Clinical Trials

Ezetimibe has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, alongside early phase studies, assessing its safety and low-density lipoprotein cholesterol-lowering efficacy as monotherapy or combined with statins and other lipid-lowering agents. These investigations focus on cardiovascular and metabolic disorders, including hypercholesterolemia, atherosclerosis, coronary artery disease, acute coronary syndrome, type 2 diabetes mellitus, and chronic kidney disease. Sponsored by pharmaceutical companies like Sanofi and Organon, alongside academic institutions including Korea University and Xijing Hospital, these trials encompass completed, active, recruiting, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06722521 RECRUITING
Primary Prevention; Vascular Calcification
Asan Medical Center
2025-07-09 PHASE4
NCT07524101 RECRUITING
Renal Insufficiency; Atherosclerosis; Dyslipidemia; Hypercholesterolemia; Cardiovascular Diseases
Yonsei University
2026-05-28
NCT05579626 ENROLLING_BY_INVITATION
Pre Diabetes; ASCVD
Seung-Whan Lee, M.D., Ph.D.
2023-03-14 PHASE4
NCT06649240 RECRUITING
Ischemic Stroke; Small Vessel Cerebrovascular Disease; Cholesterol, LDL; Secondary Prevention; Cardiovascular Diseases
Seoul National University Hospital
2024-10-04
NCT07359105 RECRUITING
Dyslipidemia Associated With Type II Diabetes Mellitus
Sin Gon Kim
2026-03-09
NCT07799779 NOT_YET_RECRUITING
Acute Coronary Syndromes (ACS)
Seoul National University Bundang Hospital
2026-09 PHASE4
NCT06767774 RECRUITING
ASCVD; Diabetes; Statin
Korea University Anam Hospital
2025-04-25 PHASE4
NCT07307989 RECRUITING
Ischemic Stroke; Hypercholesteremia
Chang Gung Memorial Hospital
2025-08-01 PHASE2
NCT05845424 RECRUITING
Coronary Artery Calcification; Metabolic Syndrome; Dyslipidemias
Samsung Medical Center
2023-07-03 PHASE4
NCT06186037 RECRUITING
Coronary Artery Disease; Dyslipidemias; Primary Prevention
Saint Vincent's Hospital, Korea
2024-02-01 PHASE4
NCT07605130 NOT_YET_RECRUITING
Intracranial Arteriosclerosis; Cognitive Impairment
Peking Union Medical College Hospital
2026-05-25 PHASE4
NCT07626840 NOT_YET_RECRUITING
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Samsung Medical Center
2026-06-01
NCT07752758 NOT_YET_RECRUITING
Atrial Fibrillation; Post-Catheter Ablation Atrial Arrhythmia Recurrence
Second Affiliated Hospital, Zhejiang University, School of Medicine
2026-08-15 PHASE4
NCT07474649 NOT_YET_RECRUITING
Coronary Atherosclerosis; Mixed Dyslipidemia; Hypercholesterolemia
Daiichi Sankyo
2026-08-15 PHASE3
NCT07219602 RECRUITING
Lipidemia; Type 2 Diabetes (T2DM); Metabolic Syndrome (MetS)
NewAmsterdam Pharma
2025-12-11 PHASE3
NCT06437574 RECRUITING
Prostate Cancer
Cedars-Sinai Medical Center
2024-07-16 PHASE2
NCT06767345 RECRUITING
Coronary Artery Disease; Atherosclerosis of Coronary Artery; Plaque, Atherosclerotic
Korea University Anam Hospital
2025-05-12 PHASE4
NCT04968509 RECRUITING
Aortic Stenosis
Beijing Anzhen Hospital
2024-03-22 PHASE3
NCT05782777 RECRUITING
Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
Yonsei University
2023-04-07
NCT07704918 RECRUITING
Melanoma
University of Colorado, Denver
2026-12-31
NCT06305559 ACTIVE_NOT_RECRUITING
Lipidemia; Coronary Artery Disease; Plaque, Atherosclerotic
NewAmsterdam Pharma
2024-05-16 PHASE3
NCT05641753 RECRUITING
Type 1 Diabetes
NYU Langone Health
2022-12-06 PHASE4
NCT05705804 RECRUITING
Dyslipidemias; Atherosclerotic Cardiovascular Disease
Yonsei University
2023-06-13
NCT06293417 RECRUITING
T2DM (Type 2 Diabetes Mellitus); Dyslipidemias
Korea University Anam Hospital
2024-03-01
NCT03169985 ACTIVE_NOT_RECRUITING
Coronary Artery Disease
Samsung Medical Center
2017-07-12 PHASE4
NCT05365438 RECRUITING
Dyslipidemias; Atherosclerosis; Diabetes Mellitus, Type 2
Seoul National University Bundang Hospital
2022-10-01 PHASE4
NCT06854523 NOT_YET_RECRUITING
Acute Myocardial Infarction
Yun Dai Chen
2025-04-15
NCT07508254 NOT_YET_RECRUITING
Acute Coronary Syndromes (ACS); Hypercholesterolemia
Punjab Institute of Cardology
2026-05-01 PHASE4
NCT05910476 ACTIVE_NOT_RECRUITING
Coronary Artery Disease; Dyslipidemias
Yonsei University
2023-05-03 PHASE4
NCT07622433 ACTIVE_NOT_RECRUITING
Healthy Participants
AstraZeneca
2026-06-10 PHASE1
NCT04499859 RECRUITING
Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity
Kiyuk Chang, MD,PhD
2020-10-01 PHASE4
NCT06317051 ACTIVE_NOT_RECRUITING
HIV Infections; Weight Gain
Kirby Institute
2024-12-16 PHASE3
