VivoSeq
Metabolic & Endocrine

Hypercholesterolemia

108

Pipeline Programs↗

17

Active Trials↗

48

Companies Involved↗

Hypercholesterolemia is a highly competitive landscape with 108 programs across 48 companies. The most active players are Regeneron, Aegerion Pharmaceuticals, Inc., Innovent Biologics (Suzhou) Co. Ltd.. 19 therapies are approved with 48 more in late-stage development.

Intelligence

Pipeline Metrics

Competitive Density

71/100

Pipeline Velocity

25/100

Mech. Concentration

42/100

Completion Rate

86/100

Attrition Rate

12/100

Competition

Competitive Landscape

Bubble size = clinical trials

Approved
Phase 3
Phase 2
Phase 1
Preclinical

Key Players

Top Companies Companies ranked by the number of pipeline programs they run for this disease.

Regeneron logo

Regeneron

2 programs

Phase 2A

Aegerion Pharmaceuticals, Inc.

2 programs

Phase 2Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.

1 program

Phase 2Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.

1 program

Phase 2G

Golden Biotechnology Corporation

1 program

Phase 2H

HighTide Biopharma Pty Ltd

1 program

Phase 2

Pipeline

Programs by Phase

Preclinical9

Volanesorsen

Akcea Therapeutics

Ezetimibe

Organon and Co

Atorvastatin Calcium

Merck & Co.

Evolocumab

Amgen

Amoxicillin

Global Antibiotics Research and Development Partnership

Phase 18

MK0859

Merck & Co.

LGT209

Novartis

PF-04950615

Pfizer

Test Drug

Chong Kun Dang Pharmaceutical

Reference Drug

Chong Kun Dang Pharmaceutical

Phase 224

Alirocumab

Regeneron

Antroquinonol

Golden Biotechnology Corporation

HTD1801

HighTide Biopharma Pty Ltd

SCH 56592

Merck & Co.

BMS-201038 (AEGR-733)

Aegerion Pharmaceuticals, Inc.

Phase 348

Evacetrapib

Eli Lilly

Statin

Bristol-Myers Squibb

Irbesartan

Sanofi

Lipid-Modifying Therapy (LMT)

Sanofi

Telmisartan

Boehringer Ingelheim

Approved19

Pravastatin

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Inclisiran

Novartis

Lovastatin

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Bempedoic Acid

Esperion Therapeutics, Inc.

Niacin

AbbVie

Analysis

Modality Breakdown

94%

Small molecule

118 of 126 classified programs — the dominant modality here.

6%ALL OTHERSMonoclonal antibody43%RNA therapy32%Peptide1<1%

Small molecule leads; the ring shows all 126 classified programs, each share of the total. Modality classified for 99% of 131 pipeline programs.

Analysis

Trial Status

194

clinical trials

Completed144 · 74%
Terminated19 · 10%
Unknown status9 · 5%
Active, not recruiting7 · 4%
Not yet recruiting6 · 3%
Withdrawn5 · 3%
Other4 · 2%

Clinical Trials

Trial Activity

194 trials

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
Recruiting·HHasten Biopharmaceutical Co., Ltd.·Phase 3·NCT06568471·210 enrolled
A Post-Marketing Clinical Trial of Pemafibrate in Patients With Hypercholesterolemia and Inadequate Response to Statins-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial
Recruiting·KKowa Company, Ltd.·Approved·NCT07634484·120 enrolled
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
Recruiting·Regeneron logoRegeneron·Phase 2·NCT07477704·420 enrolled
Disease Pathogenesis and Natural History of Lipid Disorders
Recruiting·National Heart, Lung, and Blood Institute (NHLBI)·N/A·NCT00353782·2,000 enrolled
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Active, not recruiting·Merck & Co. logoMerck & Co.·Phase 3·NCT06492291·3,000 enrolled
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Active, not recruiting·Daiichi Sankyo logoDaiichi Sankyo·N/A·NCT04579367·5,000 enrolled
Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides
Active, not recruiting·JJW Pharmaceutical·Phase 4·NCT07442630·88 enrolled
ORION-9 Extension: Inclisiran in Familial HC
Active, not recruiting·Novartis logoNovartis·Phase 3·NCT05400005·1,800 enrolled
ORION-18: Inclisiran Long-Term in Hypercholesterolemia
Active, not recruiting·Novartis logoNovartis·Phase 3·NCT04755907·3,200 enrolled
FALCON-1: Inclisiran in Statin-Intolerant Patients
Active, not recruiting·Novartis logoNovartis·Phase 3·NCT06700009·600 enrolled
WAYLIVRA-LT: Volanesorsen Long-Term Extension
Active, not recruiting·Ionis Pharmaceuticals logoIonis Pharmaceuticals·Phase 3·NCT05700007·110 enrolled
Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients
Not yet recruiting·SSuzhou Municipal Hospital·Phase 1·NCT06293729·9 enrolled
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Not yet recruiting·Qilu Pharmaceutical Co., Ltd. logoQilu Pharmaceutical Co., Ltd.·Phase 3·NCT07441317·780 enrolled
A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
Not yet recruiting·BBeijing Suncadia Pharmaceuticals Co., Ltd·Phase 2/3·NCT07404553·126 enrolled
DNV001 Injection in Patients With Hypercholesterolemia
Not yet recruiting·HHangzhou Dinovate Biotech Co., Ltd·Phase 2·NCT07391722·120 enrolled
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Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)