Hypercholesterolemia Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "Hypercholesterolemia Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the hypercholesterolemia market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging hypercholesterolemia drugs, the hypercholesterolemia pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The hypercholesterolemia market is being reshaped by biologics, RNA-based therapies, and gene-editing tools developed by industry leaders such as Amgen, Novartis, Verve Therapeutics, Arrowhead Pharmaceuticals, and LIB Therapeutics. With innovations like PCSK9 inhibitors, ANGPTL3 silencers, and CRISPR-based precision therapies, companies are offering more durable lipid-lowering solutions beyond statins. These advancements are setting the stage for personalized cholesterol management, particularly in patients who are genetically predisposed or intolerant to statins.

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Key Takeaways from the Hypercholesterolemia Pipeline Report
• DelveInsight's hypercholesterolemia pipeline analysis depicts a robust space with 25+ active players working to develop 25+ pipeline drugs for hypercholesterolemia treatment.
• The leading hypercholesterolemia companies include Innovent, Akeso Biopharma, Ahn-Gook Pharmaceuticals Co., Ltd, Jiangsu Hengrui Medicine Co., Merck Sharp & Dohme LLC, Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Addpharma Inc., Verve Therapeutics, Inc., Novo Nordisk, NewAmsterdam Pharma, Vaxxinity, Nyrada, Sirnaomics, HighTide Biopharma, Luye Pharma, Shandong Boan Biotechnology, CiVi Biopharma, Precision biosciences, SalioGen Therapeutics, and others are evaluating their lead assets to improve the Hypercholesterolemia treatment landscape.
• Key hypercholesterolemia pipeline therapies in various stages of development include Tafolecimab, Ebronucimab, AGT 2, SHR-1209, MK-0616, ARO-ANG 3, Lerodalcibep, PBGENE-PCSK9 candidate, CiVi 008, AD-221, VERVE-101, STP 135G, NNC 03850434, Obicetrapib, NYX 330, and others.
• In March 2025, Esperion (NASDAQ: ESPR) announced FDA alignment to initiate Phase III trials of bempedoic acid, alone and in combination with ezetimibe, for pediatric patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH). Bempedoic acid has Orphan Drug Designation for HoFH.
• In February 2025, LIB Therapeutics announced FDA acceptance of the BLA for Lerodalcibep to reduce LDL-C in patients with atherosclerotic cardiovascular disease (ASCVD), or high-risk hypercholesterolemia, including HeFH and HoFH in individuals aged 10 and above.
• In January 2025, LIB Therapeutics published positive Phase III LIBerate-HoFH results for Lerodalcibep in The Lancet Diabetes & Endocrinology, demonstrating efficacy in a global HoFH hypercholesterolemia population.

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Hypercholesterolemia Overview
Hypercholesterolemia refers to high blood cholesterol levels, which can result from excess cholesterol production by the liver or from dietary sources such as meat, poultry, dairy, egg yolk, and fish. While cholesterol is essential for functions like cell membrane synthesis and hormone production, elevated levels can lead to coronary artery disease. Excess cholesterol forms fatty deposits in arteries, causing atherosclerosis, which narrows and hardens the arteries, increasing the risk of heart attack, angina, and stroke. Hypercholesterolemia typically has no symptoms, and the condition is diagnosed through a lipid profile test, which measures total cholesterol, LDL, HDL, and triglyceride levels.

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Hypercholesterolemia Treatment Analysis: Drug Profile
Tafolecimab: Innovent
Tafolecimab, developed by Innovent, is an IgG2 fully human monoclonal antibody that targets PCSK-9 to reduce LDL-C levels. By inhibiting PCSK-9-mediated endocytosis of low-density lipoprotein receptors (LDLR), it enhances the clearance of LDL-C from the bloodstream. This results in a reduction in LDL-C levels. In June 2022, Innovent Biologics announced that China's National Medical Products Administration (NMPA) had accepted the New Drug Application (NDA) for tafolecimab (IBI306), an anti-PCSK-9 antibody, for the treatment of primary hypercholesterolemia.

Ebronucimab: Akeso Biopharma
Ebronucimab (AK102) is a promising PCSK9 inhibitor developed by Akeso Biopharma, aimed at treating acquired and inherited hyperlipidemias, including HoFH, HeFH, and hypercholesterolemia in patients with atherosclerotic cardiovascular disease. Ebronucimab works similarly to other PCSK9 inhibitors like Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), significantly lowering cholesterol levels and reducing the risk of heart attacks and strokes. It has shown more robust pharmacodynamic and efficacy results compared to these marketed PCSK9 antibodies. Ebronucimab is poised to become the first domestically developed PCSK9 inhibitor in China, targeting a large population of cardiovascular patients.

Key Hypercholesterolemia Therapies and Companies
• Tafolecimab: Innovent
• Ebronucimab: Akeso Biopharma
• VERVE-101: Verve Therapeutics
• Lerodalcibep: LIB Therapeutics
• Zodasiran: Arrowhead Pharmaceuticals

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Hypercholesterolemia 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
• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

By Molecule Type
• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Scope of the Hypercholesterolemia Pipeline Report
• Coverage: Global
• Key Hypercholesterolemia Companies: Innovent, Akeso Biopharma, Ahn-Gook Pharmaceuticals Co., Ltd, Jiangsu Hengrui Medicine Co., Merck Sharp & Dohme LLC, Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Addpharma Inc., Verve Therapeutics, Inc., Novo Nordisk, NewAmsterdam Pharma, Vaxxinity, Nyrada, Sirnaomics, HighTide Biopharma, Luye Pharma, Shandong Boan Biotechnology, CiVi Biopharma, Precision biosciences, SalioGen Therapeutics, and others.
• Key Hypercholesterolemia Pipeline Therapies: Tafolecimab, Ebronucimab, AGT 2, SHR-1209, MK-0616, ARO-ANG 3, Lerodalcibep, PBGENE-PCSK9 candidate, CiVi 008, AD-221, VERVE-101, STP 135G, NNC 03850434, Obicetrapib, NYX 330, and others.

Dive deep into rich insights for drugs used for Hypercholesterolemia treatment; visit @ https://www.delveinsight.com/sample-request/hypercholesterolaemia-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. Hypercholesterolemia Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Hypercholesterolemia Pipeline Therapeutics
6. Hypercholesterolemia Pipeline: Late-Stage Products (Phase III)
7. Hypercholesterolemia Pipeline: Mid-Stage Products (Phase II)
8. Hypercholesterolemia 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

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