Severe hypertriglyceridemia is a condition characterized by extremely high triglyceride levels, typically exceeding 500 mg/dL, posing serious risks such as pancreatitis and cardiovascular complications. It accounts for a significant share of lipid disorders, with about one-third of U.S. adults exhibiting elevated triglyceride levels. The severe hypertriglyceridemia pipeline analysis by Expert Market Research highlights ongoing advancements in biologics and gene-targeted therapies. Rising awareness, improved diagnostics, and investment in R&D are expected to drive the growth of severe hypertriglyceridemia therapeutics in the coming years.
Report Coverage
The Severe Hypertriglyceridemia Pipeline Analysis Report by Expert Market Research gives comprehensive insights into severe hypertriglyceridemia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Severe Hypertriglyceridemia. The severe hypertriglyceridemia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The severe hypertriglyceridemia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with severe hypertriglyceridemia treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to severe hypertriglyceridemia.
Severe Hypertriglyceridemia Pipeline Outlook
Severe hypertriglyceridemia is a condition characterized by extremely high levels of triglycerides in the blood, often exceeding 1,000 mg/dL. It occurs due to genetic factors, uncontrolled diabetes, obesity, excessive alcohol intake, or certain medications. This condition can lead to life-threatening complications, such as acute pancreatitis, when not properly managed.
Severe hypertriglyceridemia treatment includes triglyceride-lowering medications, strict dietary fat restrictions, and lifestyle changes. Fibrates, omega-3 fatty acids, and statins are commonly prescribed to reduce triglyceride levels and prevent complications. In December 2024, Olezarsen (Tryngolza), an antisense oligonucleotide, became the first FDA-approved drug for familial chylomicronemia syndrome, significantly lowering triglycerides and reducing pancreatitis risk in affected adults.
Severe Hypertriglyceridemia Epidemiology
Severe hypertriglyceridemia affects approximately 1 in 600 individuals in the United States, with about 2.3 million adults having triglyceride levels ≥500 mg/dL. Its prevalence is higher among men aged 40-60 years and Hispanic populations. Around 70.3% of affected individuals have central obesity, and 29.3% present with multiorgan disease. Compared to those with triglycerides <200 mg/dL, the adjusted prevalence ratio for multiorgan disease is 2.95 in severe cases.
Severe Hypertriglyceridemia – Pipeline Therapeutic Assessment
This section of the report covers the analysis of severe hypertriglyceridemia drug candidates based on several segmentations, including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Small Molecules
- Antisense Oligonucleotides
- siRNA
- Monoclonal Antibodies
- Gene Therapies
- Others
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase III holds the largest share at 90%, showcasing strong late-stage development in the severe hypertriglyceridemia pipeline. Phase II accounts for 10%, indicating continued innovation and progress. The dominance of advanced clinical phases reflects a promising landscape that may lead to effective treatments, positively impacting market growth and improving patient outcomes.
Severe Hypertriglyceridemia Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the severe hypertriglyceridemia pipeline analysis include small molecules, antisense oligonucleotides, siRNA, monoclonal antibodies, gene therapies, and others. The severe hypertriglyceridemia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for severe hypertriglyceridemia.
RNA-based drug therapies are emerging as a novel approach in the severe hypertriglyceridemia pipeline. For instance, Lipisense, a liver-specific RNA therapeutic developed by Lipigon Pharmaceuticals, is currently in Phase II clinical trials. It targets angiopoietin-like 4 (ANGPTL4) to enhance triglyceride clearance, offering potential benefits for patients with severe lipid imbalances and type 2 diabetes.
Severe Hypertriglyceridemia Clinical Trials – Key Players
The EMR report for the severe hypertriglyceridemia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed severe hypertriglyceridemia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in severe hypertriglyceridemia clinical trials:
- Ionis Pharmaceuticals, Inc.
- Arrowhead Pharmaceuticals
- 89bio, Inc.
- Zhejiang Doer Biologics Co., Ltd.
- AstraZeneca
- Kowa Research Institute, Inc.
- Regeneron Pharmaceuticals
- Mochida Pharmaceutical Company, Ltd.
- Arisaph Pharmaceuticals Inc.
- Grace Therapeutics Inc.
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for severe hypertriglyceridemia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of severe hypertriglyceridemia drug candidates.
