Hypercholesterolemia

71
Pipeline Programs
17
Companies
50
Clinical Trials
8
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
16
0
14
0
22
19
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1761%
Small Molecule
1036%
RNA Therapeutic
14%
+ 45 programs with unclassified modality

On Market (8)

Approved therapies currently available

AstraZeneca
CRESTORApproved
rosuvastatin
AstraZeneca
oral2003
U
IRBESARTANApproved
irbesartan
Unknown Company
Angiotensin 2 Receptor Blocker [EPC]oral2018
U
KYNAMROApproved
mipomersen sodium
Unknown Company
subcutaneous2013
U
NIACINApproved
niacin
Unknown Company
oral
U
NIACORApproved
niacin
Unknown Company
Nicotinic Acid [EPC]oral2000
Regeneron
PRALUENTApproved
alirocumab
Regeneron
PCSK9 Inhibitor [EPC]injection2015
Amgen
REPATHAApproved
evolocumab
Amgen
PCSK9 Inhibitor [EPC]injection2015
U
WELCHOLApproved
colesevelam hydrochloride
Unknown Company
oral2000

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
22 programs
8
5
7
2
Alirocumab SAR236553Phase 4
PraluentPhase 4
ALIROCUMAB SAR236553Phase 3
AlirocumabPhase 3Monoclonal Antibody
AlirocumabPhase 3Monoclonal Antibody
+17 more programs
Active Trials
NCT03175367Completed272Est. Dec 2020
Sanofi
SanofiPARIS, France
9 programs
1
3
3
1
PraluentPhase 42 trials
AlirocumabPhase 3Monoclonal Antibody1 trial
Alirocumab SAR236553Phase 31 trial
AtorvastatinPhase 3Small Molecule1 trial
AVE5530Phase 25 trials
+4 more programs
Active Trials
NCT03379558Terminated37Est. Sep 2020
NCT01448239Completed24Est. May 2011
NCT00766688Terminated643Est. Jun 2009
+15 more trials
DS
Daiichi SankyoChina - Shanghai
6 programs
5
Colesevelam HydrochloridePhase 41 trial
colesevelam HClPhase 41 trial
colesevelam HCl tablets and fenofibrate tabletsPhase 41 trial
colesevelam HCl tablets, and simvastatin tabletsPhase 41 trial
pravastatin tablets and Welchol tabletsPhase 41 trial
+1 more programs
Active Trials
NCT05546398Completed500Est. Nov 2022
NCT00185107Completed45Est. Oct 2005
NCT00145574Completed194Est. Dec 2007
+3 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
4 programs
3
1
Lifestyle RegulationPhase 41 trial
ABT-335 and rosuvastatin calciumPhase 31 trial
RosuvastatinPhase 3Small Molecule1 trial
RosuvastatinPhase 3Small Molecule5 trials
Active Trials
NCT00463606Completed760Est. Feb 2008
NCT00525824Completed1,743Est. Sep 2008
NCT00160745Completed46Est. Sep 2006
+5 more trials
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
2
1
EvolocumabPhase 3Monoclonal Antibody1 trial
EvolocumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT02739984Completed424Est. Aug 2017
NCT01813422Completed970Est. Jul 2016
Bristol Myers Squibb
2 programs
1
1
PravastatinPhase 4Small Molecule1 trial
IrbesartanPhase 3Small Molecule3 trials
Active Trials
NCT00152698Withdrawn0Est. Dec 2009
NCT00125645Completed200Est. Sep 2011
NCT00347087Completed36Est. Jun 2007
+1 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
Pitavastin 4mgPhase 41 trial
Active Trials
NCT01660191Completed134Est. Oct 2013
M&
Merck & Co.RAHWAY, NJ
8 programs
3
1
3
ezetimibe with simvastatinPhase 3Small Molecule1 trial
ezetimibe with simvastatinPhase 3Small Molecule1 trial
niacinPhase 31 trial
MK0859Phase 21 trial
MK-0616Phase 11 trial
+3 more programs
Active Trials
NCT00908011Completed43Est. Jan 2015
NCT06592339Completed24Est. Dec 2022
NCT00565292Completed50Est. Aug 2006
+5 more trials
Ionis Pharmaceuticals
4 programs
2
2
MipomersenPhase 3RNA Therapeutic1 trial
Mipomersen sodiumPhase 31 trial
ISIS 301012 or PlaceboPhase 21 trial
ISIS 301012 or PlaceboPhase 21 trial
Active Trials
NCT00216463Completed50Est. Aug 2007
NCT00231569Completed74Est. Dec 2007
NCT00794664Completed58Est. Oct 2010
+1 more trials
Takeda
TakedaTOKYO, Japan
2 programs
1
1
Lapaquistat acetatePhase 35 trials
Lapaquistat acetate and atorvastatinPhase 2Small Molecule3 trials
Active Trials
NCT00143676Completed448Est. Aug 2006
NCT00487994Completed2,130Est. May 2007
NCT00864643Completed172Est. Feb 2005
+5 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
3
1
PBOPhase 21 trial
PF-04950615Phase 11 trial
PF-04950615Phase 11 trial
PF-06815345Phase 11 trial
Internet-based tailored advice on cardiovascular riskN/A1 trial
Active Trials
NCT00220974Completed3,708Est. Dec 2006
NCT01243151Completed68Est. Oct 2011
NCT01435382Completed49Est. Apr 2012
+2 more trials
Ironwood Pharmaceuticals
1 program
1
MD-0727Phase 21 trial
Active Trials
NCT00404001CompletedEst. Jul 2007
Alnylam Pharmaceuticals
1 program
1
ALN-PCSSCPhase 11 trial
Active Trials
NCT02314442Completed70Est. Nov 2015
Pulse Biosciences
Pulse BiosciencesCA - Hayward
2 programs
BeansN/A1 trial
Canned beans of multiple varietiesN/A1 trial
Active Trials
NCT01661543CompletedEst. Dec 2015
NCT03830970CompletedEst. Jan 2021
Bayer
BayerLEVERKUSEN, Germany
2 programs
EzetimibeN/A1 trial
EzetimibeN/A1 trial
Active Trials
NCT00705211Completed1,794Est. Dec 2009
NCT00704444Completed11,332Est. Sep 2009
Verona Pharma
Verona PharmaUK - London
1 program
LDL-apheresisN/A1 trial
Active Trials
NCT01678521Completed12Est. Dec 2013
Astellas
AstellasChina - Shenyang
1 program
atrovastatinN/ASmall Molecule1 trial
Active Trials
NCT01446679Completed24,050Est. Mar 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstraZenecaRosuvastatin
SanofiPraluent
SanofiAlirocumab
SanofiAlirocumab
SanofiAlirocumab
SanofiPraluent
SanofiAlirocumab
AstraZenecaRosuvastatin
AstraZenecaRosuvastatin
AstraZenecaRosuvastatin
Eli Lilly and CompanyPitavastin 4mg
AstraZenecaRosuvastatin
AstraZenecaRosuvastatin
AstraZenecaRosuvastatin
AstraZenecaRosuvastatin