NCT06231966 RECRUITING
Peripheral Artery Disease; Polyvascular Disease
Yonsei University
2024-04-22
NCT05587621 NOT_YET_RECRUITING
ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; LDL-cholesterol
Jena University Hospital
2024-04-01
NCT07255820 COMPLETED
Type 2 Diabetes Mellitus; Hypercholesterolemia / Elevated LDL Cholesterol
Bahria University
2026-01-01 PHASE4
NCT07268625 COMPLETED
Healthy Subjects
Daiichi Sankyo
2025-12-09 PHASE1
NCT07235189 COMPLETED
Healthy Subjects
Daiichi Sankyo
2025-10-28 PHASE1
NCT07442630 ACTIVE_NOT_RECRUITING
Hypercholesterolemia
JW Pharmaceutical
2023-08-21 PHASE4
NCT07201545 COMPLETED
Healthy Subjects
Daiichi Sankyo
2025-10-07 PHASE1
NCT04701242 UNKNOWN
Acute Myocardial Infarction; Dyslipidemias
Cairo University
2021-03-24
NCT07182383 COMPLETED
Healthy Subjects
Daiichi Sankyo
2025-09-29 PHASE1
NCT04508907 ACTIVE_NOT_RECRUITING
Hepatitis C; Kidney Transplant; Complications; Heart Transplant Infection
Mayo Clinic
2020-09-10 PHASE4
NCT06742853 COMPLETED
Dyslipidemia
AstraZeneca
2024-12-20 PHASE1
NCT06789432 RECRUITING
Hyperlipidemia (E.G., Hypercholesterolemia)
Dr. Md. Alimur Reza
2025-02-01 PHASE4
NCT04626973 COMPLETED
Atherosclerotic Cardiovascular Disease
Yonsei University
2021-01-15
NCT06784557 RECRUITING
Atherosclerotic Cardiovascular Disease With Dyslipidemia
Yonsei University
2024-02-28 PHASE4
NCT06381947 UNKNOWN
Dyslipidemias; Statin Adverse Reaction; Cardiovascular Diseases; Lipid Metabolism Disorders
University of Salerno
2024-05-01 PHASE4
NCT06646354 ENROLLING_BY_INVITATION
Hypertension; Primary Hypercholesterolaemia
Hyundai Pharm
2025-04-22 PHASE3
NCT06450366 COMPLETED
Hypercholesterolemia
Merck Sharp & Dohme LLC
2024-07-08 PHASE3
NCT05661552 COMPLETED
Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Yonsei University
2022-12-01 PHASE4
NCT04862260 ACTIVE_NOT_RECRUITING
Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreas Cancer; Metastatic Cancer
CHU de Quebec-Universite Laval
2021-10-04 EARLY_PHASE1
NCT05613400 UNKNOWN
Diabetes Mellitus, Type 2
The University of Hong Kong
2022-04-13 PHASE4
NCT06547359 COMPLETED
Healthy Volunteers
NewAmsterdam Pharma
2024-10-01 PHASE1
NCT04900155 UNKNOWN
STEMI; Covid19; NSTEMI
Penza State University
2020-11-20
NCT06005597 COMPLETED
Dyslipidemias; Hypercholesterolemia; Familial Hypercholesterolemia; ASCVD; High Cholesterol
NewAmsterdam Pharma
2024-03-01 PHASE3
NCT05930028 COMPLETED
Essential Hypertension; Primary Hypercholesterolemia
Boryung Pharmaceutical Co., Ltd
2023-07-13 PHASE3
NCT05761444 COMPLETED
Atherosclerotic Cardiovascular Disease
Organon and Co
2023-07-26 PHASE4
NCT06578676 UNKNOWN
Type 2 Diabetes; Dyslipidemias
Hyundai Pharm
2024-06-20 PHASE1
NCT05763875 COMPLETED
Hypercholesterolemia
Novartis Pharmaceuticals
2023-03-15 PHASE3
NCT05368545 COMPLETED
Coronary Artery Disease
Aarhus University Hospital
2020-05-15
NCT06050291 COMPLETED
Healthy Volunteer Study
NewAmsterdam Pharma
2024-01-20 PHASE1
NCT06021951 COMPLETED
Healthy Lactating Women
Esperion Therapeutics, Inc.
2023-08-04 PHASE4
NCT05795517 COMPLETED
Hypercholesterolemia
Haisco Pharmaceutical Group Co., Ltd.
2023-04-26 PHASE2
NCT07564726 COMPLETED
Hypertension; Hypercholesterolemia
Celltrion Pharm, Inc.
2022-08-05 PHASE3
NCT05884502 UNKNOWN
Dyslipidemias; Stroke, Acute Ischemic
Korea University Anam Hospital
2022-09-01 PHASE4
NCT04369664 COMPLETED
Type 2 Diabetes
NYU Langone Health
2020-08-12 PHASE4
NCT05263778 UNKNOWN
Cardiovascular Diseases; NSTEMI; STEMI
Kaiser Permanente
2022-03 PHASE4
NCT04433533 UNKNOWN
Left Ventricular Diastolic Dysfunction; Hyperlipidemias
Yonsei University
2021-01-06 PHASE4
NCT04826354 COMPLETED
Atheroscleroses, Coronary
Korea University Anam Hospital
2021-08-11 PHASE4
NCT05970679 COMPLETED
Hypercholesterolemia, Dyslipidemia
Daewon Pharmaceutical Co., Ltd.
2022-08-17 PHASE3
NCT04173403 COMPLETED
Hypercholesterolemia
Akeso
2019-11-04 PHASE2
NCT04173793 COMPLETED
Heterozygous Familial Hypercholesterolemia
Akeso
2019-11-18 PHASE2
NCT05381870 UNKNOWN
Pharmacokinetics; Safety
The Affiliated Hospital of Qingdao University
2022-05-26 PHASE1
NCT05481385 UNKNOWN
Pharmacokinetics; Safety
The Affiliated Hospital of Qingdao University
2022-07-15 PHASE1
NCT05266586 COMPLETED
Dyslipidemias; High Cholesterol; Hypercholesterolemia
NewAmsterdam Pharma
2022-03-09 PHASE2
NCT04669041 COMPLETED
Hypercholesterolemia
Sanofi
2020-12-08 PHASE3
NCT04659070 UNKNOWN
Primary Hypercholesterolemia; Hypertension
Hanlim Pharm. Co., Ltd.
