Skip to main content

Hypercholesterolemia

120
Pipeline Programs
30
Companies
50
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
25
1
24
0
47
23
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
4062%
Monoclonal Antibody
1625%
RNA Therapeutic
711%
Peptide
23%
+ 137 programs with unclassified modality

On Market (3)

Approved therapies currently available

AstraZeneca
CRESTORApproved
rosuvastatin
AstraZeneca
oral2003
39M Part D
Merck & Co.
ZETIAApproved
ezetimibe
Merck & Co.
Dietary Cholesterol Absorption Inhibitor [EPC]oral2002
7M Part D
Pfizer
CADUETApproved
amlodipine and atorvastatin
Pfizer
oral2004
222K Part D

Competitive Landscape

49 companies ranked by most advanced pipeline stage

MSD
MSDIreland - Ballydine
32 programs
5
4
15
5
Ezetimibe + AtorvastatinPhase 4Small Molecule1 trial
Ezetimibe + SimvastatinPhase 4Small Molecule1 trial
Ezetimibe + StatinPhase 4Small Molecule1 trial
RosuvastatinPhase 4Small Molecule1 trial
SimvastatinPhase 4Small Molecule1 trial
+27 more programs
Active Trials
NCT01228019Terminated1,166Est. May 2013
NCT06960655Enrolling By Invitation300Est. Nov 2026
NCT00704314Completed20Est. Jul 2005
+29 more trials
Sharp Therapeutics
5
4
15
5
Ezetimibe + AtorvastatinPhase 4Small Molecule
Ezetimibe + SimvastatinPhase 4Small Molecule
Ezetimibe + StatinPhase 4Small Molecule
RosuvastatinPhase 4Small Molecule
SimvastatinPhase 4Small Molecule
+27 more programs
Merck & Co.
Merck & Co.RAHWAY, NJ
8 programs
1
EzetimibeN/A1 trial
MK-0616PHASE_1
MK0859PHASE_1
Vytorin + NiaspanPHASE_1
MK0859PHASE_2
+3 more programs
Active Trials
NCT00908011Completed43Est. Jan 2015
Sandoz
SandozAustria - Kundl
7 programs
2
1
2
2
Inclisiran SodiumPhase 4RNA Therapeutic1 trial
Inclisiran sodiumPhase 4RNA Therapeutic1 trial
InclisiranPhase 3RNA Therapeutic1 trial
inclisiran sodiumPhase 3RNA Therapeutic1 trial
Inclisiran sodiumPhase 2RNA Therapeutic1 trial
+2 more programs
Active Trials
NCT01979601Completed74Est. Nov 2011
NCT01859455Completed25Est. Jul 2012
NCT04666298Completed312Est. Oct 2022
+4 more trials
JW Pharmaceutical
3
Pitavastatin 4mgPhase 41 trial
pitavastatinPhase 4Small Molecule1 trial
pitavastatinPhase 4Small Molecule2 trials
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without DiabetesN/A1 trial
PitavastatinN/ASmall Molecule1 trial
+1 more programs
Active Trials
NCT07382778Completed1,538Est. Jun 2025
NCT04402112Completed28,343Est. Aug 2017
NCT04270344Unknown905Est. Jun 2022
+4 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
1
2
1
CADUET(atorvastatin)Phase 4Small Molecule5 trials
BococizumabPhase 2Monoclonal Antibody1 trial
PBOPhase 21 trial
PF-04950615Phase 12 trials
Internet-based tailored advice on cardiovascular riskN/A1 trial
Active Trials
NCT00220974Completed3,708Est. Dec 2006
NCT01243151Completed68Est. Oct 2011
NCT00991159Completed48Est. May 2010
+7 more trials
Prevail Therapeutics
2
2
1
Pitavastin 4mgPhase 41 trial
EvacetrapibPhase 31 trial
EvacetrapibPhase 31 trial
LY3015014Phase 21 trial
PPAR alphaPhase 21 trial
Active Trials
NCT01890967Completed527Est. Jun 2014
NCT00133380Completed300Est. Sep 2006
NCT02260648Terminated149Est. Nov 2015
+2 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
3 programs
1
1
1
Lifestyle RegulationPhase 41 trial
CRESTOR(rosuvastatin)Phase 2Small Molecule5 trials
AZD8233Phase 11 trial
Active Trials
NCT03593785Completed73Est. Dec 2020
NCT00160745Completed46Est. Sep 2006
NCT07534592Not Yet Recruiting40Est. Sep 2026
+4 more trials
Chong Kun Dang Pharmaceutical
1
Lipilou®Phase 41 trial
Active Trials
NCT04511000Completed250Est. May 2019
Kowa Pharmaceuticals
Kowa PharmaceuticalsAL - Montgomery
1 program
1
Pitavastin 4mgPhase 4
Medpace
MedpaceCINCINNATI, OH
6 programs
1
3
