In September 2026, The U.S. Food and Drug Administration (FDA) granted De Novo authorization to Powerful Medical’s Queen of Hearts, an artificial intelligence (AI)-powered model developed to identify acute coronary syndrome (ACS) using electrocardiogram (ECG) analysis. The technology is intended to facilitate early detection of suspected ACS cases, enabling timely cardiology consultations and prompt cardiac catheterization when needed. Although ACS is frequently linked to heart attacks, it also encompasses conditions such as unstable angina, which may signal an elevated risk of an impending heart attack.

• In August 2026, Tenax Therapeutics released topline findings from its Phase III LEVEL trial investigating oral levosimendan in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The study demonstrated improvements in exercise capacity among selected prespecified patient subgroups, along with encouraging biomarker and hemodynamic outcomes. The company is advancing the therapy’s clinical development through the ongoing Phase III LEVEL-2 trial.

• In August 2026, Results from the Phase IIb LUMINARA trial were presented at ESC Congress 2026, highlighting the potential of the investigational oral relaxin agonist to improve cardiac function in patients with HFrEF and lower systemic vascular resistance in those with HFpEF. These findings support further clinical evaluation to determine its long-term therapeutic benefits in heart failure.

• In July 2026, Novo Nordisk announced underwhelming cardiovascular outcome results for ziltivekimab, as the treatment did not demonstrate a reduction in major adverse cardiovascular events compared with placebo. Following these findings, the company discontinued two additional late-stage clinical trials investigating ziltivekimab in heart failure in September 2026.

• In June 2026, A Phase III clinical trial investigating the long-term safety of finerenone in pediatric and young adult patients with heart failure and left ventricular systolic dysfunction commenced in June 2026. The study is designed to provide further safety data on the use of finerenone in younger patients with heart failure.

• In November 2025, Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (“Cardiol” or the “Company”), a clinical-stage life sciences firm focused on developing anti-inflammatory and anti-fibrotic therapies for heart disease, announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for its patent application titled “Cannabidiol Compositions for Use in Treating Heart Conditions.” Once granted, this patent will provide broad intellectual property protection for the use of CardiolRx™ and CRD-38 in treating or preventing a wide array of cardiac conditions, including heart failure, myocarditis, acute pericarditis, inflammatory cardiomyopathy, cardiac toxicity from cancer therapies, and atherosclerosis, extending through October 2040.

• In May 2025, BioCardia announced the enrollment of the first participant in its randomized, double-blind, placebo-controlled Phase III CardiAMP HF II trial, evaluating its autologous cell therapy for ischemic heart failure. The enrollment occurred at BayCare Morton Plant Hospital in Clearwater, Florida, U.S. The 250-patient, multicenter study is designed to assess a single administration of CardiAMP therapy in patients with ischemic HF with reduced ejection fraction (HFrEF), who are on guideline-directed medical therapy and have elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) levels.

• In May 2025, Medera Inc., a clinical-stage biopharmaceutical company developing next-generation therapies for cardiovascular diseases, announced that data from its First-In-Human Phase 1/2a MUSIC-HFpEF trial of the adeno-associated virus-based gene therapy candidate SRD-002 for heart failure with preserved ejection fraction (HFpEF) will be presented at the upcoming Heart Failure 2025 Congress.

• In April 2025, Emory University School of Medicine in the U.S. began enrolling participants for BioCardia’s Phase III CardiAMP HF II trial, evaluating the CardiAMP Cell Therapy Product for the treatment of ischemic heart failure. The study is focused on patients with reduced ejection fraction and elevated cardiac stress markers.

• In April 2025, An independent Data Safety Monitoring Board (DSMB) has recommended that BioCardia continue its Phase I/II CardiALLO-HF trial as planned. This decision follows a review of 30-day safety data from participants in the trial’s low-dose 20 million cell cohort, which showed no treatment-related adverse cardiac events or immune responses to the implanted allogeneic cells. With DSMB approval, BioCardia plans to expand the study by enrolling 39 additional participants across the U.S. The trial is designed to evaluate the safety and efficacy of mesenchymal stromal/stem cells (MSCs) in treating heart failure.