2020-07-15 PHASE3
NCT04589351 UNKNOWN
Diabetes Mellitus, Type 2; Diabetic Kidney Disease
Steno Diabetes Center Copenhagen
2020-10-01 PHASE3
NCT03044665 UNKNOWN
Cardiovascular Diseases; Cerebrovascular Disease; Peripheral Atherosclerotic Disease
Yonsei University
2017-03-15
NCT04659525 UNKNOWN
Hypercholesterolemia; CKD Stage 5; Chronic Kidney Disease Requiring Chronic Dialysis
Policlinico Casilino ASL RMB
2020-11-01 PHASE4
NCT04161001 UNKNOWN
Hypertension, Dyslipidemia
Daewoong Pharmaceutical Co. LTD.
2019-11-20 PHASE3
NCT03403556 UNKNOWN
Atherosclerotic Cardiovascular Disease; Type 2 Diabetes
Yuhan Corporation
2018-03-27 PHASE4
NCT03993236 COMPLETED
Stroke, Ischemic
Keun-Sik Hong
2019-09-09 PHASE4
NCT04643093 COMPLETED
Primary Hypercholesterolemia; Mixed Dyslipidemias
Orient Pharma Co., Ltd.
2020-08-01 PHASE3
NCT04638400 TERMINATED
Inflammation; Atherosclerosis; Hypercholesterolemia
paresh Dandona
2017-05-01 PHASE4
NCT04814589 UNKNOWN
Therapeutic Equivalency
Cao Yu
2021-03-13 PHASE1
NCT04700436 COMPLETED
Endocrine System Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Dyslipidemias
Seoul National University Hospital
2020-01-03 PHASE4
NCT04770389 COMPLETED
Dyslipidemias; High Cholesterol; Hypercholesterolemia
NewAmsterdam Pharma
2021-02-23 PHASE2
NCT02971033 TERMINATED
Chronic Hepatitis C
VA Office of Research and Development
2018-04-16 PHASE2
NCT03768427 COMPLETED
Hypercholesterolemia
Organon and Co
2019-05-27 PHASE3
NCT03933293 COMPLETED
Homozygous Familial Hypercholesterolemia
Akeso
2019-05-13 PHASE2
NCT04358432 COMPLETED
Hypercholesterolemia
Akeso
2020-05-13 PHASE2
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
2018-05-31 PHASE3
NCT04158076 COMPLETED
Hypercholesterolemia; Hypertension
Addpharma Inc.
2020-01-23 PHASE3
NCT04017338 UNKNOWN
Lung Transplant Infection; Heart Transplant Infection; Kidney Transplant Infection; Kidney Pancreas Infection; Hepatitis C
Jordan Feld
2018-08-06 PHASE3
NCT03847506 COMPLETED
Hypertension, Hyperlipidemia
HK inno.N Corporation
2018-07-05 PHASE4
NCT03750760 WITHDRAWN
Myocardial Infarction; Dyslipidemias
Imperial College London
2020-01 PHASE4
NCT04397653 UNKNOWN
Hypercholesterolemia; Chronic Kidney Disease Requiring Chronic Dialysis
Policlinico Casilino ASL RMB
2020-05-04 PHASE4
NCT03872232 COMPLETED
Hypercholesterolemia; Hypertension
Addpharma Inc.
2019-02-26 PHASE3
NCT03597412 COMPLETED
Atherosclerotic Cardiovascular Disease; Type 2 Diabetes Mellitus
Yuhan Corporation
2018-10-17 PHASE4
NCT04584736 COMPLETED
Primary Hypercholesterolemia
JW Pharmaceutical
2019-06-11 PHASE3
NCT04074551 COMPLETED
Hypertension; Dyslipidemias
Hanmi Pharmaceutical Company Limited
2019-07-16 PHASE3
NCT03543774 UNKNOWN
Hypercholesterolemia; Chronic Kidney Diseases
Hue University of Medicine and Pharmacy
2018-06-15 PHASE4
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
2018-08-31 PHASE3
NCT04844996 COMPLETED
Endometriosis
Mersin University
2019-09-01 EARLY_PHASE1
NCT00679237 COMPLETED
Coronary Heart Disease
Sorlandet Hospital HF
2007-09
NCT03355027 UNKNOWN
Atherosclerosis; Cardiovascular Diseases
Cambridge University Hospitals NHS Foundation Trust
2017-11-30
NCT03494270 COMPLETED
ASCVD
Yuhan Corporation
2018-03-18 PHASE4
NCT03434613 COMPLETED
Nonalcoholic Fatty Liver Disease; Dyslipidemias
Yonsei University
2018-05-14 PHASE4
NCT04056169 COMPLETED
Acute Coronary Syndrome; Carotid Atherosclerotic Plaque With Inflammation
Yuhan Corporation
2017-06-29 PHASE4
NCT03531905 COMPLETED
Diabetes; Diabetes Mellitus, Type 2; Cholesterolemia
Esperion Therapeutics, Inc.
2018-05-09 PHASE2
NCT04080310 COMPLETED
Cardiovascular Diseases
Seoul National University Bundang Hospital
2018-03-15 PHASE4
NCT02476006 COMPLETED
Hypercholesterolemia
Sanofi
2015-06-23 PHASE3
NCT03217409 COMPLETED
Diabetes Mellitus and Hypercholesterolemia
Yuhan Corporation
2017-08-10 PHASE4
NCT03771053 UNKNOWN
Coronary Heart Disease
Chinese PLA General Hospital
2018-01-01
NCT03446261 COMPLETED
Type 2 Diabetes Mellitus; Hypercholesterolemia
Yuhan Corporation
2018-02-23 PHASE4
NCT02534376 COMPLETED
Prostate Cancer
Cedars-Sinai Medical Center
2015-09 EARLY_PHASE1
NCT02772640 COMPLETED
Hypercholesterolemia
Collegium Medicum w Bydgoszczy
2016-03 PHASE4
NCT02890992 COMPLETED
Hypercholesterolaemia
Sanofi
2016-09-15 PHASE2
NCT03532854 COMPLETED
Healthy Male Volunteers
LG Chem
2018-05-28 PHASE1
NCT02715726 COMPLETED
Hypercholesterolemia
Sanofi
2016-07-27 PHASE3
NCT02984982 COMPLETED
Hypercholesterolemia; Acute Coronary Syndrome
Sanofi
2016-11-15 PHASE4
NCT03337308 COMPLETED
Hyperlipidemias
Esperion Therapeutics, Inc.
