Zetia

(Ezetimibe)

ApprovedSmall molecule

Ezetimibe is used to lower cholesterol levels in the blood by blocking the absorption of cholesterol from food in the digestive system. It's often used together with other cholesterol-lowering medications to help reduce the risk of heart disease and stroke.[2] Zetia is currently approved and in use across 15 indications[4].[1]

Zetia is one of 266 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

212

Total Trials

Active Trials

265

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseUnknown

RigidityActive, not recruiting

Combined HyperlipidemiaActive, not recruiting

Acute Myocardial InfarctionCompleted

SitosterolemiaActive, not recruiting

Metabolic DiseaseActive, not recruiting

Kidney TransplantActive, not recruiting

Inherited Lipid Metabolism DisorderUnknown

Peripheral Arterial DiseaseCompleted

Prostate CancerRecruiting

Cardiovascular DiseasePreclinical

Unknown

RigidityApproved

Active, not recruiting

Combined HyperlipidemiaPreclinical

Active, not recruiting

Acute Myocardial InfarctionApproved

Completed

SitosterolemiaPreclinical

Active, not recruiting

Metabolic DiseasePreclinical

Active, not recruiting

Kidney TransplantApproved

Active, not recruiting

Inherited Lipid Metabolism DisorderPreclinical

Unknown

Peripheral Arterial DiseaseApproved

Completed

Prostate CancerPhase 2

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Phase 3

20 2

Zetia

OOrganon and Co

Approved

1 3

Androgen Deprivation Therapy

Johnson & Johnson

Phase 3

48 4

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

7 5

LHRH Agonist

Roche

Phase 3

10 6

Lutetium Lu-177 PNT2002

JJonsson Comprehensive Cancer Center

Phase 3

4 7

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 8

HC-1119

HHinova Pharmaceuticals Inc.

Phase 3

2 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Hypercholesterolemia

NCT07442630

Q3 2027

Post-ApprovalRecruiting

Statin

NCT04499859

Recruiting

Cardiovascular Disease

NCT06858332

Q2 2028

Phase 2Recruiting

Prostate Cancer

NCT06437574

Clinical

Trials by Indication[1]

Hypercholesterolemia41 trials

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT02715726·615 enrolled

A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT02260648·149 enrolled

Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

Completed·OOrganon and Co··NCT00704535·4,105 enrolled

Show 38 more trials

A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00101439·58 enrolled

Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Completed·OOrganon and Co·Phase 3·NCT00653523·151 enrolled

A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)

Completed·OOrganon and Co··NCT00704444·11,332 enrolled

The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia

Completed·AAegerion Pharmaceuticals, Inc.·Phase 2·NCT00405067·60 enrolled

Effect of Ezetimibe Plus Simvastatin on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (Study P03336)

Terminated·OOrganon and Co·Phase 3·NCT00651391·28 enrolled

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)

Completed·OOrganon and Co·Phase 3·NCT00650689·122 enrolled

Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)

Terminated·OOrganon and Co·Phase 4·NCT00651378·87 enrolled

Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)

Completed·OOrganon and Co·Phase 3·NCT00413972·392 enrolled

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

Completed·OOrganon and Co·Phase 4·NCT00650663·247 enrolled

Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

Completed·OOrganon and Co·Phase 3·NCT00651404·137 enrolled

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT06450366·301 enrolled

Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00650819·240 enrolled

A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)

Completed·OOrganon and Co··NCT00705211·1,794 enrolled

Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Completed·OOrient Pharma Co., Ltd.·Phase 3·NCT04643093·390 enrolled

A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

Completed·OOrganon and Co·Phase 3·NCT02748057·135 enrolled

Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

Completed· Novartis logo

Novartis·Phase 3·NCT05763875·350 enrolled

The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Completed·SShin Poong Pharmaceutical Co. Ltd.·Phase 3·NCT03288038·382 enrolled

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01644188·720 enrolled

A Long-term Safety and Tolerability Study of Ezetimibe Plus Atorvastatin in Participants With Coronary Heart Disease, Multiple Risk Factors, or Hypercholesterolemia Not Controlled by Atorvastatin (P01418/MK-0653-032)

Completed·OOrganon and Co·Phase 3·NCT03882996·432 enrolled

Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)

Completed·OOrganon and Co·Phase 4·NCT00651274·144 enrolled

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT01644474·103 enrolled

Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00652847·1,140 enrolled

A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT00440154·206 enrolled

A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)

