Data updated: May 26, 2026
EZETIMIBE AND SIMVASTATIN (ezetimibe)
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic
Approved 2017-04-26
This combination medication helps patients with high cholesterol levels when diet and lifestyle changes alone are not sufficient. It treats primary hyperlipidemia, including both familial and non-familial types, as well as mixed hyperlipidemia. Doctors also use it for patients with homozygous familial hypercholesterolemia alongside other lipid-lowering therapies to help reduce total and LDL cholesterol.
Source: FDA Label • GLENMARK PHARMS LTD • HMG-CoA Reductase Inhibitor
How EZETIMIBE AND SIMVASTATIN Works
This therapy works through a dual mechanism that targets both the absorption and production of cholesterol. Ezetimibe blocks the NPC1L1 transporter in the small intestine to prevent cholesterol absorption, while simvastatin inhibits the HMG-CoA reductase enzyme to stop the body from synthesizing its own cholesterol. Together, these actions reduce hepatic cholesterol stores and increase the clearance of cholesterol from the blood.
Source: FDA Label
7
Indications
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Phase 3 Trials
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-04-26
- Routes
- ORAL
- Dosage Forms
- TABLET
EZETIMIBE AND SIMVASTATIN Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
156 FDA actions from 2017 to 2025
Jan 2025 SUPPL
Label · Labeling
Jan 2025 ORIGINAL
Update
Dec 2024 SUPPL
Label · Labeling
Dec 2024 ORIGINAL
Update
Jul 2024 SUPPL
Label
Jul 2024 SUPPL
Label
Jun 2024 SUPPL
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May 2024 SUPPL
Label
Dec 2022 SUPPL
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Feb 2022 SUPPL
Label
Oct 2021 SUPPL
Label
Sep 2021 SUPPL
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Mar 2021 SUPPL
Label
Feb 2021 SUPPL
Label
Dec 2020 ORIGINAL
Update
Jan 2020 SUPPL
Label
Jan 2020 SUPPL
Label
Sep 2019 SUPPL
Label
Sep 2019 SUPPL
Label
Jun 2019 ORIGINAL
Update
Apr 2019 SUPPL
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Apr 2019 SUPPL
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Mar 2019 SUPPL
Label
Dec 2017 ORIGINAL
Update
Nov 2017 ORIGINAL
Update
Apr 2017 ORIGINAL
Update
What EZETIMIBE AND SIMVASTATIN Treats
6 indicationsEZETIMIBE AND SIMVASTATIN is approved for 6 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atherosclerotic Vascular Disease
- Hypercholesterolemia
- Primary Hyperlipidemia
- Mixed Hyperlipidemia
- Homozygous Familial Hypercholesterolemia
- Dyslipidemia
Source: FDA Label
EZETIMIBE AND SIMVASTATIN Competitive Set
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Indication competitors
10
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Drugs Similar to EZETIMIBE AND SIMVASTATIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
ATORVALIQ
ATORVASTATIN CALCIUM
CMP DEV LLC
Shared indications:
Primary HyperlipidemiaHomozygous Familial Hypercholesterolemia
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Clinical Trial Registry
62 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06450366 results posted | 0616-018 MK-0616-018, 2023-504920-25-00 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Enlicitide (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) |
| NCT07474649 | DSE-BMP-0005-CIS-MA 2025-524625-41 | Ph 3 | not yet recruiting | A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events |
| NCT06437574 | STUDY00003290 R01CA280060 | Ph 2 | recruiting | Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer |
| NCT07268625 | DSE-BMP-0003-CIS-MA 2024-519851-27-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin |
| NCT07235189 | DSE-BMP-0001-CIS-MA 2024-519849-29-00 | Ph 1 | completed | A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin |
| NCT07201545 | DSE-BMP-0004-CIS-MA 2024-519852-10-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin |
| NCT07182383 | DSE-BMP-0002-CIS-MA 2024-519850-35-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin |
| NCT06742853 | D7960C00017 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. |
| NCT05763875 V-Mono results posted | CKJX839D12304 | Ph 3 | completed | Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. |
| NCT01611883 results posted | P06541 MK-0653-367 | Ph 4 | completed | A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541) |
| NCT00871351 results posted | P06027 | Ph 4 | completed | Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED) |
| NCT00867165 results posted | P05522 2008-006271-70, MK-0653-170 | Ph 3 | completed | Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522) |
| NCT02748057 results posted | 0653H-833 163314, MK-0653H-833 | Ph 3 | completed | A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833) |
| NCT03510884 results posted | EFC14643 2017-001903-60, U1111-1193-0721 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT03933293 | AK102-202 | Ph 2 | completed | A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH |
| NCT01763866 LAPLACE-2 results posted | 20110115 2012-001363-70 | Ph 3 | completed | LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 |
| NCT01763827 MENDEL-2 results posted | 20110114 | Ph 3 | completed | Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 |
| NCT01375777 MENDEL results posted | 20101154 | Ph 2 | completed | Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels |
| NCT01375764 GAUSS results posted | 20090159 | Ph 2 | completed | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects |
| NCT01516879 DESCARTES results posted | 20110109 | Ph 3 | completed | Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study |
| NCT04643093 | OP-1PC111-301 | Ph 3 | completed | Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
| NCT02476006 results posted | LPS14245 2015-000620-28, U1111-1163-0984 | Ph 3 | completed | Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) |
| NCT01236430 | P07551 | Ph 1 | completed | A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551) |
| NCT01370603 results posted | 0653C-190 | Ph 3 | completed | 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) |
| NCT01370590 results posted | 0653C-185 | Ph 3 | completed | 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) |
| NCT03510715 results posted | EFC14660 2017-002297-39, U1111-1200-2046 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia |
| NCT02634580 GAUSS-4 results posted | 20140234 | Ph 3 | completed | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 |
| NCT01763905 GAUSS-2 results posted | 20110116 2012-001364-30 | Ph 3 | completed | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 |
| NCT01766713 results posted | EZE | Ph 2 | completed | Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis |
| NCT01709513 results posted | R727-CL-1119 | Ph 3 | completed | 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) |
| NCT03001076 results posted | 1002-048 | Ph 3 | completed | 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) |
| NCT03337308 results posted | 1002FDC-053 | Ph 3 | completed | 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 |
| NCT01730053 results posted | R727-CL-1118 | Ph 3 | completed | Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) |
| NCT02682680 GOAL-RCT | GOAL RCT | Ph 4 | completed | Randomized Trial Comparing Colesevelam vs. Ezetimibe |
| NCT02227784 ACCENTUATE results posted | 14502 I1V-MC-EIBH | Ph 3 | terminated | A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol |
| NCT02715726 ODYSSEY EAST results posted | EFC13889 U1111-1150-8859 | Ph 3 | completed | Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia |
| NCT01890967 results posted | 14853 I5S-MC-EFJE | Ph 2 | completed | A Study of LY3015014 in Participants With High Cholesterol |
| NCT02984982 ODYSSEY J-IVUS results posted | ALIROL08069 U1111-1184-8764 | Ph 4 | completed | Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia |
| NCT02890992 ODYSSEY KIDS results posted | DFI14223 2015-003766-85, U1111-1178-4764 | Ph 2 | completed | An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT00965055 results posted | 090948 | Ph 3 | terminated | Ezetimibe in Patients Hypo-responsive to Statins |
| NCT01941836 | 1002-008 | Ph 2 | completed | Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients |
| NCT02055976 results posted | B1481036 | Ph 2 | completed | Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects |
| NCT01984424 GAUSS-3 results posted | 20120332 2013-000935-29 | Ph 3 | completed | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 |
| NCT02260648 results posted | 14501 I1V-JE-EIBG | Ph 3 | terminated | A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia |
| NCT02749994 I-ROSETTE | ID-ROEZ-302 | Ph 3 | completed | 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) |
| NCT02642159 results posted | LPS14354 2015-001934-19, U1111-1172-5262 | Ph 4 | completed | 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) |
| NCT03288038 | SP-RE-003 | Ph 3 | completed | The Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia |
| NCT01723735 | PKD12910 U1111-1131-3203, 2012-003049-13 | Ph 1 | completed | Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects |
| NCT01644188 results posted | EFC11569 U1111-1121-4315, 2011-004130-34 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II) |
| NCT02103049 | UMCL-2014-TX | Ph 4 | completed | The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients |
Showing 50 of 62 trials
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EZETIMIBE AND SIMVASTATIN FDA Label Details
Indications & Usage
EZETIMIBE AND SIMVASTATIN is indicated for the treatment of Atherosclerotic Vascular Disease; Hypercholesterolemia; Primary Hyperlipidemia; Mixed Hyperlipidemia; Homozygous Familial Hypercholesterolemia; Dyslipidemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.