2017-10-23 PHASE3
NCT05681247 COMPLETED
Hyperlipidemias
The Affiliated Hospital of Qingdao University
2017-12-17 PHASE1
NCT04895059 COMPLETED
Healthy
Laboratorios Silanes S.A. de C.V.
2017-04-30 PHASE1
NCT03001076 COMPLETED
Hypercholesterolemia; Atherosclerosis; Statin Adverse Reaction
Esperion Therapeutics, Inc.
2016-11-29 PHASE3
NCT03277079 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
2017-10-01 PHASE4
NCT02748057 COMPLETED
Hypercholesterolemia; Familial Hypercholesterolemia
Organon and Co
2016-05-18 PHASE3
NCT02588235 UNKNOWN
Coronary Artery Disease
Xijing Hospital
2015-10 PHASE4
NCT02634580 COMPLETED
Hypercholesterolemia
Amgen
2016-02-27 PHASE3
NCT03051100 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
2017-01-19 PHASE2
NCT03099278 UNKNOWN
Chronic Hepatitis D
Ziauddin Hospital
2017-01 PHASE2
NCT02682680 COMPLETED
Type 2 Diabetes Mellitus
LMC Diabetes & Endocrinology Ltd.
2016-01-11 PHASE4
NCT02642159 COMPLETED
Dyslipidemia
Sanofi
2016-03-15 PHASE4
NCT02749994 COMPLETED
Hypercholesterolemia
IlDong Pharmaceutical Co Ltd
2016-04 PHASE3
NCT02741245 COMPLETED
Hypercholesterolemia
Organon and Co
2016-06-09 PHASE3
NCT02460159 COMPLETED
Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
Organon and Co
2015-06-23 PHASE3
NCT03105310 UNKNOWN
Hepatitis D, Chronic
Aga Khan University
2016-01 PHASE2
NCT02548936 UNKNOWN
Atherosclerosis
Peking Union Medical College Hospital
2015-04 EARLY_PHASE1
NCT02550288 COMPLETED
Hypercholesterolemia
Organon and Co
2015-09-29 PHASE3
NCT02942602 COMPLETED
Hyperlipidemia
Yonsei University
2014-04-03
NCT02768545 UNKNOWN
Hepatitis C
Pontificia Universidad Catolica de Chile
2013-06 PHASE4
NCT02547402 COMPLETED
Acute Kidney Injury
Complexa, Inc.
2015-12 PHASE1
NCT02126137 UNKNOWN
Chronic Hepatitis C
Pontificia Universidad Catolica de Chile
2013-10 PHASE1
NCT01807078 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
2014-01 PHASE4
NCT02227784 TERMINATED
Hyperlipidemia
Eli Lilly and Company
2014-10 PHASE3
NCT02501200 COMPLETED
Healthy
Chong Kun Dang Pharmaceutical
2015-08 PHASE1
NCT03288038 COMPLETED
Hypercholesterolemia
Shin Poong Pharmaceutical Co. Ltd.
2014-10-13 PHASE3
NCT01984424 COMPLETED
Hyperlipidemia
Amgen
2013-12-10 PHASE3
NCT02103049 COMPLETED
Dyslipidemia; Transplants
University Medical Centre Ljubljana
2014-04 PHASE4
NCT02260648 TERMINATED
Hypercholesterolemia
Eli Lilly and Company
2015-01 PHASE3
NCT02461004 COMPLETED
Healthy
Chong Kun Dang Pharmaceutical
2015-07 PHASE1
NCT02451098 COMPLETED
Hyperlipidemia
Chong Kun Dang Pharmaceutical
2015-03 PHASE3
NCT01068093 UNKNOWN
Coronary Artery Disease
Yokohama City University Medical Center
2010-10 PHASE4
NCT02244944 TERMINATED
Nonalcoholic Fatty Liver Disease (NAFLD)
Gregory Graf, PhD
2014-09 PHASE2
NCT03571087 COMPLETED
Primary Hypercholesterolemia
Hanlim Pharm. Co., Ltd.
2014-09 PHASE3
NCT02251847 UNKNOWN
Hypercholesterolemia
IlDong Pharmaceutical Co Ltd
2014-07 PHASE3
NCT01603758 COMPLETED
Coronary Heart Disease; Cardiovascular Disease; Dyslipidemia; Disorder of Cholesterol Metabolism
Richard E. Ostlund Jr., MD
2014-01 PHASE1
NCT01849068 COMPLETED
Metabolic Syndrome X
Laval University
2013-06 PHASE3
NCT02234544 COMPLETED
Vitamin D Deficiency
Federal University of Rio Grande do Sul
2014-10 PHASE4
NCT02288338 COMPLETED
Healthy
Chong Kun Dang Pharmaceutical
2014-11 PHASE1
NCT02289430 COMPLETED
Healthy
NVP Healthcare
2014-12 PHASE1
NCT02730689 COMPLETED
Healthy Volunteers
Alvogen Korea
2014-12 PHASE1
NCT02445352 COMPLETED
Primary Hypercholesterolemia
Alvogen Korea
2014-07 PHASE3
NCT02055976 COMPLETED
Hypercholesterolemia
Pfizer
2014-03 PHASE2
NCT01520077 COMPLETED
Alopecia Areata
University of Miami
2011-07 PHASE1
NCT00908011 COMPLETED
Hypercholesterolemia; HIV Infections
University of British Columbia
2009-06
NCT01490229 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
2013-01 PHASE4
NCT01420549 COMPLETED
Hypercholesterolemia; Dyslipidemia
Ache Laboratorios Farmaceuticos S.A.