2
lerodalcibepPhase 31 trial
lerodalcibepPhase 31 trial
ETC-1002Phase 21 trial
ETC-1002Phase 21 trial
ETC-1002Phase 21 trial
+1 more programs
Active Trials
NCT03545438Completed63Est. Jun 2018
NCT02178098Completed143Est. May 2015
NCT01941836Completed349Est. Nov 2014
+3 more trials
LIB Therapeutics
1
1
3
lerodalcibepPhase 31 trial
lerodalcibepPhase 3
lerodalcibepPhase 3
LIB003Phase 21 trial
LIB003Phase 1
Active Trials
NCT03847974Completed32Est. Aug 2020
NCT04790513Completed204Est. Dec 2022
Innovent Biologics
1
1
2
IBI306Phase 31 trial
IBI306 450mg SC Q4WPhase 31 trial
IBI306Phase 21 trial
IBI306Phase 11 trial
Active Trials
NCT03366688Completed58Est. Nov 2018
NCT03815812Completed60Est. Dec 2019
NCT04709536Completed306Est. Jan 2022
+1 more trials
Hasten Pharma
2 programs
1
1
LerodalcibepPhase 31 trial
HST101Phase 11 trial
Active Trials
NCT06504043Enrolling By Invitation30Est. Mar 2025
NCT06568471Recruiting210Est. May 2026
Daewon Pharma
Daewon PharmaKorea - Hwaseong
2 programs
1
1
DW-0929Phase 31 trial
DW-3102Phase 21 trial
Active Trials
NCT02368613Unknown64
NCT02390375Completed348Est. May 2016
Ildong Pharmaceutical
2
RosuvastatinPhase 3Small Molecule1 trial
Rosuvastatin/EzetimibePhase 31 trial
Active Trials
NCT02749994Completed396Est. Feb 2017
NCT02251847Unknown400
Angeles Therapeutics
1
Gamma Delta Tocotrienols - Low DosePhase 31 trial
Active Trials
NCT02634606Terminated13Est. Nov 2015
Ache Laboratorios Farmaceuticos
1
Rosuvastatin + EzetimibePhase 3
CiVi Biopharma
2 programs
1
1
CIVI 007Phase 21 trial
CiVi007Phase 11 trial
Active Trials
NCT03427710Completed36Est. Aug 2020
NCT04164888Completed49Est. Nov 2020
Otsuka
OtsukaJapan - Tokushima
1 program
1
180mg of ETC-1002Phase 21 trial
Active Trials
NCT04784442Completed188Est. May 2022
Cumberland Pharmaceuticals
1
Atorvastatin injectionPhase 21 trial
Active Trials
NCT03611010Completed40Est. Feb 2020
Biocorp
1 program
1
Ezetimibe and placeboPhase 21 trial
Active Trials
NCT00677248Completed120Est. Oct 2008
HighTide Therapeutics
1
HTD1801 Tablets, 500 mgPhase 1/21 trial
Active Trials
NCT03381287Completed50Est. Dec 2018
AFFiRiS
3 programs
3
AFFITOPE AT04APhase 1
AFFITOPE AT06APhase 1
AFFITOPE® AT04A+adjuvantPhase 11 trial
Active Trials
NCT02508896Completed72Est. Aug 2017
Alnylam Pharmaceuticals
1 program
1
ALN-PCSSCPhase 11 trial
Active Trials
NCT02314442Completed70Est. Nov 2015
Arbutus Biopharma
Arbutus BiopharmaPA - Warminster
1 program
1
PRO-040201Phase 11 trial
Active Trials
NCT00927459Terminated23Est. Jan 2010
Vaxxinity
1 program
1
VXX-401Phase 11 trial
Active Trials
NCT05762276Unknown64Est. Jun 2024
Regeneron
RegeneronTARRYTOWN, NY
22 programs
AlirocumabPHASE_1Monoclonal Antibody
AlirocumabPHASE_1Monoclonal Antibody
REGN727PHASE_1
alirocumabPHASE_1Monoclonal Antibody
alirocumab SAR236553PHASE_1
+17 more programs
Active Trials
NCT03175367Completed272Est. Dec 2020
Sanofi
SanofiPARIS, France
9 programs
ALIROCUMAB SAR236553N/A1 trial
alirocumab SAR236553PHASE_11 trial
AVE5530PHASE_21 trial
AlirocumabPHASE_2Monoclonal Antibody5 trials
AlirocumabPHASE_2Monoclonal Antibody1 trial
+4 more programs
Active Trials
NCT03379558Terminated37Est. Sep 2020
NCT01448239Completed24Est. May 2011
NCT00440154Completed206Est. Oct 2007
+12 more trials
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
6 programs
Bempedoic Acid 180Mg/Ezetimibe 10Mg TabN/A1 trial
Colesevelam HydrochloridePHASE_41 trial
colesevelam HClPHASE_41 trial
colesevelam HCl tablets and fenofibrate tabletsPHASE_41 trial
colesevelam HCl tablets, and simvastatin tabletsPHASE_41 trial
+1 more programs
Active Trials
NCT05546398Completed500Est. Nov 2022
NCT00185107Completed45Est. Oct 2005
NCT00145574Completed194Est. Dec 2007
+3 more trials

