Hypercholesterolemia- Pipeline Insight, 2025

DelveInsight’s, “Hypercholesterolemia- Pipeline Insight, 2025” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in Hypercholesterolemia 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

Hypercholesterolemia: Understanding

Hypercholesterolemia: Overview

Hypercholesterolemia is a specific type of hyperlipidemia. Hypercholesterolemia can be defined as a LDL-cholesterol greater than 190 mg/dL, greater than 160 mg/dL with one major risk factor, or greater than 130 mg/dL with two cardiovascular risk factors. Hypercholesterolemia can be inherited, but it's often the result of unhealthy lifestyle choices, which make it preventable and treatable. A healthy diet, regular exercise and sometimes medication can help reduce high cholesterol. Increases the risk of heart disease. Elevated levels of circulating cholesterol cause deposits to form inside blood vessels. These deposits, called plaque, are composed of fats deposited from the bloodstream. When the deposits become sufficiently large, they block blood vessels and decrease the flow of blood. These deposits result in a disease process called atherosclerosis, which can cause blood clots to form that will ultimately stop blood flow.

Although hypercholesterolemia is asymptomatic in and of itself, a long-term increase in serum cholesterol can lead to atherosclerosis (hardening of arteries). Elevated serum cholesterol contributes to the production of atheromatous plaques in the arteries over decades. This can cause the arteries involved to constrict over time. Smaller plaques, on the other hand, may rupture and form a clot, obstructing blood flow. Tissue ischemia (restricted blood supply) may emerge as distinct symptoms at this time. Momentary ischemia of the brain (also known as a transient ischemic attack) can cause temporary vision loss, dizziness, and impairment of balance, trouble speaking, weakness, or numbness or tingling on one side of the body.

In the United States and certain other nations, cholesterol is measured in milligrammes per deciliter (mg/dL) of blood. Millimoles per litre of blood (mmol/Ll) is the unit of measurement in the United Kingdom, most European countries, and Canada. Total cholesterol should not exceed 5 mmol/L, and low-density lipoprotein cholesterol (LDL) should not exceed 3 mmol/L, according to the UK National Health Service. Total cholesterol should not exceed 4 mmol/L, and LDL should not exceed 2 mmol/L in persons at high risk of cardiovascular disease. There is no absolute cutoff between normal and abnormal cholesterol levels, thus values must be interpreted in light of other health conditions and risk factors. If hypercholesterolemia is inherited (familial hypercholesterolemia), a family history of premature, early-onset atherosclerosis is more likely to be discovered. The cornerstone of treatment of hypercholesterolemia is a healthy lifestyle, an optimum weight, no smoking, exercising for 150 minutes per week, and a diet low in saturated and trans-fatty acids and enriched in fiber, fruit, and vegetables and fatty fish. Plant stanols at a dose of 2 g/d can help reduce LDL-C levels. The drug class of choice is the statin which can lower LDL-C from 22% to 50%. Also, they have been shown to reduce cardiovascular events in both primary and secondary prevention trials.

""Hypercholesterolemia- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hypercholesterolemia pipeline landscape is provided which includes the disease overview and Hypercholesterolemia treatment guidelines. The assessment part of the report embraces, in depth Hypercholesterolemia 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, Hypercholesterolemia 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 Hypercholesterolemia R&D. The therapies under development are focused on novel approaches to treat/improve Hypercholesterolemia.

Hypercholesterolemia Emerging Drugs Chapters

This segment of the Hypercholesterolemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

Hypercholesterolemia Emerging Drugs

• SHR-1209: Jiangsu HengRui Medicine Co., Ltd.

Recaticimab (SHR-1209) represents an innovative and novel approach in cardiovascular therapeutics as a long-acting monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Specifically, it belongs to the immunoglobulin G1 (IgG1) class, showing its distinctiveness in modulating PCSK9 activity and contributing to the expanding landscape of therapeutic interventions for hyperlipidemia and cardiovascular health. Currently the drug is in Preregistration stage for the treatment of Hypercholesterolemia.

• MK-0616: Merck Sharp & Dohme LLC

MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol. Discovered and developed by Merck, MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. MK-0616 is being developed under an agreement with UCB Pharmaceuticals. Results from the Phase IIb clinical trial evaluating MK-0616 showed that MK-0616 was generally well-tolerated with no overall trends across treatment groups in discontinuation rates or adverse events at week 16. No serious adverse events that were considered by the investigator to be related to treatment with MK-0616 were reported. Currently the drug is in Phase III stage for the treatment of Hypercholesterolemia.

• ARO-ANG 3: Arrowhead Pharmaceuticals

ARO-ANG3 is an investigational RNAi therapeutic designed to reduce expression of angiopoietin-like protein 3 (ANGPTL3), a hepatocyte expressed regulator of lipid and lipoprotein metabolism with multiple potential modes of action, including inhibition of lipoprotein lipase and endothelial lipase. Given the inhibitory role of ANGPTL3 in the metabolism of various lipoproteins and triglycerides, reduced expression and reduced circulating levels of ANGPTL3 may increase clearance of LDL-cholesterol, HDL-cholesterol, and triglycerides. Currently the drug is in Phase II stage for the treatment of Hypercholesterolemia.

• VXX-401: Vaxxinity, Inc.

VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform and is being developed for the treatment of hypercholesterolemia. The platform is designed to harness the immune system to convert the body into its own natural “drug factory,” stimulating the production of antibodies. VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 and lower LDL cholesterol to prevent or treat coronary heart disease. Currently the drug is in Phase I stage for the treatment of Hypercholesterolemia.

Further product details are provided in the report……..

Hypercholesterolemia: Therapeutic Assessment

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

• Major Players in Hypercholesterolemia

There are approx. 25+ key companies which are developing the therapies for Hypercholesterolemia. The companies which have their Hypercholesterolemia drug candidates in the most advanced stage, i.e. Preregistration include, Jiangsu HengRui Medicine Co., Ltd.

• Phases

DelveInsight’s report covers around 30+ 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

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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

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

Hypercholesterolemia: Pipeline Development Activities

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

Hypercholesterolemia Report Insights

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

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

Key Players

• Jiangsu HengRui Medicine Co., Ltd.
• Merck Sharp & Dohme LLC
• Arrowhead Pharmaceuticals
• Vaxxinity, Inc.
• Akeso Biopharma
• Haisco Pharmaceutical Group Co., Ltd.
• Verve Therapeutics, Inc.
• Amytrx Therapeutics
• EPIC BIO
• Addpharma
• NewAmsterdam Pharma
• LIB Therapeutics

Key Products

• SHR-1209
• MK-0616
• ARO-ANG 3
• VXX-401
• Ebronucimab
• HSK31679
• VERVE-101
• AMTX 100
• EPIC-221
• AD 2022
• Ezetimibe/obicetrapib
• Lerodalcibep