Heart Failure - Pipeline Insight, 2024

This “Heart Failure - Pipeline Insight, 2024” report provides comprehensive insights about 75+ companies and 90+ pipeline drugs in Heart Failure pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Heart Failure: Understanding

Heart Failure: Overview

Heart failure (HF) is a syndrome caused by structural and functional defects in myocardium resulting in impairment of ventricular filling or the ejection of blood. The most common cause for HF is reduced left ventricular myocardial function. Major pathogenic mechanisms leading to HF are increased hemodynamic overload, ischemia-related dysfunction, ventricular remodeling, excessive neuro-humoral stimulation, abnormal myocyte calcium cycling, excessive or inadequate proliferation of the extracellular matrix, accelerated apoptosis and genetic mutations. Heart failure is a pathological condition in which the heart is unable to pump enough blood to the rest of the body, because it is either unable to fill with a sufficient volume of blood or unable to generate sufficient force to pump out enough blood. Dysfunction of the pericardium, myocardium, endocardium, heart valves or great vessels alone or in combination is also associated with HF.

Heart failure can severely decrease the functional capacity of a patient and increase mortality risk. It is imperative to diagnose and effectively treat the disease to prevent recurrent hospitalizations, improve quality of life, and enhance patient outcomes. The treatment of heart failure requires a multifaceted approach involving patient education, optimal medical regimen to improve cardiac contractility, and prevention/limitation of exacerbations. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance and fluid retention, which may lead to pulmonary and/or splanchnic congestion and/or peripheral edema. Heart failure, remains a stubborn problem and is now considered to be the greatest challenge in cardiovascular medicine and surgery.

“Heart Failure - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Heart Failure pipeline landscape is provided which includes the disease overview and Heart Failure treatment guidelines. The assessment part of the report embraces, in depth Heart Failure commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Heart Failure collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Heart Failure R&D. The therapies under development are focused on novel approaches to treat/improve Heart Failure.

Heart Failure Emerging Drugs Chapters

This segment of the Heart Failure report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Heart Failure Emerging Drugs

Tirzepatide: Eli Lilly and Company Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for chronic weight management and heart failure with preserved ejection fraction(HFpEF).

Finerenone (BAY94-8862): Bayer Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block the harmful effects of the overactivated mineralocorticoid receptor (MR) system. MR overactivation is a major driver of heart and kidney damage. Current steroidal MRAs on the market have proven to be effective in reducing cardiovascular mortality in patients suffering from heart failure with reduced ejection fraction (HFr EF). However, they are often underutilized due to the incidence of hyperkalemia, renal dysfunction, and anti-androgenic / progestogenicsideeffects.

The initiation of the Phase III FINEARTS-HF study (FINerenone trial to investigate Efficacy and s Afety superioR to placebo in paTientS with Heart Failure) builds upon the robust Phase II studies ARTS-HF and ARTS-DN which investigated the efficacy and safety of finerenone in patients with heart failure and chronic kidney disease, respectively. Data from the Phase II study program ARTS were presented at ESC Congress 2015 inLondon.

Cardi AMP Cell Therapy: Bio CardiaCardi AMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The CardiAMP Cell Therapy Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively screen for cell therapeutic potency in order to improve patient outcomes. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy, which the company believes improves the probability of success of the treatment: a pre-procedural diagnostic for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and more successful forenhancingcellretention.

Firibastat: Quantum Genomics Firibastat is the first drug candidate in a new class of therapeutic agents called BAPAIs (Brain Aminopeptidase an Inhibitors). Firibastat is a prodrug that releases EC33, a specific and selective inhibitor of Aminopeptidase A in the brain, thereby preventing the production of angiotensin III in the brain. After collecting excellent data on animal efficacy and human safety in the Phase IIa study, Quantum Genomics announced the design of its Phase IIb study in heart failure last June 2018 with Firibastat. Firibastat currently is in Phase II for the HeartFailure.

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.

Heart Failure: Therapeutic Assessment

This segment of the report provides insights about the different Heart Failure drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Heart Failure

There are approx. 75+ key companies which are developing the therapies for Heart Failure. The companies which have their Heart Failure drug candidates in the most advanced stage, i.e. Phase III include, Eli Lilly and Company

Phases

This report covers around 90+ products under different phases of clinical development like

• 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

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

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Heart Failure: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Heart Failure therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Heart Failure drugs.

