Heart Failure Clinical Trials Analysis 2025: SGLT2 Inhibitors, Novel Inotropes, and Anti-Inflammatory Therapies Aim to Improve Function and Survival | DelveInsight

DelveInsight's "Heart Failure - Clinical Trials Analysis, 2025" outlines a dynamic development landscape targeting the multifactorial pathophysiology of heart failure (HF), including myocardial dysfunction, fluid overload, and systemic inflammation. Trials increasingly assess both hard clinical endpoints (mortality, hospitalization) and patient-centered measures (exercise capacity, quality of life, functional status) to capture meaningful benefit across HF subtypes - HFrEF, HFpEF, and acute decompensated HF.

Late-stage and registration-enabling programs include SGLT2 inhibitors for cardiovascular and renal protection, novel inotropes and myosin modulators (e.g., omecamtiv mecarbil) to enhance contractility, and anti-inflammatory/metabolic agents aiming to reduce myocardial stress and improve remodeling. Combination strategies pairing pharmacologic agents with device-based interventions (e.g., cardiac resynchronization, neuromodulation) are also under investigation to optimize outcomes.

The clinical pipeline spans Phase II/III industry- and academic-led studies across chronic and acute HF populations. Key trial endpoints include 6-minute walk distance, NT-proBNP levels, echocardiographic parameters, hospitalization rates, and mortality, alongside patient-reported symptom and fatigue scales. Emerging trials increasingly incorporate biomarker-guided enrollment and precision endpoints to enrich for patients most likely to benefit.

Ongoing pivotal readouts over the next 12-24 months - from SGLT2 inhibitor expansions, myosin modulators, and anti-inflammatory therapies - will be critical in defining next-generation HF management strategies, potentially shifting care from symptom control toward improved survival, reduced hospitalizations, and enhanced functional outcomes.

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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 September 2025, Aptar Pharma announced that its Unidose Liquid System has been selected as the delivery platform for EnbumystTM (Bumetanide Nasal Spray) 0.5mg, recently approved by the U.S. FDA. Developed by Corstasis Therapeutics, EnbumystTM is the first intranasal loop diuretic approved for the treatment of edema associated with congestive heart failure, liver and kidney diseases, including nephrotic syndrome, in adults.
• In September 2025, Corstasis Therapeutics Inc. announced that the U.S. FDA has approved ENBUMYSTTM (bumetanide nasal spray) for the treatment of edema associated with congestive heart failure (CHF), as well as hepatic and renal diseases, including nephrotic syndrome in adults. ENBUMYST offers an enhanced outpatient therapeutic option for patients with cardiovascular and renal conditions.
• In August 2025, the FDA granted a second 510(k) clearance for Respiree's RS001 cardio-respiratory wearable, expanding its use to home-based care for patients with cardio-pulmonary diseases such as congestive heart failure and COPD.
• In July 2025, Tempus AI received FDA 510(k) clearance for its ECG-Low EF software, an AI tool that detects patients with low left ventricular ejection fraction (LVEF), a marker of heart failure risk. This is Tempus' second FDA-cleared AI device for cardiovascular conditions.
• In July 2025, the FDA approved Bayer's KERENDIA® (finerenone) for the treatment of heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, which includes HF with mildly reduced and preserved ejection fraction (HFmrEF and HFpEF). This approval follows Priority Review and is based on KERENDIA's ability to reduce cardiovascular death and heart failure-related hospitalizations significantly.
• In July 2025, Rocket Pharmaceuticals received FDA clearance for its Investigational New Drug (IND) application for RP-A701, a gene therapy targeting BAG3-associated Dilated Cardiomyopathy (BAG3-DCM)-a rare and severe form of heart failure marked by progressive heart enlargement and reduced pumping ability.
• In June 2025, Gradient Denervation Technologies was accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) to accelerate development and access of its novel pulmonary hypertension and heart failure treatment, following a recent breakthrough device designation.
• In June 2025, Mesoblast provided an update on ongoing engagement with the FDA regarding the accelerated approval pathway for Revascor® (rexlemestrocel-L) in patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, as well as a label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
• In May 2025, BiVACOR announced that its titanium Total Artificial Heart (TAH) received Breakthrough Device Designation from the FDA, recognizing its potential to address critical unmet needs in heart failure treatment.
• In April 2025, Mesoblast (ASX:MSB; Nasdaq:MESO) announced plans to meet with the U.S. FDA to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in treating ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.
• 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.

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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. Primary 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); a reduced LVEF is a strong predictor of mortality, while diastolic HF with preserved LVEF often affects older women with conditions such as 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 the induction of vascular network formation, reduction of inflammation and fibrosis, and regeneration of heart muscle through the activation of tissue precursors. 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 the accumulation of 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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.