Severe Hypertriglyceridemia - Pipeline Insight, 2025

DelveInsight's, "Severe Hypertriglyceridemia - Pipeline Insight, 2025" report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Severe Hypertriglyceridemia 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

Severe Hypertriglyceridemia: Understanding

Severe Hypertriglyceridemia: Overview

Severe Hypertriglyceridemia (HTG) is a condition characterized by significantly elevated levels of triglycerides in the blood, which increases the risk of both Cardiovascular Disease (CVD) and pancreatitis. While statin therapy has proven effective in managing low-density Lipoprotein Cholesterol (LDL-C) levels and improving outcomes for Atherosclerotic Cardiovascular Disease (ASCVD), residual cardiovascular risk remains, particularly in patients with mild to moderate HTG. Despite the association of hypertriglyceridemia with CVD, evidence on whether treating HTG directly reduces cardiovascular risk is still inconclusive. Emerging therapies such as omega-3 fatty acids, fibrates, and novel agents targeting apolipoprotein C-III and angiopoietin-like protein 3 (ANGPTL3) are being explored for their triglyceride-lowering effects. Genetic predisposition, metabolic syndrome, and poorly controlled diabetes often contribute to elevated triglyceride levels. Early identification and a tailored therapeutic approach are essential to reduce the risk of both acute pancreatitis and long-term cardiovascular complications.

Severe hypertriglyceridemia often presents with no noticeable symptoms, but when triglyceride levels are extremely elevated, various signs may occur. These include skin changes like xanthomas, abdominal pain, nausea, and vomiting. In severe cases, it can lead to acute pancreatitis, liver and spleen swelling, and corneal arcus. Neurological symptoms such as short-term memory loss, difficulty breathing (dyspnea), and even depression or dementia may also be seen, particularly in conditions like chylomicronemia syndrome. Skin flushing after alcohol consumption is another common sign. Additional manifestations may include lipemia retinalis-a milky appearance of retinal blood vessels-and a creamy layer in plasma known as a "lipemic plasma" appearance. Patients may also experience fatigue or irritability due to metabolic imbalances. In children, growth delays or failure to thrive may be an early sign of genetic lipid disorders.

Triglycerides are carried in the blood by lipoproteins like VLDL and chylomicrons. Chylomicrons, released from the small intestine, carry triglycerides which are broken down into free fatty acids (FFAs) for energy or storage. The remnants of triglyceride-rich lipoproteins can contribute to plaque formation due to their cholesterol content, and the breakdown of triglycerides produces reactive lipids that promote inflammation and clotting. Excess triglycerides, especially above 500 mg/dL, can lead to pancreatitis by causing chylomicron buildup in the pancreas, leading to inflammation. Keeping triglyceride levels below 250-500 mg/dL can help prevent pancreatitis. Additionally, insulin resistance impairs lipoprotein lipase activity, leading to reduced clearance of triglyceride-rich particles. Genetic mutations in apolipoproteins or enzymes like LPL can also contribute to persistent elevations in triglycerides. The resulting lipid imbalance can further disrupt endothelial function and promote oxidative stress. These mechanisms collectively heighten the risk for both atherogenesis and metabolic complications.

Treatment of severe hypertriglyceridemia involves a combination of lifestyle changes and medications. Intravenous fluids, bowel rest, and insulin infusion are used during acute pancreatitis episodes, with plasmapheresis considered for extremely high triglyceride levels. Fibrates are the first-line treatment, reducing triglycerides by 30-50% and improving HDL-C, though they require dose adjustments in those with kidney disease. Omega-3 fatty acids are FDA-approved for severe cases, reducing triglycerides by up to 50%. Niacin and statins also lower triglycerides, but their use is less common due to side effects and limited cardiovascular benefits. The goal is to reduce triglycerides below 500 mg/dL to lower the risk of pancreatitis and cardiovascular disease. Emerging therapies like angiopoietin-like protein 3 (ANGPTL3) and apolipoprotein C-III (apoC-III) inhibitors show promise in genetically driven hypertriglyceridemia. Strict glycemic control in diabetic patients can also significantly lower triglyceride levels. Regular monitoring and patient education are essential for long-term management and preventing recurrence.

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

Severe Hypertriglyceridemia Emerging Drugs Chapters

This segment of the Severe Hypertriglyceridemia report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

Severe Hypertriglyceridemia Emerging Drugs

• Plozasiran: Arrowhead Pharmaceuticals

Plozasiran (ARO-APOC3) is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of Apolipoprotein C-III (APOC3), which is a component of Triglyceride Rich Lipoproteins (TRLs) and a key regulator of triglyceride metabolism. APOC3 increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of APOC3, thereby reducing triglycerides and restoring lipids to more normal levels. Currently, the drug is in the Phase III stage of its development for the treatment of Severe Hypertriglyceridemia.

• Pegozafermin: 89bio, Inc.

Pegozafermin is an investigational FGF21 analog engineered using glycoPEGylation technology with site-specific mutations designed to recapitulate the activity profile and prolong the half-life of the native FGF21 hormone, which may address underlying metabolic issues that drive liver and cardiometabolic diseases, such as MASH and SHTG. FGF21 is an endogenous hormone that has broad effects such as regulating energy expenditure, glucose and lipid metabolism. Currently, the drug is in Phase III stage of its development for the treatment of Severe Hypertriglyceridemia.

• DR10624: Zhejiang Doer Biologics Co., Ltd.

DR10624 is a first-in-class long-acting tri-agonist targeting FGF21R, GLP-1R, and glucagon receptor (GCGR). Developed using Doer Bio's proprietary MultipleBody(R) platform technology, DR10624 was engineered to exhibit balanced activity for metabolic diseases. In non-clinical studies, DR10624 has demonstrated extraordinary potency in reducing body weight, lowering triglycerides, normalizing blood lipids, and improving liver function. Currently, the drug is in Phase II stage of its development for the treatment of Severe Hypertriglyceridemia.

Severe Hypertriglyceridemia: Therapeutic Assessment

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

• Major Players in Severe Hypertriglyceridemia
• There are approx. 8+ key companies which are developing the therapies for Severe Hypertriglyceridemia. The companies which have their Severe Hypertriglyceridemia drug candidates in the most advanced stage, i.e. Phase III include, Arrowhead Pharmaceuticals.
• Phases

DelveInsight's report covers around 10+ 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

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Severe Hypertriglyceridemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Severe Hypertriglyceridemia 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 Severe Hypertriglyceridemia drugs.

Severe Hypertriglyceridemia Report Insights

• Severe Hypertriglyceridemia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Arrowhead Pharmaceuticals
• 89bio, Inc.
• Zhejiang Doer Biologics Co., Ltd.
• OrsoBio, Inc
• Onconic Therapeutics
• Mammoth Biosciences, Inc.

Key Products

• Plozasiran
• Pegozafermin
• DR10624
• TLC-2716
• STX 1400
• MB-111