2013-03 PHASE3
NCT01941836 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
2013-09 PHASE2
NCT01950884 UNKNOWN
•Non-alcoholic Steatohepatitis (NASH)
University of Palermo
2013-10 PHASE4
NCT00202878 COMPLETED
Hypercholesterolemia; Myocardial Infarction
Organon and Co
2005-10-17 PHASE3
NCT02127320 COMPLETED
Healthy
Hanmi Pharmaceutical Company Limited
2014-06 PHASE1
NCT01766713 COMPLETED
Non Alcoholic Steatohepatitis
University of California, San Diego
2013-01 PHASE2
NCT01385631 COMPLETED
ST-Segment Elevation Myocardial Infarction
Odense University Hospital
2011-06 PHASE4
NCT01709513 COMPLETED
Hypercholesterolemia
Regeneron Pharmaceuticals
2012-09-30 PHASE3
NCT01587235 WITHDRAWN
Dyslipidemia
Organon and Co
2013-03 PHASE4
NCT01644188 COMPLETED
Hypercholesterolemia
Sanofi
2012-08 PHASE3
NCT01730053 COMPLETED
Hypercholesterolemia
Regeneron Pharmaceuticals
2012-11-30 PHASE3
NCT01890967 COMPLETED
Hypercholesterolemia
Eli Lilly and Company
2013-06 PHASE2
NCT01730040 COMPLETED
Hypercholesterolemia
Regeneron Pharmaceuticals
2012-10 PHASE3
NCT01043380 COMPLETED
Hypercholesterolemia; Coronary Artery Disease
Kumamoto University
2010-01 PHASE4
NCT02029625 COMPLETED
Dyslipidemia
NVP Healthcare
2014-02 PHASE1
NCT01611883 COMPLETED
Hypercholesterolemia
Organon and Co
2012-07-02 PHASE4
NCT02129231 COMPLETED
Oxidative Stress; Diabetic Polyneuropathy
University of Guadalajara
2012-02 PHASE2
NCT01763905 COMPLETED
Hyperlipidemia
Amgen
2013-01-24 PHASE3
NCT01763866 COMPLETED
Hyperlipidemia
Amgen
2013-01-15 PHASE3
NCT01857843 COMPLETED
Acute Coronary Syndrome
Yonsei University
2009-11 PHASE4
NCT01516879 COMPLETED
Hypercholesterolemia
Amgen
2012-01-05 PHASE3
NCT01763827 COMPLETED
Hyperlipidemia
Amgen
2013-01-21 PHASE3
NCT01584206 COMPLETED
Sitosterolemia
University of Manitoba
2012-04
NCT01644474 COMPLETED
Hypercholesterolemia
Sanofi
2012-07 PHASE3
NCT00879710 COMPLETED
Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Hypercholesterolemia
Medical College of Wisconsin
2008-08
NCT01723735 COMPLETED
Hypercholesterolemia
Sanofi
2012-11 PHASE1
NCT00461630 COMPLETED
Cardiovascular Disease; Peripheral Arterial Disease; Diabetes Mellitus; Coronary Heart Disease
University of Oxford
2007-01 PHASE3
NCT00926055 WITHDRAWN
Atherosclerosis
Korea University
2011-09
NCT01154036 COMPLETED
Hypercholesterolemia
Organon and Co
2010-07 PHASE3
NCT01035320 COMPLETED
Diabetes Mellitus; Impaired Renal Function
Karolinska Institutet
2006-01 PHASE4
NCT01375764 COMPLETED
Hyperlipidemia
Amgen
2011-07-28 PHASE2
NCT01370603 COMPLETED
Hypercholesterolemia
Organon and Co
2011-09 PHASE3
NCT00867165 COMPLETED
Primary Hypercholesterolemia
Organon and Co
2009-05-21 PHASE3
NCT01370590 COMPLETED
Hypercholesterolemia
Organon and Co
2011-09 PHASE3
NCT01375777 COMPLETED
Hyperlipidemia
Amgen
2011-07-06 PHASE2
NCT02205775 TERMINATED
Stable Coronary Artery Disease Undergoing PCI
G. d'Annunzio University
2010-05 PHASE3
NCT01597700 COMPLETED
Hypercholesterolaemia
GlaxoSmithKline
2012-01-13 PHASE1
NCT02304926 COMPLETED
Dyslipidemia
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
2009-01
NCT00843661 UNKNOWN
HIV; Hyperlipidemia; HIV Infections
Ospedale di Circolo - Fondazione Macchi
2009-03 PHASE4
NCT01086020 UNKNOWN
Coronary Artery Disease
Shanghai Jiao Tong University School of Medicine
2010-01 PHASE4
NCT00819403 COMPLETED
Metabolic Syndrome
University of Maryland, Baltimore
2009-01 PHASE4
NCT01236430 COMPLETED
Hyperlipidemia
Organon and Co
2011-02 PHASE1
NCT00548145 TERMINATED
Alzheimer Disease; Hypercholesterolemia
Osaka University
2007-11
NCT00965055 TERMINATED
High Cholesterol; Coronary Artery Disease
University of California, San Diego
2009-09 PHASE3
NCT01185236 UNKNOWN
Type 2 Diabetes Mellitus Without Insulin Treatment
Seoul National University Hospital
2010-09 PHASE4
NCT01218204 COMPLETED
Dyslipidaemias; Dyslipidemias
GlaxoSmithKline
2010-09-14 PHASE2
NCT00955227 COMPLETED
Hypercholesterolemia; Hyperlipidemia
University of Manitoba
2009-07
NCT00862251 COMPLETED
Cardiovascular Disorder; Diabetes Mellitus
Organon and Co
2009-04 PHASE3
NCT01241097 UNKNOWN
Endothelial Function
Federal University of Bahia
2010-03
NCT00972829 UNKNOWN
Hypercholesterolemia
Bronx VA Medical Center
2009-09 PHASE4
NCT01112423 COMPLETED
Dyslipidemia
Bristol-Myers Squibb
2010-06 PHASE2
NCT00687076 COMPLETED
Peripheral Arterial Disease
Baylor College of Medicine
2004-04 PHASE4
NCT00817843 COMPLETED
Metabolic Syndrome
dr.Frank L.J. Visseren
2009-04 PHASE4
NCT00738985 WITHDRAWN
Cardiovascular Diseases; Hyperlipidemia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2009-11 PHASE4