Completed·OOrganon and Co·Phase 3·NCT03882905·769 enrolled

A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

Completed·OOrganon and Co·Phase 4·NCT01611883·152 enrolled

Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01709513·314 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT02476006·998 enrolled

An Efficacy and Safety Study of Ezetimibe (MK-0653, SCH 58235) in Addition to Atorvastatin Compared to Placebo in Participants With Primary Hypercholesterolemia (MK-0653-013)

Completed·OOrganon and Co·Phase 3·NCT03867110·628 enrolled

A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)

Completed·OOrganon and Co·Phase 3·NCT02741245·321 enrolled

Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00423488·93 enrolled

A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

Completed·OOrganon and Co·Phase 3·NCT02550288·309 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

Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)

Terminated·OOrganon and Co·Phase 4·NCT00651014·82 enrolled

Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia

Unknown status·PPoliclinico Casilino ASL RMB·Phase 4·NCT04659525·50 enrolled

Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)

Completed·OOrganon and Co·Phase 3·NCT00867165·138 enrolled

A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 3·NCT02749994·396 enrolled

Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

Completed·OOrganon and Co·Phase 3·NCT00654095·146 enrolled

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00871351·125 enrolled

Cholesterol15 trials

Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

Completed·OOrganon and Co·Phase 4·NCT00653835·153 enrolled

A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

Completed·OOrganon and Co·Phase 3·NCT00462748·786 enrolled

Physiological Study of Human Cholesterol Metabolism and Excretion

Completed·—·Phase 1·NCT01603758·132 enrolled

Show 12 more trials

Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

Completed· Pfizer logo

Pfizer·Phase 2·NCT02055976·218 enrolled

Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01807078·200 enrolled

Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02234544·52 enrolled

A Study of LY3015014 in Participants With High Cholesterol

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01890967·527 enrolled

Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels

Completed·UUniversity of Manitoba·N/A·NCT00955227·60 enrolled

Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT01941836·349 enrolled

A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT02227784·366 enrolled

Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

Completed·HHotel Dieu de France Hospital·Phase 4·NCT01008345·100 enrolled

Addition of Ezetimibe (Ezetrol®) to Ongoing Therapy With Rosuvastatin (Crestor®) in HIV Positive Patients Not Reaching Cholesterol Targets

Completed·UUniversity of British Columbia·N/A·NCT00908011·43 enrolled

Effects of Ezetimibe on the Absorption of Oxidized Cholesterol

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 4·NCT00794677·26 enrolled

A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00652301·40 enrolled

Phytosterols, Ezetimibe, and Cholesterol Metabolism

Completed·WWashington University School of Medicine·Phase 1·NCT00863265·22 enrolled

Statin10 trials

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07182383·58 enrolled

Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

Completed·OOrganon and Co·Phase 3·NCT03882892·400 enrolled

Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI

Recruiting·KKiyuk Chang, MD,PhD·Phase 4·NCT04499859·3,548 enrolled

Show 7 more trials

Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia

Unknown status·—·Phase 4·NCT00972829·30 enrolled

Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01490229·100 enrolled

LDL Receptor Under Ezetimibe and Simvastatin

Completed·UUniversity of Cologne·Phase 4·NCT00317993·60 enrolled

Plant Sterols Effect on Previous Statin Therapy

Completed·JJose Rocha Faria Neto·Phase 2/3·NCT02089867·47 enrolled

Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

Completed·UUniversity of Sao Paulo·Phase 4·NCT00481351·25 enrolled

Anti-inflammatory Effects of Simvastatin

Terminated·Pparesh Dandona·Phase 4·NCT04638400·10 enrolled

Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07201545·58 enrolled

Atorvastatin9 trials

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00166504·203 enrolled

Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)

Completed·OOrganon and Co·Phase 4·NCT00653796·148 enrolled

Ezetimibe and Atorvastatin Therapy on TCFA

Unknown status·XXijing Hospital·Phase 4·NCT02588235·100 enrolled

Show 6 more trials

A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin

Completed·AAbbott·Phase 3·NCT00195793·174 enrolled

A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07235189·58 enrolled

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07268625·58 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin

Completed· GSK logo

GSK·Phase 2·NCT01218204·287 enrolled

A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

Completed·AAbbott·Phase 1·NCT00681525·18 enrolled

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

Completed·OOrganon and Co·Phase 3·NCT00276484·579 enrolled

Heart Disease7 trials

Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00319449·22 enrolled

Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

Completed·OOrganon and Co·Phase 3·NCT00418834·1,053 enrolled

A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Completed·OOrganon and Co·Phase 3·NCT00535405·1,289 enrolled