Drug: Olezarsen
Olezarsen is currently being evaluated in a Phase III trial sponsored by Ionis Pharmaceuticals, Inc. for patients with severe hypertriglyceridemia (sHTG). Olezarsen is a ligand-conjugated antisense (LICA) RNA-targeted therapy that inhibits apoC-III production, a key regulator of triglyceride metabolism. This study is assessing the efficacy of subcutaneous Olezarsen versus placebo in reducing fasting triglyceride levels.
Drug: Plozasiran Injection
Plozasiran is being sponsored by Arrowhead Pharmaceuticals for a Phase III study (SHASTA-4) to evaluate its safety and efficacy in adults with severe hypertriglyceridemia (SHTG). The study is assessing whether Plozasiran, an RNA interference (RNAi) therapeutic targeting APOC3, can significantly lower triglyceride levels by inhibiting its production and restoring lipid balance.
Drug: DR10624 Injection
DR10624 is a long-acting Fc fusion protein tri-agonist developed by Zhejiang Doer Biologics Co., Ltd. It targets GLP-1R, GCGR, and FGF21R receptors for metabolic improvement. This Phase II study is evaluating its efficacy and safety in treating severe hypertriglyceridemia (SHTG). The trial is examining how DR10624 reduces fasting serum triglyceride levels over 12 weeks.
Key Questions Answered in the Severe Hypertriglyceridemia Pipeline Analysis Report
- Which companies/institutions are leading the severe hypertriglyceridemia drug development?
- What is the efficacy and safety profile of severe hypertriglyceridemia pipeline drugs?
- Which company is leading the severe hypertriglyceridemia pipeline development activities?
- What is the current severe hypertriglyceridemia commercial assessment?
- What are the opportunities and challenges present in the severe hypertriglyceridemia pipeline landscape?
- What is the efficacy and safety profile of severe hypertriglyceridemia pipeline drugs?
- Which company is conducting major trials for severe hypertriglyceridemia drugs?
- Which companies/institutions are involved in severe hypertriglyceridemia collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in severe hypertriglyceridemia?
The Severe Hypertriglyceridemia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for severe hypertriglyceridemia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into severe hypertriglyceridemia collaborations, regulatory environments, and potential growth opportunities.
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- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Severe Hypertriglyceridemia
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Severe Hypertriglyceridemia
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Severe Hypertriglyceridemia: Epidemiology Snapshot
- 5.1 Severe Hypertriglyceridemia Incidence by Key Markets
- 5.2 Severe Hypertriglyceridemia – Patients Seeking Treatment in Key Markets
- 6 Severe Hypertriglyceridemia: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Severe Hypertriglyceridemia: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Severe Hypertriglyceridemia, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Severe Hypertriglyceridemia Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Severe Hypertriglyceridemia Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: Olezarsen
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Drug: Plozasiran Injection
- 10.2.3 Drug: Pegozafermin
- 10.2.4 Other Drugs
- 11 Severe Hypertriglyceridemia Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: DR10624 Injection
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Other Drugs
- 12 Severe Hypertriglyceridemia Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug 1
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Other Drugs
- 13 Severe Hypertriglyceridemia Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Severe Hypertriglyceridemia, Key Drug Pipeline Companies
- 14.1 Ionis Pharmaceuticals, Inc.
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 Arrowhead Pharmaceuticals
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 89bio, Inc.
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 Zhejiang Doer Biologics Co., Ltd.
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 AstraZeneca
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 Kowa Research Institute, Inc.
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 Regeneron Pharmaceuticals
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 14.8 Mochida Pharmaceutical Company, Ltd.
- 14.8.1 Company Snapshot
- 14.8.2 Pipeline Product Portfolio
- 14.8.3 Financial Analysis
- 14.8.4 Recent News and Developments
- 14.9 Arisaph Pharmaceuticals Inc.
- 14.9.1 Company Snapshot
- 14.9.2 Pipeline Product Portfolio
- 14.9.3 Financial Analysis
- 14.9.4 Recent News and Developments
- 14.10 Grace Therapeutics Inc.
- 14.10.1 Company Snapshot
- 14.10.2 Pipeline Product Portfolio
- 14.10.3 Financial Analysis
- 14.10.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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