NCT00782184 COMPLETED
Hypercholesterolemia
Organon and Co
2008-11 PHASE3
NCT00477204 COMPLETED
Type 1 Diabetes Mellitus; Dyslipidemia
University of Colorado, Denver
2007-05 PHASE2
NCT00125593 COMPLETED
Kidney Disease, Chronic
University of Oxford
2003-06 PHASE4
NCT00738972 TERMINATED
Hypertension
Fundación Lindavista del Corazón AC
2008-01 PHASE3
NCT00871351 COMPLETED
Primary Hypercholesterolemia
Organon and Co
2009-02-01 PHASE4
NCT01384058 COMPLETED
Diabetes Mellitus Type 2; Hypercholesterolemia
University Hospital Freiburg
2007-11 PHASE4
NCT00783263 COMPLETED
Hypercholesterolemia
Organon and Co
2008-11 PHASE3
NCT00932620 COMPLETED
Hypercholesterolemia
University of Ioannina
2009-06 PHASE4
NCT00664469 TERMINATED
Hypercholesterolemia
Sunnybrook Health Sciences Centre
2007-08 PHASE3
NCT00481351 COMPLETED
Coronary Heart Disease
University of Sao Paulo
2007-06 PHASE4
NCT00905905 COMPLETED
Myocardial Infarction
Brasilia Heart Study Group
2009-05 PHASE4
NCT00587678 COMPLETED
Peripheral Artery Disease
University of Virginia
2006-01
NCT00863265 COMPLETED
Hypercholesterolemia; Coronary Heart Disease
Washington University School of Medicine
2009-06 EARLY_PHASE1
NCT00699023 COMPLETED
Postprandial Lipemia; Type 2 Diabetes
Federico II University
2008-06 PHASE4
NCT00397657 TERMINATED
Atherosclerosis
Walter Reed Army Medical Center
2006-11 PHASE4
NCT00634140 WITHDRAWN
Chronic Acalculous Cholecystitis
Indiana University
2009-08
NCT00654628 COMPLETED
Hypercholesterolemia
Organon and Co
2007-08-01 PHASE4
NCT00810303 COMPLETED
Pharmacokinetics; Drug Interactions; Pharmacodynamics; Intestinal Transporter Expression
University Medicine Greifswald
2009-03 PHASE1
NCT00861731 UNKNOWN
Hypercholesterolemia; Chronic Nephropathy
Azienda Ospedaliero Universitaria di Sassari
2008-11 PHASE4
NCT00653523 COMPLETED
Hypercholesterolemia
Organon and Co
2007-12-01 PHASE3
NCT00654095 COMPLETED
Hypercholesterolemia
Organon and Co
2007-12-01 PHASE3
NCT00725829 UNKNOWN
Acute Coronary Syndrome
Jagiellonian University
2008-06
NCT01008345 COMPLETED
Coronary Artery Disease; Diabetes
Hotel Dieu de France Hospital
2008-09 PHASE4
NCT00762164 COMPLETED
Hypercholesterolemia
Bronx VA Medical Center
2007-03 PHASE4
NCT00701727 COMPLETED
Hypercholesterolemia
Radiant Research
2008-06 PHASE4
NCT00485121 COMPLETED
Metabolic Syndrome; Obesity; Coronary Artery Disease
Canadian Collaborative Research Network
2007-04
NCT00535405 COMPLETED
Hypercholesterolemia
Organon and Co
2007-11 PHASE3
NCT00474123 COMPLETED
Stable Angina
University of Sao Paulo
2006-01
NCT00442897 COMPLETED
Hypercholesterolemia
Organon and Co
2006-09 PHASE4
NCT00559962 COMPLETED
Hyperlipidemia
Aegerion Pharmaceuticals, Inc.
2007-10 PHASE2
NCT00639158 COMPLETED
Dyslipidemias; Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia
Abbott
2008-02 PHASE3
NCT00418834 COMPLETED
Hypercholesterolemia
Organon and Co
2007-01 PHASE3
NCT00677248 COMPLETED
Hypercholesterolemia
Karo Bio AB
2008-04 PHASE2
NCT00525824 COMPLETED
Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis
AstraZeneca
2007-08 PHASE3
NCT00762229 COMPLETED
Hypercholesterolemia
Bronx VA Medical Center
2007-07
NCT00496730 COMPLETED
Hypercholesterolemia
Organon and Co
2007-07 PHASE3
NCT00772551 COMPLETED
HIV
St Stephens Aids Trust
2008-06 PHASE1
NCT00409773 COMPLETED
Hypercholesterolemia; Metabolic Syndrome
Organon and Co
2007-01 PHASE3
NCT00462748 COMPLETED
Hypercholesterolemia
Organon and Co
2007-03 PHASE3
NCT00681525 COMPLETED
Pharmacokinetics
Abbott
2008-04 PHASE1
NCT00753883 COMPLETED
Hyperlipidemia
Merck Sharp & Dohme LLC
2006-07 PHASE4
NCT00092677 COMPLETED
Aortic Stenosis
Organon and Co
2001-01 PHASE3
NCT00376246 COMPLETED
Endothelial Dysfunction
University of California, San Diego
2006-09 PHASE4
NCT00423579 COMPLETED
Hypercholesterolemia; Coronary Disease
Organon and Co
2006-07-01 PHASE4
NCT00479713 COMPLETED
Hypercholesterolemia
Organon and Co
2007-02-01 PHASE3
NCT00988364 COMPLETED
Metabolic Syndrome
Baylor College of Medicine
2007-03 PHASE4
NCT00276484 COMPLETED
Hypercholesterolemia
Organon and Co
2006-02 PHASE3
NCT00794677 COMPLETED
Hypercholesterolemia
UCSF Benioff Children's Hospital Oakland
2006-06 PHASE4
NCT00271817 COMPLETED
Hypercholesterolemia
Organon and Co
2005-12 PHASE3
NCT00276458 COMPLETED
Hypercholesterolemia
Organon and Co
2006-02 PHASE3
NCT00203476 COMPLETED
Hyperlipidemia; Hypercholesterolemia
Tuscaloosa Research & Education Advancement Corporation
2005-05 PHASE4
NCT00560170 COMPLETED
Atherosclerosis
National Cheng-Kung University Hospital
2007-09 PHASE4
NCT00359281 COMPLETED
Healthy
Aegerion Pharmaceuticals, Inc.