+19 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
SandozInclisiran sodium
JW PharmaceuticalPitavastatin 4mg
SandozInclisiran Sodium
AstraZenecarosuvastatin
SanofiPraluent
SanofiAlirocumab
Chong Kun Dang PharmaceuticalLipilou®
SanofiAlirocumab
SanofiAlirocumab
SanofiPraluent
SanofiAlirocumab
AstraZenecarosuvastatin
AstraZenecarosuvastatin
AstraZenecarosuvastatin
AstraZenecarosuvastatin

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 20,384 patients across 50 trials

NCT06431763SandozInclisiran sodium

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

Start: Jun 2024Est. completion: Jan 2026402 patients
Phase 4Completed

Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

Start: Aug 2023Est. completion: Nov 202688 patients
Phase 4Active Not Recruiting
NCT05192941SandozInclisiran Sodium

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

Start: Apr 2022Est. completion: Mar 20251,770 patients
Phase 4Completed

Rosuvastatin Effect on Atherosclerotic Plaque Metabolism

Start: Jul 2020Est. completion: Oct 202240 patients
Phase 4Completed

Long Term Safety Study of PRALUENT

Start: Sep 2018Est. completion: Apr 20201,389 patients
Phase 4Terminated

Investigating the Effects of Lipid-therapy Intensification With Alirocumab on Endothelial Function, Carotid Arteries, Lipoprotein Particle Subfractions, Inflammation and Post-prandial Lipemia

Start: Jun 2018Est. completion: Feb 202024 patients
Phase 4Terminated

Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

Start: Oct 2017Est. completion: May 2019250 patients
Phase 4Completed

Alirocumab in Patients With Acute Myocardial Infarction

Start: Jan 2017Est. completion: Aug 201820 patients
Phase 4Completed

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Start: Nov 2016Est. completion: Jul 2018206 patients
Phase 4Completed

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Start: Nov 2016Est. completion: Mar 20202,176 patients
Phase 4Completed

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Start: Mar 2016Est. completion: May 2017413 patients
Phase 4Completed

Effect of Rosuvastatin Therapy on HDL2 Level

Start: Nov 2015Est. completion: Jun 2017300 patients
Phase 4Unknown

Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients(REPAIRS)

Start: Sep 2015Est. completion: Sep 2018456 patients
Phase 4Unknown

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

Start: Apr 2015308 patients
Phase 4Unknown

LDL-C Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day to10 mg/Day in Chinese ACS(Acute Coronary Syndrome) Patients

Start: Mar 2014Est. completion: May 20161,060 patients
Phase 4Unknown
NCT01720719Pfizeratorvastatin

Atorvastatin Versus Vitamin E in Treatment of Non-alcoholic Fatty Liver Disease

Start: May 2013Est. completion: Dec 2016120 patients
Phase 4Unknown
NCT02125682Pfizeratorvastatin

