Hypercholesterolemia Pipeline 2025: Innovative Clinical Advancements by 25+ Global Leaders - DelveInsight | Featuring companies such as Jiangsu HengRui Medicine Co., Ltd., Merck Sharp & Dohme LLC, Arr

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.
With hypercholesterolemia reaching global epidemic proportions and contributing to comorbid conditions such as diabetes, cardiovascular disease, and certain cancers, the demand for safer and more effective treatments is rising. DelveInsight reports that the hypercholesterolemia pipeline comprises 25+ pharmaceutical and biotech companies developing more than 30 therapeutic candidates. These therapies are in various stages of clinical and preclinical development, reflecting significant innovation and dedication to tackling this major health challenge.

The report, "Hypercholesterolemia Pipeline Insight 2025," provides a thorough evaluation of the current R&D landscape, covering clinical trial progression, emerging therapies, mechanisms of action, competitive landscape, and key company initiatives. It serves as a vital resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving hypercholesterolemia therapeutics market and the breakthroughs shaping its future.

Explore the Cutting-Edge Landscape of Hypercholesterolemia Drug Development @ https://www.delveinsight.com/report-store/hypercholesterolemia-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:

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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).

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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.

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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).

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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.

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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.

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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER Trademark program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.

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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.

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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT Trademark study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.

Key Takeaways from the Hypercholesterolemia Pipeline Report

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DelveInsight's Hypercholesterolemia pipeline report highlights a dynamic landscape with 25+ active companies developing over 30 therapeutic candidates for the treatment of hypercholesterolemia.

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In February 2025, the U.S. FDA accepted Ultragenyx Pharmaceutical's Biologics License Application (BLA) for UX111 (ABO-302), an AAV-based gene therapy targeting Hypercholesterolemia Type A. The application received Priority Review, shortening the decision timeline to six months, with a Prescription Drug User Fee Act (PDUFA) action date set for August 125, 2025.

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Denali Therapeutics' DNL126, an investigational enzyme replacement therapy designed to cross the blood-brain barrier, was selected for the FDA's START (Support for Clinical Trials Advancing Rare Disease Therapeutics) pilot program, aimed at accelerating the development of novel rare disease treatments.

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Leading companies in the hypercholesterolemia space-including 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, and others-are actively pursuing new therapies to advance treatment options.

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Promising pipeline candidates under development include SHR-1209, MK-0616, ARO-ANG 3, VXX-401, and several others.

Hypercholesterolemia Overview:

Hypercholesterolemia is a type of hyperlipidemia marked by elevated levels of LDL cholesterol. Diagnosis is generally made when LDL levels exceed 190 mg/dL, or 160 mg/dL with one major cardiovascular risk factor, or 130 mg/dL with two risk factors. While it can have a genetic basis, hypercholesterolemia is often associated with unhealthy lifestyle habits, making it largely preventable and manageable. Dietary improvements, regular exercise, and medications can help reduce cholesterol levels.

Elevated cholesterol increases the risk of heart disease by promoting the formation of plaques in the blood vessels. These plaques, composed of fat and cholesterol, can narrow arteries or cause blockages, leading to atherosclerosis and potentially life-threatening blood clots.

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Hypercholesterolemia Pipeline Analysis

The Hypercholesterolemia pipeline insights report 2025, provides insights into:

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Provides comprehensive insights into key companies developing therapies in the Hypercholesterolemia Market.

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Categorizes Hypercholesterolemia therapeutic companies by development stage: early, mid, and late-stage.

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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

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Reviews emerging Hypercholesterolemia drugs under development based on:

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Stage of development

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Hypercholesterolemia Route of administration

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Target receptor

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Monotherapy vs. combination therapy

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Hypercholesterolemia Mechanism of action

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Molecular type

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Offers detailed analysis of:

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Company-to-company and company-academia collaborations

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Hypercholesterolemia Licensing agreements

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Funding and investment activities supporting future Hypercholesterolemia market advancement.

Unlock key insights into emerging Hypercholesterolemia therapies and market strategies here: https://www.delveinsight.com/report-store/hypercholesterolemia-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Hypercholesterolemia Emerging Drugs

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

Recaticimab (SHR-1209) is an innovative long-acting IgG1 monoclonal antibody that targets PCSK9. This therapy offers a novel approach for managing hyperlipidemia and cardiovascular diseases by inhibiting PCSK9, a crucial protein in cholesterol regulation. Recaticimab is currently in the preregistration stage for the treatment of hypercholesterolemia.

MK-0616: Merck Sharp & Dohme LLC

MK-0616 is an oral PCSK9 inhibitor being studied for its ability to reduce LDL cholesterol. This macrocyclic peptide prevents PCSK9 from interacting with LDL receptors. Developed by Merck in collaboration with UCB Pharmaceuticals, MK-0616 demonstrated a favorable safety and tolerability profile in Phase IIb trials, with no serious treatment-related adverse events reported. The therapy has now progressed to Phase III development for hypercholesterolemia.

ARO-ANG3: Arrowhead Pharmaceuticals

ARO-ANG3 is an RNA interference (RNAi) therapy aimed at silencing ANGPTL3, a liver-produced protein involved in lipid regulation. By inhibiting ANGPTL3, ARO-ANG3 has the potential to lower LDL cholesterol, HDL cholesterol, and triglyceride levels. The drug is currently in Phase II clinical development for hypercholesterolemia.

VXX-401: Vaxxinity, Inc.

VXX-401 is a synthetic peptide vaccine designed to treat hypercholesterolemia by stimulating the immune system to produce antibodies against PCSK9. This strategy aims to achieve sustained lowering of LDL cholesterol. The therapy is currently in Phase I clinical trials.

Hypercholesterolemia Pipeline Therapeutic Assessment

Hypercholesterolemia Assessment by Product Type

- Mono

- Combination

- Mono/Combination

Hypercholesterolemia 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

Hypercholesterolemia Assessment by Route of Administration

- Oral

- Parenteral

- Intravenous

- Subcutaneous

- Topical

Hypercholesterolemia Assessment by Molecule Type

- Recombinant fusion proteins

- Small molecule

- Monoclonal antibody

- Peptide

- Polymer

- Gene therapy

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Table of Contents

1. Report Introduction

2. Executive Summary

3. Hypercholesterolemia Current Treatment Patterns

25. Hypercholesterolemia - DelveInsight's Analytical Perspective

5. Therapeutic Assessment

30. Hypercholesterolemia Late-Stage Products (Phase-III)

7. Hypercholesterolemia Mid-Stage Products (Phase-II)

25. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

30. Inactive Products

11. Dormant Products

12. Hypercholesterolemia Discontinued Products

13. Hypercholesterolemia Product Profiles

125. Hypercholesterolemia Key Companies

15. Hypercholesterolemia Key Products

130. Dormant and Discontinued Products

17. Hypercholesterolemia Unmet Needs

125. Hypercholesterolemia Future Perspectives

19. Hypercholesterolemia Analyst Review

20. Appendix

21. Report Methodology

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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