2006-03 PHASE2
NCT00621699 COMPLETED
Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression
University Medicine Greifswald
2007-09 PHASE1
NCT00166504 COMPLETED
Hypercholesterolemia
Organon and Co
2005-10 PHASE4
NCT00440154 COMPLETED
Hypercholesterolemia
Sanofi
2007-02 PHASE2
NCT00157924 COMPLETED
Hypercholesterolemia
Organon and Co
2005-11 PHASE4
NCT00814723 COMPLETED
Hypercholesterolemia
Medical University of Graz
2005-09 PHASE4
NCT02089867 COMPLETED
Coronary Artery Disease
Jose Rocha Faria Neto
2006-10 PHASE2; PHASE3
NCT00652431 COMPLETED
Hypercholesterolemia; Hyperlipidemia
Organon and Co
2007-05 PHASE1
NCT00652327 COMPLETED
Hypercholesterolemia
Organon and Co
2005-12 PHASE4
NCT00132717 COMPLETED
Hypercholesterolemia
Organon and Co
2005-01-01 PHASE3
NCT00129402 COMPLETED
Hypercholesterolemia
Organon and Co
2005-08 PHASE3
NCT00621101 COMPLETED
Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression
University Medicine Greifswald
2007-04 PHASE1
NCT00395603 TERMINATED
Cardiovascular Diseases; Diabetes Mellitus
Organon and Co
2006-09 PHASE3
NCT00652847 COMPLETED
Hypercholesterolemia
Organon and Co
2005-05 PHASE4
NCT00385658 COMPLETED
Dyslipidemia
Novartis
2006-08 PHASE4
NCT00423488 COMPLETED
Hypercholesterolemia; Diabetes Mellitus, Type 2; Coronary Disease
Organon and Co
2005-07-12 PHASE3
NCT00166530 COMPLETED
Atherosclerosis
Organon and Co
2005-11 PHASE4
NCT00405067 COMPLETED
Hypercholesterolemia
Aegerion Pharmaceuticals, Inc.
2006-05 PHASE2
NCT00268697 COMPLETED
Hypercholesterolemia
Takeda
2005-10 PHASE3
NCT00413972 COMPLETED
Hypercholesterolemia
Organon and Co
2006-04 PHASE3
NCT00101439 COMPLETED
Hypercholesterolemia
Organon and Co
2005-11-10 PHASE3
NCT00319449 COMPLETED
Hypercholesterolemia; Coronary Arteriosclerosis
Organon and Co
2005-09 PHASE4
NCT00202904 COMPLETED
Hypercholesterolemia; Coronary Heart Disease
Organon and Co
2005-05 PHASE4
NCT01424891 COMPLETED
Type 2 Diabetes; Inflammation
Heidelberg University
2004-04
NCT00651014 TERMINATED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2004-01 PHASE4
NCT01103648 COMPLETED
Prediabetes; Hypercholesterolemia; Inflammation; Cardiovascular Risk
Federal University of São Paulo
2005-06
NCT00552097 COMPLETED
Atherosclerosis; Hypercholesterolemia; Hyperlipoproteinemia Type II
Organon and Co
2002-06-01 PHASE3
NCT00328523 COMPLETED
Hypercholesterolaemia; Hyperlipidaemia
Organon and Co
2004-06 PHASE3
NCT00651560 COMPLETED
Hyperlipidemia
Organon and Co
2005-11-01 PHASE3
NCT00110435 COMPLETED
Type 2 Diabetes Mellitus; Hypercholesterolemia
Organon and Co
2005-05 PHASE3
NCT00738296 COMPLETED
Cardiovascular Diseases
Hospital Universitario 12 de Octubre
2005-04 PHASE4
NCT00395473 COMPLETED
Hypercholesterolemia
Organon and Co
2005-03 PHASE3
NCT00457275 COMPLETED
Hypercholesterolemia
Organon and Co
2005-04 PHASE3
NCT00541697 COMPLETED
Diabetes Mellitus, Type 2
Organon and Co
2005-01-19 PHASE3
NCT00092898 COMPLETED
Lipid Metabolism, Inborn Errors; Heart Disease
Organon and Co
2004-10 PHASE3
NCT00093899 COMPLETED
Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
2004-11 PHASE3
NCT00171288 COMPLETED
Dyslipidemia
Novartis
2003-08 PHASE3
NCT00651378 TERMINATED
Hypercholesterolemia; Atherosclerosis; Coronary Artery Disease
Organon and Co
2004-09-01 PHASE4
NCT00092833 TERMINATED
Hypercholesterolemia, Familial; Lipid Metabolism, Inborn Errors
Organon and Co
2002-07 PHASE3
NCT00651963 COMPLETED
Lipid Metabolism Disorder
Organon and Co
2004-09 PHASE4
NCT00652717 COMPLETED
Cardiovascular Disorder
Organon and Co
2005-02-01 PHASE4
NCT00650819 COMPLETED
Hypercholesterolemia
Organon and Co
2004-06-01 PHASE3
NCT00650689 COMPLETED
Hypercholesterolemia; Atherosclerosis; Coronary Artery Disease
Organon and Co
2003-05 PHASE3
NCT00090298 COMPLETED
Hypercholesterolemia
Organon and Co
2004-04 PHASE3
NCT00651404 COMPLETED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2004-01 PHASE3
NCT00092573 COMPLETED
Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
2003-04 PHASE3
NCT00090168 COMPLETED
Hypercholesterolemia; Atherosclerotic Disease; Coronary Disease
Organon and Co
2004-01-27 PHASE3
NCT00650663 COMPLETED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2003-10-01 PHASE4
NCT00651391 TERMINATED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2003-10-01 PHASE3
NCT00653913 COMPLETED
Hypercholesterolemia
Organon and Co
2004-03 PHASE1
NCT00653835 COMPLETED
Hypercholesterolaemia; Atherosclerosis
Organon and Co
2003-09-01 PHASE4
NCT00653796 COMPLETED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2003-09-01 PHASE4
NCT00651274 COMPLETED