Show 4 more trials

Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)

Completed·OOrganon and Co··NCT00730132·712 enrolled

Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)

Completed·OOrganon and Co··NCT01381679·1,682 enrolled

Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)

Completed·OOrganon and Co·Phase 3·NCT03867318·621 enrolled

Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)

Completed·OOrganon and Co·Phase 4·NCT00202904·81 enrolled

63 more indications

Type 2 Diabetes6 trials

Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes

Completed·UUniversity Hospital Freiburg·Phase 4·NCT01384058·41 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 4·NCT02642159·413 enrolled

Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe

Unknown status·SSteno Diabetes Center Copenhagen·Phase 3·NCT04589351·60 enrolled

Show 3 more trials

Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Completed·FFederico II University·Phase 4·NCT00699023·13 enrolled

Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03531905·242 enrolled

CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

Completed·NNYU Langone Health·Phase 4·NCT04369664·151 enrolled

Antibody5 trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

Completed· Amgen logo

Amgen·Phase 2·NCT01375764·160 enrolled

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Completed· Amgen logo

Amgen·Phase 3·NCT01763905·307 enrolled

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

Completed· Amgen logo

Amgen·Phase 3·NCT02634580·61 enrolled

Show 2 more trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

Completed· Amgen logo

Amgen·Phase 3·NCT01984424·511 enrolled

Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

Completed· Amgen logo

Amgen·Phase 3·NCT01516879·905 enrolled

Efficacy and Safety5 trials

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00525824·1,743 enrolled

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01730040·355 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03001076·269 enrolled

Show 2 more trials

Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

Completed· Daewon Pharmaceutical Co., Ltd. logo

Daewon Pharmaceutical Co., Ltd.·Phase 3·NCT05970679·252 enrolled

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Completed·EEsperion Therapeutics, Inc.·Phase 2·NCT03051100·63 enrolled

Effectiveness4 trials

Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00099684·44 enrolled

Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)

Completed·OOrganon and Co··NCT00726856·1,200 enrolled

A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)

Completed·OOrganon and Co·Phase 3·NCT01370590·406 enrolled

Show 1 more trial

A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)

Completed·OOrganon and Co·Phase 3·NCT01370603·328 enrolled

Chronic Hepatitis4 trials

Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection in Liver Transplant Candidates (EZE-2)

Unknown status·PPontificia Universidad Catolica de Chile·Phase 4·NCT02768545·12 enrolled

Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

Unknown status·—·Phase 2·NCT03105310·20 enrolled

Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C

Terminated·VVA Office of Research and Development·Phase 2·NCT02971033·2 enrolled

Show 1 more trial

Pilot Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection

Unknown status·PPontificia Universidad Catolica de Chile·Phase 1·NCT02126137·20 enrolled

Safety and Efficacy3 trials

Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

Completed·AAbbott·Phase 3·NCT00639158·543 enrolled

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH

Completed·AAkeso·Phase 2·NCT03933293·10 enrolled

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

Completed·EEsperion Therapeutics, Inc.·Phase 3·NCT03337308·382 enrolled

Metabolic Syndrome3 trials

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00409773·1,143 enrolled

Effects of Ezetimibe Add-On to Statin Therapy on Adipokine Production in Obese and Metabolic Syndrome Patients With Atherosclerosis

Completed·CCanadian Collaborative Research Network·N/A·NCT00485121·50 enrolled

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.

Completed·—·Phase 4·NCT00988364·30 enrolled

Myocardial Infarction3 trials

Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

Completed·BBrasilia Heart Study Group·Phase 4·NCT00905905·40 enrolled

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Withdrawn·IImperial College London·Phase 4·NCT03750760

Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)

Completed·OOrganon and Co·Phase 4·NCT00652717·280 enrolled

Cardiovascular Disease3 trials

Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00862251·808 enrolled

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Recruiting· Novartis logo

Novartis··NCT06858332·2,382 enrolled

In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

Completed· Novartis logo

Novartis··NCT05974345·204,691 enrolled

Dyslipidemia3 trials

Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia.