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 16,210 patients across 50 trials

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

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

Start: Sep 2015Est. completion: Sep 2018456 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

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

Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)

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

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

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

A Diabetes Study to Treat A Population Previously Not at Target

Start: May 2008Est. completion: Aug 2009598 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

Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

Start: Apr 2008Est. completion: Mar 2013250 patients
Phase 4Terminated

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

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

Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

Start: Jun 2006Est. completion: Dec 200972 patients
Phase 4Completed

Comparison of Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

Start: Apr 2006Est. completion: Sep 200718 patients
Phase 4Completed

Effects of Rosuvastatin on the, in Vivo, Kinetic of apoB and apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

Start: Jan 2006Est. completion: Sep 20078 patients
Phase 4Completed

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

Start: Nov 2005Est. completion: Dec 2007194 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

Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

Start: Aug 2005Est. completion: Jan 2007370 patients
Phase 4Completed
NCT00185107Daiichi SankyoColesevelam Hydrochloride

Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Start: Mar 2005Est. completion: Oct 200545 patients
Phase 4Completed

Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

Start: Mar 2005Est. completion: Sep 2011200 patients
Phase 4Completed

Effect of Crestor on Lipoprotein Metabolism in Humans

Start: Jan 2005Est. completion: Feb 20068 patients
Phase 4Completed

Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

Start: Jul 2004Est. completion: Jun 200736 patients
Phase 4Completed
NCT00754039Daiichi Sankyocolesevelam HCl tablets and fenofibrate tablets

Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

Start: Feb 2003Est. completion: Mar 2004129 patients
Phase 4Completed
NCT00240357AstraZenecaLifestyle Regulation

Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia

Start: Feb 20031,175 patients
Phase 4Withdrawn

Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

Start: Dec 2002Est. completion: Mar 2005232 patients
Phase 4Completed
NCT00753779Daiichi Sankyocolesevelam HCl tablets, and simvastatin tablets

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

Start: Nov 2002Est. completion: Apr 200572 patients
Phase 4Completed
NCT00755352Daiichi Sankyopravastatin tablets and Welchol tablets

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.

Start: Nov 2002Est. completion: Apr 200567 patients
Phase 4Completed

ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

Start: Feb 20021,294 patients
Phase 4Withdrawn
NCT03510715SanofiAlirocumab SAR236553

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start: Aug 2018Est. completion: Feb 202018 patients
Phase 3Completed

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Start: May 2018Est. completion: Aug 2022153 patients
Phase 3Completed

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Start: Mar 2018Est. completion: Aug 201869 patients
Phase 3Completed

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Start: Oct 2017Est. completion: Feb 202069 patients
Phase 3Completed

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

Start: Jul 2016Est. completion: Aug 2018615 patients
Phase 3Completed

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Start: May 2016Est. completion: Aug 2017424 patients
Phase 3Completed

Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Start: Nov 2015Est. completion: Jan 2018163 patients
Phase 3Completed

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Start: Oct 2015Est. completion: Apr 2017517 patients
Phase 3Completed

A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis

Start: Sep 2015Est. completion: Jan 2019543 patients
Phase 3Completed

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Start: Jun 2015Est. completion: Apr 2019998 patients
Phase 3Completed

A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start: Jun 2015Est. completion: Nov 20169 patients
Phase 3Completed

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

Start: Mar 2015Est. completion: Apr 201662 patients
Phase 3Completed

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start: Nov 2014Est. completion: Jul 201520 patients
Phase 3Completed

Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

Start: Mar 2014Est. completion: Sep 2015216 patients
Phase 3Completed

Phase Legend

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

Key Insights

22 late-stage (Phase 3) programs — potential near-term approvals
17 companies competing in this space