Hypercholesterolaemia - Pipeline Insight, 2025

This “Hypercholesterolaemia - Pipeline Insight, 2025,” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Hypercholesterolaemia 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.

Hypercholesterolaemia Understanding

Hypercholesterolaemia: Overview

Hypercholesterolemia is the term used to refer to a high blood cholesterol level. Cholesterol is a waxy substance that is produced by the liver and is a component of all cells found in the body. All of the cholesterol a person needs is produced in the liver, but another source is dietary cholesterol, which comes from animal food products such as meat, poultry, dairy, egg yolk and fish. Such foods are rich in saturated fats and Trans fats, substances that can trigger the liver to make an excess of cholesterol and in some cases, this can lead to hypercholesterolemia. Cholesterol is required for various bodily functions including the synthesis of cell membranes and certain hormones and the production of substances required for fat digestion. However, a cholesterol level that is too high can increase the risk of coronary artery disease. Excess cholesterol present in the blood forms fatty deposits in the walls of the coronary arteries, the blood vessels that supply the heart with blood. As the cholesterol accumulates, it causes atherosclerotic plaques to form, which narrow and harden the artery walls. This is referred to as atherosclerosis. Eventually, these plaques can block the arteries and limit the amount of oxygen-rich blood that can reach the heart. This increases a person’s risk of angina and heart attack. If the artery that supplies blood flow to the brain (carotid artery) becomes narrowed and hardened, then a person is at an increased risk of suffering a stroke. Hypercholesterolemia does not usually present with any symptoms and the only way to check for the condition is to perform a check of the blood cholesterol level, referred to as a lipid profile. This test typically includes a check of the total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level.

'Hypercholesterolaemia - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hypercholesterolaemia pipeline landscape is provided which includes the disease overview and Hypercholesterolaemia treatment guidelines. The assessment part of the report embraces, in depth Hypercholesterolaemia 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, Hypercholesterolaemia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Hypercholesterolaemia.

In the coming years, the Hypercholesterolaemia market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

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

A detailed portfolio of major pharma players who are involved in fueling the Hypercholesterolaemia treatment market. Several potential therapies for Hypercholesterolaemia are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Hypercholesterolaemia market size in the coming years.

Our in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Hypercholesterolaemia) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Hypercholesterolaemia Emerging Drugs Chapters

This segment of the Hypercholesterolaemia 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.

Hypercholesterolaemia Emerging Drugs

Tafolecimab: Innovent

Tafolecimab injection, developed by Innovent, is an lgG2 fully human monoclonal antibody that can specifically bind to PCSK-9 and reduce LDL-C level by inhibiting PCSK-9-mediated low-density lipoprotein receptor (LDLR) endocytosis, subsequently enhancing the clearance of LDL-C, resulting in a reduction in LDL-C level. In June 2022, Innovent Biologics announced that the China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection (anti-PCSK-9 antibody, R&D code: IBI306) for the treatment of primary hypercholesterolemia

• Ebronucimab: Akeso Biopharma

Ebronucimab (AK102) is potentially going to be the first domestically-developed PCSK9 drug candidate marketed to the significant cardiovascular patient population in China. Ebronucimab (AK102) is being developed for the treatment of acquired and inherited hyperlipidemias, including HoFH, HeFH, and hypercholesterolemias patients with atherosclerotic cardiovascular disease. When used in addition to or in the place of statin drugs, PCSK9 inhibitors (Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab)) have demonstrated efficacy in dramatically reducing cholesterol and decreasing the incidence of heart attack or stroke in patients. Ebronucimab (AK102) has the same target as evolocumab and alirocumab. According to Frost & Sullivan, Repatha (evolocumab) and Praluent (alirocumab) collectively experienced a rapid increase in global sales from US$20 million in 2015, when they were launched, to US$858 million in 2018, representing a CAGR of 250.2%.Ebronucimab (AK102) has exhibited more robust results in pharmacodynamic and efficacy aspects compared to marketed PCSK9 antibody drug.

Hypercholesterolaemia: Therapeutic Assessment

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

Major Players in Hypercholesterolaemia

There are approx. 25+ key companies which are developing the therapies for Hypercholesterolaemia. The companies which have their Hypercholesterolaemia drug candidates in the most advanced stage, i.e. preregistration include, Innovent.

Phases

The report covers around 25+ 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

Hypercholesterolaemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

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

Molecule Type

Products have been categorized under various Molecule types such as

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

Product Type

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

Hypercholesterolaemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hypercholesterolaemia 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 Hypercholesterolaemia drugs.

Hypercholesterolaemia Report Insights

• Hypercholesterolaemia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hypercholesterolaemia 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 Hypercholesterolaemia drugs?
• How many Hypercholesterolaemia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hypercholesterolaemia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hypercholesterolaemia 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 Hypercholesterolaemia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• 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

This product will be delivered within 1-3 business days.