Completed· Takeda logo

Takeda·Phase 3·NCT00268697·1,267 enrolled

Ezetimibe and Simvastatin in Dyslipidemia of Diabetes

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT00157482·108 enrolled

Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study

Unknown status·MMisr University for Science and Technology··NCT05080140·3 enrolled

Acute Coronary Syndrome3 trials

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

Completed· Sanofi logo

Sanofi·Phase 4·NCT02984982·206 enrolled

The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome

Unknown status·YYokohama City University Medical Center·Phase 4·NCT01068093·120 enrolled

Hypolipemic Treatment in Acute Coronary Syndrome (ACS): Antithrombotic Effects

Unknown status·JJagiellonian University·N/A·NCT00725829·100 enrolled

Interaction3 trials

Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)

Completed·OOrganon and Co·Phase 1·NCT00651144·40 enrolled

MD Ezetimibe Cyclosporine Interaction (0653-057)

Completed·OOrganon and Co·Phase 1·NCT00653276·13 enrolled

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20mg and Ezetimibe10mg, Fixed Dose vs Individual Components

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 1·NCT04895059·36 enrolled

Efficacy3 trials

Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00653445

Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL

Completed·KKos Pharmaceuticals·Phase 4·NCT00079638·300 enrolled

A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06742853·81 enrolled

Drug Interactions3 trials

Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Completed·AAegerion Pharmaceuticals, Inc.·Phase 2·NCT00359281·125 enrolled

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Completed·NNewAmsterdam Pharma·Phase 1·NCT06547359·94 enrolled

Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 1·NCT02127320·24 enrolled

Familial Hypercholesterolemia3 trials

Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)

Completed·OOrganon and Co·Phase 3·NCT03884452·50 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510884·153 enrolled

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT02890992·42 enrolled

Peripheral Arterial Disease2 trials

Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)

Completed·—·Phase 4·NCT00687076·102 enrolled

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Completed·UUniversity of Virginia·N/A·NCT00587678·85 enrolled

Hyperlipidemia2 trials

A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00093899·611 enrolled

Ezetimibe and Orlistat Affect the Intestinal Flora of Hyperlipidemia.

Unknown status·FFifth Affiliated Hospital of Xinjiang Medical University··NCT03884127·58 enrolled

High Cardiovascular Risk2 trials

A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00479713·618 enrolled

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

Completed·OOrganon and Co·Phase 3·NCT01154036·1,547 enrolled

Atherosclerosis2 trials

Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis

Terminated·WWalter Reed Army Medical Center·Phase 4·NCT00397657·400 enrolled

Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)

Completed·OOrganon and Co·Phase 3·NCT00552097·720 enrolled

Treatment2 trials

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01730053·305 enrolled

INdians Followed for INtensive Lipid Lowering Treatment and Its safetY

Terminated·SSunnybrook Health Sciences Centre·Phase 3·NCT00664469·64 enrolled

Drug Therapy2 trials

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

Completed· Amgen logo

Amgen·Phase 2·NCT01375777·411 enrolled

Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

Completed· Amgen logo

Amgen·Phase 3·NCT01763827·615 enrolled

Combination Therapy2 trials

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

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00185107·45 enrolled

Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00651963·80 enrolled

Sitosterolemia2 trials

Higher-Dose Ezetimibe to Treat Homozygous Sitosterolemia

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00099996·3 enrolled

Sitosterolemia Metabolism

Completed·UUniversity of Manitoba·N/A·NCT01584206·8 enrolled

Randomized2 trials

Randomized Study of Obicetrapib in Combination With Ezetimibe

Completed·NNewAmsterdam Pharma·Phase 2·NCT04770389·112 enrolled

Randomized Trial Comparing Colesevelam vs. Ezetimibe

Completed·LLMC Diabetes & Endocrinology Ltd.·Phase 4·NCT02682680·200 enrolled

Non-Alcoholic Steatohepatitis2 trials

Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

Completed·UUniversity of California, San Diego·Phase 2·NCT01766713·50 enrolled

Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

Unknown status·UUniversity of Palermo·Phase 4·NCT01950884·45 enrolled

Statins2 trials

Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

Completed·OOrganon and Co··NCT00705081·453 enrolled

Ezetimibe in Patients Hypo-responsive to Statins

Terminated·UUniversity of California, San Diego·Phase 3·NCT00965055·2 enrolled

LDL-cholesterol2 trials

Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease

Unknown status·—·N/A·NCT03355027·60 enrolled

Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

Completed·—·N/A·NCT00762229·39 enrolled

TIA2 trials

Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.