Atherosclerosis; Hypercholesterolemia; Coronary Heart Disease
Organon and Co
2003-04-01 PHASE4
NCT00652444 COMPLETED
Hypercholesterolemia
Organon and Co
2003-09 PHASE4
NCT00092625 COMPLETED
Hypercholesterolemia; Coronary Disease
Organon and Co
2003-03 PHASE3
NCT00092638 COMPLETED
Hypercholesterolemia; Coronary Disease
Organon and Co
2003-05 PHASE3
NCT00317993 COMPLETED
Healthy Men
University of Cologne
2004-04 PHASE4
NCT00092599 COMPLETED
Hypercholesterolemia; Coronary Disease
Organon and Co
2003-02 PHASE3
NCT00092612 COMPLETED
Hypercholesterolemia; Coronary Disease
Organon and Co
2003-05 PHASE3
NCT00652301 COMPLETED
Cholesterol
Organon and Co
2003-07 PHASE3
NCT00092690 COMPLETED
Hypercholesterolemia
Organon and Co
2003-06 PHASE3
NCT00653276 COMPLETED
Cholesterol
Organon and Co
2003-11 PHASE1
NCT00092560 COMPLETED
Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
2002-12 PHASE3
NCT00092586 COMPLETED
Hypercholesterolemia
Organon and Co
2002-09 PHASE3
NCT00157911 COMPLETED
Hypercholerolemia
Organon and Co
2002-12 PHASE3
NCT00092664 COMPLETED
Hypercholesterolemia
Organon and Co
2003-01 PHASE3
NCT03885921 COMPLETED
Hypercholesterolemia
Organon and Co
2000-10-25 PHASE3
NCT00092651 COMPLETED
Hypercholesterolemia
Organon and Co
2002-09 PHASE3
NCT00651144 COMPLETED
Hypercholesterolemia; Atherosclerosis
Organon and Co
2003-03 PHASE1
NCT00092716 COMPLETED
Hypercholesterolemia
Organon and Co
2002-05 PHASE3
NCT00551447 COMPLETED
Coronary Disease
Organon and Co
2002-01 PHASE3
NCT03882996 COMPLETED
Hypercholesterolemia
Organon and Co
2000-10-06 PHASE3
NCT00551876 COMPLETED
Diabetes Mellitus, Type 2
Organon and Co
2001-12 PHASE3
NCT03882892 COMPLETED
Hypercholesterolemia
Organon and Co
2001-02-02 PHASE3
NCT03867318 COMPLETED
Hypercholesterolemia
Organon and Co
2000-04-24 PHASE3
NCT00092820 COMPLETED
Lipid Metabolism, Inborn Errors; Heart Disease
Organon and Co
2001-02-12 PHASE3
NCT00092807 COMPLETED
Lipid Metabolism, Inborn Errors; Heart Disease
Organon and Co
2001-02-12 PHASE3
NCT03867110 COMPLETED
Hypercholesterolemia
Organon and Co
2000-03-06 PHASE3
NCT03882905 COMPLETED
Primary Hypercholesterolemia
Organon and Co
2001-01-31 PHASE3
NCT03884452 COMPLETED
Familial Hypercholesterolemia
Organon and Co
2000-05-03 PHASE3
NCT00099684 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2005-11
NCT00099996 COMPLETED
Heart Diseases; Metabolism, Inborn Errors
National Heart, Lung, and Blood Institute (NHLBI)
2004-12 PHASE3
NCT00189085 COMPLETED
Metabolic Syndrome
UMC Utrecht
2004-12 PHASE4
NCT00433823 UNKNOWN
Coronary Heart Disease; Diabetes Mellitus; Non-Coronary Atherosclerotic Disease; Hypercholesterolemia
Abant Izzet Baysal University
2007-01 PHASE4
NCT00195793 COMPLETED
Hyperlipidemia
Abbott
2004-08 PHASE3
NCT00449410 COMPLETED
Atrial Fibrillation; Neuropsychology; Magnetic Resonance Imaging; Inflammation; Hemostasis
Radboud University Medical Center
2005-05 PHASE4
NCT00475826 UNKNOWN
Heterozigous Familial Hypercholesterolemia
University of Sao Paulo
2007-04
NCT00157482 COMPLETED
Type 2 Diabetes
Mario Negri Institute for Pharmacological Research
2005-01 PHASE2
NCT00566267 COMPLETED
Hyperlipidemia
Merck Sharp & Dohme LLC
2006-04 PHASE2; PHASE3
NCT00461968 COMPLETED
Cholesterol, LDL
University of Texas Southwestern Medical Center
2005-02
NCT00045812 COMPLETED
Lipoidosis
National Heart, Lung, and Blood Institute (NHLBI)
2001-03 PHASE2
NCT00349284 COMPLETED
Hyperlipidemia Combined
Solvay Pharmaceuticals
2005-01 PHASE3
NCT00079638 COMPLETED
Dyslipidemia; Coronary Heart Disease; Atherosclerosis; Stroke; Diabetes
Kos Pharmaceuticals
2004-04 PHASE4
NCT00267267 TERMINATED
Hyperlipidemia; Dyslipidemia
Pfizer
2006-01 PHASE3
NCT00653445 COMPLETED
Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis
AstraZeneca
2004-06 PHASE3
NCT00185107 COMPLETED
Hypercholesterolemia
Daiichi Sankyo
2005-03 PHASE4
NCT00466401 COMPLETED
Hypercholesterolemia
Ziv Hospital
2005-02 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-08-07)

Check the Ezetimibe (SCH-58235) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ezetimibe selectively binds to Niemann-Pick C1-Like 1 (NPC1L1) protein on gastrointestinal epithelial cells and hepatocytes, inhibiting intestinal and biliary cholesterol absorption into enterocytes. This inhibition reduces cholesterol delivery to the liver and depletes hepatic stores, upregulating hepatic low-density lipoprotein receptor expression and lowering plasma cholesterol levels, which directly underpins its therapeutic application in treating hypercholesterolemia and coronary artery disease evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.