Chronic Heart Failure Clinical Trials 2025: 25+ Pipeline Therapies, SGLT2 Inhibitors, Myosin Modulators, and Next-Gen Mechanisms Drive Progress

DelveInsight's "Chronic Heart Failure - Clinical Trials, 2025" highlights 25+ therapies in development for CHF, a progressive condition marked by high morbidity and mortality. Beyond cornerstone treatments such as sacubitril/valsartan and SGLT2 inhibitors, companies like Cytokinetics, Bayer, AstraZeneca, and Eli Lilly are advancing novel agents targeting fibrosis, energetics, and neurohormonal pathways.

The pipeline spans soluble guanylate cyclase stimulators, myosin modulators, metabolic agents, and anti-fibrotic therapies, with regenerative and gene-based approaches also under investigation. Trials such as COMET-HF (omecamtiv mecarbil) and next-gen phenotype-specific programs in HFrEF and HFpEF are actively shaping the clinical landscape.

With multiple Phase II and Phase III readouts expected through 2025, CHF development is shifting toward combination strategies layered on top of SGLT2 inhibitors and ARNIs, aiming to deliver meaningful reductions in hospitalizations and mortality while addressing persistent unmet needs in advanced heart failure.

Interested in learning more about the current treatment landscape and the key drivers shaping the chronic heart failure pipeline? Click here: https://www.delveinsight.com/report-store/chronic-heart-failure-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Chronic Heart Failure Pipeline Report
• DelveInsight's chronic heart failure pipeline analysis depicts a robust space with 25+ active players working to develop 25+ pipeline drugs for chronic heart failure treatment.
• The leading chronic heart failure companies include Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, Novartis, Boehringer Ingelheim, Bayer, BioCardia, Novo Nordisk, and others are evaluating their lead assets to improve the chronic heart failure treatment landscape.
• Key chronic heart failure pipeline therapies in various stages of development include Neucardin, Omecamtiv Mecarbil, Rexlemestrocel-L (Revascor), KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others.
• 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 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, Perfuze, a leading medical device company dedicated to advancing stroke treatment, announced that it has received FDA 510(k) clearance for its ZiplineTM Access Catheters. This regulatory milestone strengthens Perfuze's growing portfolio of innovative neurovascular devices, empowering physicians to treat acute Chronic Heart Failures with greater speed, ease, and precision.
• 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, 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.

Request a sample and discover the recent breakthroughs happening in the chronic heart failure pipeline landscape @ https://www.delveinsight.com/report-store/chronic-heart-failure-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Heart Failure Overview
Chronic heart failure (CHF) is a long-term condition where the heart cannot pump blood efficiently to meet the body's needs. It may result from various underlying causes such as coronary artery disease, hypertension, cardiomyopathy, or previous heart attacks. Symptoms typically include fatigue, shortness of breath, fluid retention, and reduced exercise tolerance.
CHF is classified into different types based on ejection fraction (HFrEF, HFpEF) and severity (NYHA classification). Management involves lifestyle changes, medications (e.g., ACE inhibitors, beta-blockers, diuretics), device therapy, and in severe cases, surgical interventions like heart transplants.
Despite treatment advances, CHF remains a progressive condition with high morbidity and mortality, requiring ongoing monitoring and individualized care.

Find out more about chronic heart failure medication @ https://www.delveinsight.com/report-store/chronic-heart-failure-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Heart Failure Treatment Analysis: Drug Profile
Neucardin - Zensun (Shanghai) Sci & Tech
Neucardin (recombinant human neuregulin-1) is a genetically engineered biologic developed by Zensun for treating mild to moderate chronic heart failure (CHF). It targets cardiac muscle cells to repair structural damage, enhance contraction and relaxation, improve heart function, and reverse pathological ventricular remodeling. Clinical evidence suggests it helps reduce mortality and hospital readmissions while improving quality of life. In August 2019, Neucardin received Fast Track designation from the U.S. FDA and priority review for conditional approval in China from the NMPA.

Omecamtiv Mecarbil - Cytokinetics
Omecamtiv mecarbil is a first-in-class small molecule that selectively activates cardiac myosin, developed to treat heart failure with reduced ejection fraction (HFrEF). It works by increasing the number of actin-myosin cross-bridges during systole, thereby improving cardiac contractility without raising intracellular calcium levels or oxygen consumption. This targeted mechanism aims to enhance cardiac performance safely and efficiently.

Learn more about the novel and emerging chronic heart failure pipeline therapies @ https://www.delveinsight.com/report-store/chronic-heart-failure-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Chronic 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
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Chronic Heart Failure Pipeline Report
• Coverage: Global
• Key Chronic Heart Failure Companies: Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, Novartis, Boehringer Ingelheim, Bayer, BioCardia, Novo Nordisk, and others.
• Key Chronic Heart Failure Pipeline Therapies: Neucardin, Omecamtiv Mecarbil, Rexlemestrocel-L (Revascor), KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others.

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

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

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

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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.