Heart Failure Report Insights

• Heart Failure Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Heart Failure Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Heart Failure drugs?
• How many Heart Failure drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Heart Failure?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Heart Failure therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Heart Failure and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Zensun (Shanghai) Sci & Tech
• Windtree Therapeutics
• Tree FrogTherapeutics
• Torrent Pharmaceuticals
• Tenaya Therapeutics
• Tasly Pharmaceuticals
• Sulfagenix
• Stealth BioTherapeutics
• SQ Innovation
• Shanghai Hongyitang Biopharmaceutical Technology
• scPharmaceuticals
• Sardocor
• Sana Biotechnology
• Salubris Biotherapeutics
• Roche
• Rivus Pharmaceuticals
• Ribomic
• Renova Therapeutics
• Relaxera
• Regeneron Pharmaceuticals
• Recardio
• Quantum Genomics
• Procella Therapeutics
• Precigen
• Pfizer
• Paradigm biopharmaceuticals
• Palatin Technologies
• Orizuru Therapeutics
• Olatec Therapeutics
• Novo Nordisk
• Metcela
• Mesoblast Inc.
• Merck & Co
• Lexicon Pharmaceuticals
• Janssen Research & Development
• Ionis Pharmaceuticals
• InvivoSciences
• Intra-Cellular Therapies
• Innolife
• Imbria Pharmaceuticals
• Imara Inc
• Hyloris Pharmaceuticals
• Help Therapeutics
• Heartseed
• HAYA Therapeutics
• GlaxoSmithKline
• GB Sciences
• Fujifilm Corporation
• Evotec SE
• Eli Lilly and Company
• Edgewise Therapeutics
• DiNAQOR
• Cytokinetics
• CUORiPS
• Chong Kun Dang
• Cardurion Pharmaceuticals
• Cardior Pharmaceuticals
• Cardiol Therapeutics
• CardioCell
• Bristol-Myers Squibb
• Boryung Pharmaceutical
• Blue RockTherapeutics
• BioCardia
• BIAL
• Berlin Cures
• BenevolentAI
• Bayer
• Athersys
• AstraZeneca
• Asklepios Biopharmaceutical
• Antlia Biosciences
• AnaCardio
• AliveGen
• Actelion Pharmaceuticals

Key Products

• Recombinant Human Neuregulin-1ß (rhNRG-1)
• Istaroxime
• SERCA2a activators
• hi PSC-derived cardiaccells
• TRC 041266
• TN-301
• AAV-Based Research Project
• DWORF
• Qishenyiqi Dripping Pills
• SG1002
• Elamipretide
• SQIN-01
• TSG-01
• Furoscix
• SRD-001
• SC 187
• JK-07
• Pirfenidone
• HU6
• RBM-003
• RT 100
• Relaxin-2
• REGN5381
• REC 02
• Firibastat
• Heart Failure Research Project
• PROC-001
• INXN-4001
• Sildenafil citrate
• APD-418
• Prazosin hydrochloride
• Pentosan Polysulfate Sodium (PPS)
• PL 3994
• IPSC-derived cardiomyocyte
• Dapansutrile
• Semaglutide
• MTC001
• Rexlemestrocel-L (Revascor)
• Ertugliflozin
• Sotagliflozin
• Rivaroxaban
• IONIS-AGT-LRx
• IVS201
• Lenrispodun
• INL 1
• IMB-101
• IMR-687
• Milrinone
• Metolazone IV
• HiCM-188
• HS-001
• Antisense oligonucleotide based therapy
• GSK3884464

Research programme: heart failure therapeutics- i PSC-derived cardiac progenitorcells

• IPSC-Based Tissue Therapy
• Tirzepatide
• LY3461767
• EDG 002
• DINA-007/A
• DINA-007/B
• Omecamtiv mecarbil
• CK-136
• IPSC-derived cell
• CKD-349
• CRD 733

Research programme: cardiovascular therapies- CRD-102

• CDR132L
• CardiolRx
• Allogeneic Mesenchymal Bone Marrow Cells
• Mavacamten
• BMS-986231
• FA relaxin
• ROMK inhibitor
• BR1016C
• BR1016A

Research programme: induced pluripotent stem cell therapeutics- Cardi AMP celltherapy

• Cardi ALLO CellTherapy
• Zamicastat
• BC-007

Research programme: therapeutics- Finerenone (BAY 94-8862)

• Pecavaptan
• Multi Stem celltherapy
• AZD4831
• AZD 9977
• AZD-8601

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