Completed· GSK logo

GSK·Phase 1·NCT01597700·52 enrolled

Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

Completed·YYonsei University·Phase 4·NCT05661552·108 enrolled

Systemic Inflammation1 trial

Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty

Terminated·GG. d'Annunzio University·Phase 3·NCT02205775·280 enrolled

Tics1 trial

A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

Completed·AAlvogen Korea·Phase 1·NCT02730689·66 enrolled

Metabolic Disease1 trial

Metagenomic Analysis of Human Gut Microbiota in Patients With Metabolic Diseases Including Diabetes

Unknown status·YYonsei University··NCT03204799·150 enrolled

Adolescent1 trial

Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

Completed·OOrganon and Co·Phase 3·NCT00129402·248 enrolled

Aortic Stenosis1 trial

An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00092677·1,873 enrolled

Left Ventricular Hypertrophy1 trial

Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

Terminated·FFundación Lindavista del Corazón AC·Phase 3·NCT00738972·12 enrolled

Newly Diagnosed1 trial

Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00654628·173 enrolled

Coronary Artery Disease1 trial

EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)

Completed·OOrganon and Co·Phase 4·NCT00166530·367 enrolled

Rigidity1 trial

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Completed·HHospital Universitario 12 de Octubre·Phase 4·NCT00738296·90 enrolled

Diabetes1 trial

The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes

Unknown status·—·N/A·NCT03771053·240 enrolled

TED1 trial

A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)

Completed·OOrganon and Co·Phase 1·NCT01236430·200 enrolled

Kidney Transplant1 trial

The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02103049·80 enrolled

Function1 trial

The Influence of Ezetimibe on Gallbladder Function

Withdrawn·IIndiana University·N/A·NCT00634140

Completed·RRadiant Research·Phase 4·NCT00701727·31 enrolled

Double-blind1 trial

Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

Completed·OOrganon and Co·Phase 4·NCT00652444·120 enrolled

Cognitive Decline1 trial

Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients

Completed·RRadboud University Medical Center·Phase 4·NCT00449410·35 enrolled

Platelet Aggregation1 trial

Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation

Completed·ZZiv Hospital·Phase 4·NCT00466401·20 enrolled

Monoclonal1 trial

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

Completed· Amgen logo

Amgen·Phase 3·NCT01763866·2,067 enrolled

ART1 trial

Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects

Completed·UUniversity of California, San Diego·Phase 4·NCT00376246·28 enrolled

Monotherapy1 trial

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Unknown status·OOspedale di Circolo - Fondazione Macchi·Phase 4·NCT00843661·60 enrolled

Lip1 trial

Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01723735·79 enrolled

Inflammation1 trial

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

Completed·FFederal University of São Paulo·N/A·NCT01103648·50 enrolled

Renal Protection1 trial

Study of Heart and Renal Protection

Completed·UUniversity of Oxford·Phase 4·NCT00125593·9,438 enrolled

Bone Health1 trial

Statin and Bone Health

Unknown status·TThe University of Hong Kong·Phase 4·NCT05613400·240 enrolled

Alcoholic Fatty Liver Disease1 trial

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）

Completed· Haisco Pharmaceutical Group Co., Ltd. logo

Haisco Pharmaceutical Group Co., Ltd.·Phase 2·NCT05795517·210 enrolled

Hepatitis C1 trial

Transplantation Using Hepatitis C Positive Donors, A Safety Trial

Unknown status·JJordan Feld·Phase 3·NCT04017338·40 enrolled

Prostate Cancer1 trial

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Recruiting·—·Phase 2·NCT06437574·140 enrolled

Lipidemia1 trial

Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

Completed·OOrganon and Co·Phase 3·NCT00651560·167 enrolled

High Risk1 trial

Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients

Unknown status·PPoliclinico Casilino ASL RMB·Phase 4·NCT04397653·50 enrolled

Platelet Function1 trial

Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment

Completed·KKarolinska Institutet·Phase 4·NCT01035320·39 enrolled

Acute Myocardial Infarction1 trial

Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction.

