Data updated: May 26, 2026
ROSZET (ezetimibe)
Metabolic
Approved 2021-03-23
2
Indications
--
Phase 3 Trials
5
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2021-03-23
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
ROSZET Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2021 to 2024 · 1 indication expansions
What ROSZET Treats
2 FDA approvalsOriginally approved for its first indication in 2021 . Covers 2 distinct patient populations.
- Other (2)
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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
Full development history with FDA approval milestones
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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.
ROSZET FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
18 international docs across 11 countries
ROSZET Patents & Exclusivity
Latest Patent: May 2033
Patents (2 active)
US10376470
Expires May 1, 2033
US9763885
Expires May 1, 2033
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.