The HDL Particle Protection Study

Start: Jan 2012Est. completion: May 201716 patients
Phase 4Completed

Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve

Start: Dec 2011Est. completion: Oct 201356 patients
Phase 4Completed

A Study Comparing CoQ10 Levels While Taking 3 Different Statins

Start: Dec 2011Est. completion: Oct 2013134 patients
Phase 4Completed
NCT01033058Pfizeratorvastatin

Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI

Start: Dec 2009Est. completion: Jun 2011500 patients
Phase 4Unknown

Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Start: Jun 2009Est. completion: Feb 2011200 patients
Phase 4Completed

Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)

Start: Mar 2009Est. completion: Mar 201260 patients
Phase 4Unknown
NCT01239849Pfizeratorvastatin

Korean AMADEUS Study

Start: Feb 2009Est. completion: Feb 2011500 patients
Phase 4Unknown

Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

Start: Dec 2008Est. completion: Mar 201097 patients
Phase 4Completed
NCT00728988Pfizeratorvastatin

Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

Start: Sep 2008Est. completion: Apr 2010499 patients
Phase 4Completed
NCT00772564Pfizeratorvastatin

The Use of Statins for Myocardial Death Prevention

Start: Aug 2008Est. completion: Aug 201025 patients
Phase 4Completed
NCT00917644Pfizeratorvastatin

Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet

Start: Jul 2008Est. completion: Sep 200876 patients
Phase 4Completed
NCT00917579Pfizeratorvastatin

Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

Start: Jul 2008Est. completion: Sep 200876 patients
Phase 4Completed

A Diabetes Study to Treat A Population Previously Not at Target

Start: May 2008Est. completion: Aug 2009598 patients
Phase 4Completed

Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

Start: Apr 2008Est. completion: Jun 2011187 patients
Phase 4Completed

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Start: Apr 2008Est. completion: Jun 2010140 patients
Phase 4Unknown
NCT00734123Pfizeratorvastatin

Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.

Start: Apr 2008Est. completion: May 20132,948 patients
Phase 4Unknown

Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients

Start: Oct 2007Est. completion: Oct 2008668 patients
Phase 4Completed
NCT01200056Pfizeratorvastatin

Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

Start: Aug 2007Est. completion: Jun 201040 patients
Phase 4Completed
NCT00701220Pfizeratorvastatin

Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Start: Apr 2007Est. completion: Dec 20109 patients
Phase 4Completed
NCT00407537Pfizeratorvastatin

Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors

Start: Mar 2007Est. completion: Oct 20091,531 patients
Phase 4Completed
NCT00441597Pfizeratorvastatin

Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?

Start: Feb 2007Est. completion: Mar 200930 patients
Phase 4Completed
NCT00412113Pfizeratorvastatin

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

Start: Jan 2007Est. completion: Apr 2008245 patients
Phase 4Completed

Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Start: Jan 2007Est. completion: Feb 2009334 patients
Phase 4Completed

Study of Asian Patients With Hypercholesterolaemia in the UK - Rosuvastatin 5mg Versus Atorvastatin 10mg

Start: Dec 2006Est. completion: Feb 200855 patients
Phase 4Terminated

ROMEO (Rosuvastatin in Metabolic syndrOme)

Start: Sep 2006Est. completion: Jun 2008258 patients
Phase 4Completed

Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Start: May 2006Est. completion: Jun 2008192 patients
Phase 4Completed

I PREVENT - Irbesartan In Hypertensive Diabetic Patients

Start: Feb 2006Est. completion: Sep 2008797 patients
Phase 4Completed
NCT00640744Pfizeratorvastatin

Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions

Start: Feb 2006Est. completion: Feb 201012 patients
Phase 4Unknown
NCT00652327MSDEzetimibe + Statin

Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)

Start: Dec 2005Est. completion: Jul 200783 patients
Phase 4Completed

Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

Start: Nov 2005Est. completion: Dec 2007194 patients
Phase 4Completed

Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Start: Nov 2005Est. completion: Feb 2007400 patients
Phase 4Completed

Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

Start: Oct 2005Est. completion: Oct 2008214 patients
Phase 4Completed

C-Reactive Protein (CRP) in Obese Diabetic Women

Start: Oct 2005100 patients
Phase 4Completed

Irbesartan in Hypertension

Start: Sep 200588 patients
Phase 4Completed

Related Jobs

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

47 late-stage (Phase 3) programs, potential near-term approvals
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.