Heart Failure Overview

Heart Failure (HF) is a chronic condition in which the heart cannot pump blood effectively or fill adequately to meet the body’s oxygen and blood supply requirements. It may develop due to coronary artery disease, high blood pressure, diabetes, or other cardiovascular conditions. Common symptoms include shortness of breath, fatigue, swelling in the legs and ankles, and reduced exercise tolerance. Heart failure management includes medications, lifestyle modifications, cardiac devices, and advanced interventions, depending on disease severity.

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Emerging Heart Failure Drugs Under Different Phases of Clinical Development Include:

• TN-301: Tenaya Therapeutics

• Invimestrocel: Athersys

• TT-00920: TransThera Biosciences

• JK-07: SalubrisBio

• IONIS AGT LRx: Ionis Pharmaceuticals

• APD418: Arena Pharmaceuticals

• PL-3994: Palatin Technologies

• Finerenone: Bayer HealthCare Pharmaceuticals

• Tirzepatide: Eli Lilly and Company

Heart Failure 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

• Intra-articular

• Intraocular

• Intrathecal

• Intravenous

• Ophthalmic

• Oral

• Parenteral

• Subcutaneous

• Topical

• Transdermal

Heart Failure Molecule Type

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

• Oligonucleotide

• Peptide

• Small molecule

Heart Failure Pipeline Therapeutics Assessment

• Heart Failure Assessment by Product Type

• Heart Failure By Stage and Product Type

• Heart Failure Assessment by Route of Administration

• Heart Failure By Stage and Route of Administration

• Heart Failure Assessment by Molecule Type

• Heart Failure by Stage and Molecule Type

DelveInsight’s Heart Failure 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)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Heart Failure product details are provided in the report. Download the Heart Failure pipeline report to learn more about the emerging Heart Failure therapies

Some of the key companies in the Heart Failure Therapeutics Market include:

Key companies developing therapies for Heart Failure are – Abbott Laboratories, Berlin Heart GmbH, Biotronik SE & Co. KG, Boston Scientific Corporation, Jarvik Heart Inc., Lepu Medical Technology (Beijing)Co.,Ltd., Magenta Medical Ltd, MEDICO S.R.L., Medtronic PLC, Oscor, Inc., OSYPKA MEDICAL, Shree Pacetronix Ltd, and others.

Heart Failure Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Heart Failure drugs and therapies

Heart Failure Pipeline Market Drivers

• Alongside these drug launches, a new therapeutic strategy is being explored, prevalence of chronic heart failure on the rise, strong collaboration between main stakeholders of therapeutic innovation: scientific community, industry and regulatory agencies are some of the important factors that are fueling the Heart Failure Market.

Heart Failure Pipeline Market Barriers

• However, true surrogate marker for mortality in heart failure (HF) remains elusive, high cost of approved therapies, transition of a clinical HFrEF project from one stage of development to the next is still associated with considerable development risk and other factors are creating obstacles in the Heart Failure Market growth.

Scope of Heart Failure Pipeline Drug Insight

• Coverage: Global

• Key Heart Failure Companies: Tenaya Therapeutics, Athersys, TransThera Biosciences, SalubrisBio, Ionis Pharmaceuticals, Arena Pharmaceuticals, Palatin Technologies, Bayer HealthCare, Eli Lilly and Company, and others

• Key Heart Failure Therapies: TN-301, Invimestrocel, TT-00920, JK-07, IONIS AGT LRx, APD418, PL-3994, Finerenone, Tirzepatide, and others

• Heart Failure Therapeutic Assessment: Heart Failure current marketed and Heart Failure emerging therapies

• Heart Failure Market Dynamics: Heart Failure market drivers and Heart Failure market barriers

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Table of Contents

1. Heart Failure Report Introduction

2. Heart Failure Executive Summary

3. Heart Failure Overview

4. Heart Failure- Analytical Perspective In-depth Commercial Assessment

5. Heart Failure Pipeline Therapeutics

6. Heart Failure Late Stage Products (Phase II/III)

7. Heart Failure Mid Stage Products (Phase II)

8. Heart Failure Early Stage Products (Phase I)

9. Heart Failure Preclinical Stage Products

10. Heart Failure Therapeutics Assessment

11. Heart Failure Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Heart Failure Key Companies

14. Heart Failure Key Products

15. Heart Failure Unmet Needs

16 . Heart Failure Market Drivers and Barriers

17. Heart Failure Future Perspectives and Conclusion

18. Heart Failure Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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