Completed·OOdense University Hospital·Phase 4·NCT01385631·87 enrolled

Homozygous Familial Hypercholesterolemia1 trial

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510715·18 enrolled

Unspecified4 trials

Ezetrol Post-Marketing Study

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00753883·40 enrolled

Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Completed·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT05681247·59 enrolled

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Completed·NNewAmsterdam Pharma·Phase 2·NCT05266586·119 enrolled

Show 1 more trial

Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Unknown status·CCao Yu·Phase 1·NCT04814589·96 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 25, 2002

ZETIA

NDA NDA021445

Jul 23, 2004

ZETIA

NDA NDA021445

Jul 23, 2004

ZETIA

NDA NDA021445

Jul 23, 2004

ZETIA

NDA NDA021445

Sep 22, 2004

ZETIA

NDA NDA021445

Mar 2, 2005

ZETIA

NDA NDA021445

Mar 22, 2005

ZETIA

NDA NDA021445

Jan 19, 2006

ZETIA

NDA NDA021445

Mar 16, 2006

ZETIA

NDA NDA021445

Mar 16, 2006

ZETIA

NDA NDA021445

May 23, 2006

ZETIA

NDA NDA021445

Nov 2, 2006

ZETIA

NDA NDA021445

Dec 10, 2007

ZETIA

NDA NDA021445

Dec 10, 2007

ZETIA

NDA NDA021445

Feb 7, 2008

ZETIA

NDA NDA021445

Jun 5, 2008

ZETIA

NDA NDA021445

Jun 5, 2008

ZETIA

NDA NDA021445

Jan 27, 2009

ZETIA

NDA NDA021445

Jul 21, 2009

ZETIA

NDA NDA021445

Jul 21, 2009

ZETIA

NDA NDA021445

Jul 29, 2011

ZETIA

NDA NDA021445

Jan 24, 2012

ZETIA

NDA NDA021445

Jan 11, 2013

ZETIA

NDA NDA021445

Feb 15, 2013

ZETIA

NDA NDA021445

Jun 4, 2013

ZETIA

NDA NDA021445

Sep 30, 2014

ZETIA

NDA NDA021445

Oct 3, 2019

ZETIA

NDA NDA021445

Jul 20, 2023

ZETIA

NDA NDA021445

Feb 21, 2024

ZETIA

NDA NDA021445

Sources

References

[1]
ClinicalTrials.gov — 212 trial records for Ezetimibe. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zetia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ezetimibe compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ezetimibe. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021445). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zetia. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Niemann-Pick C1-Like Protein 1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Patent Landscape[6]

Patent #Expires

7612058Oct 30, 2025

7612058*PEDApr 30, 2026

Zetia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q2 2028

Trials by Indication[1]

Hypercholesterolemia41 trials

Cholesterol15 trials

Statin10 trials

Atorvastatin9 trials

Heart Disease7 trials

Type 2 Diabetes6 trials

Antibody5 trials

Efficacy and Safety5 trials

Effectiveness4 trials

Chronic Hepatitis4 trials

Safety and Efficacy3 trials

Metabolic Syndrome3 trials

Myocardial Infarction3 trials

Cardiovascular Disease3 trials

Dyslipidemia3 trials

Acute Coronary Syndrome3 trials

Interaction3 trials

Efficacy3 trials

Drug Interactions3 trials

Familial Hypercholesterolemia3 trials

Peripheral Arterial Disease2 trials

Hyperlipidemia2 trials

High Cardiovascular Risk2 trials

Atherosclerosis2 trials

Treatment2 trials

Drug Therapy2 trials

Combination Therapy2 trials

Sitosterolemia2 trials

Randomized2 trials

Non-Alcoholic Steatohepatitis2 trials

Statins2 trials

LDL-cholesterol2 trials

TIA2 trials

Systemic Inflammation1 trial

Tics1 trial

Metabolic Disease1 trial

Adolescent1 trial

Aortic Stenosis1 trial

Left Ventricular Hypertrophy1 trial

Newly Diagnosed1 trial

Coronary Artery Disease1 trial

Rigidity1 trial

Diabetes1 trial

TED1 trial

Kidney Transplant1 trial

Function1 trial

Prospective1 trial

Cardiovascular1 trial

Pilot Study1 trial

Double-blind1 trial

Cognitive Decline1 trial

Platelet Aggregation1 trial

Monoclonal1 trial

ART1 trial

Monotherapy1 trial

Lip1 trial

Inflammation1 trial

Renal Protection1 trial

Bone Health1 trial

Alcoholic Fatty Liver Disease1 trial

Hepatitis C1 trial

Prostate Cancer1 trial

Lipidemia1 trial

High Risk1 trial

Platelet Function1 trial

Acute Myocardial Infarction1 trial

Homozygous Familial Hypercholesterolemia1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts