How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers LDL cholesterol in hyperlipidaemia

79%High confidence

Uncertainty ±4%Evidence coverage: SubstantialUpdated 1 December 2025

Confidence is moderated by well-powered no-effect evidence, despite broad trial support.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Ezetimibe

Aliases & brands

LiptruzetNexlizetRoszetVytorinZetiaEzetimibe-RosuvastatinEzetimibe-SimvastatinEzetimibaézétimibeEzetimibum

RxNorm CUI

341248

ChEMBL ID

CHEMBL1138

ATC codes

C10AX09

UNII

EOR26LQQ24

Primary mechanism

Niemann-Pick C1-like protein 1 inhibitor

Regulatory jurisdictions

fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

NPC1-like intracellular cholesterol transporter 1

NPC1L1 · Q9UHC9

INHIBITORNiemann-Pick C1-like protein 1 inhibitor

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2017-12-21

Latest approval

2018-05-21

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 5 events

2024-08-15Label change

Label change: EZETIMIBE (ANDA209234)

Evidence ↗

2024-06-17Label change

Label change: EZETIMIBE (ANDA209234)

Evidence ↗

2022-12-16Label change

Label change: EZETIMIBE (ANDA209234)

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

171 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

171

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

129

Late-stage (III+)

135

Completed

Discontinued

PHASE DISTRIBUTIONn = 171

Early Phase 11Phase 119Phase 222Phase 2 / 31Phase 361Phase 454Phase N / A13

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2×2 Randomized Controlled Trial

Not yet recruitingPH IVPeking Union Medical College Hospitaln=4202029

CHORD1 - CHOlesterol Lowering and Residual Risk in Diabetes, Type 1

RecruitingPH IVNYU Langone Healthn=1252027

A Multicenter Study to Evaluate Efficacy and Safety

Active, not recruitingPH IVJW Pharmaceuticaln=882026

Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial

Not yet recruitingPH IVPunjab Institute of Cardologyn=1202026

The Effect of Simvastatin on Bone Density in Postmenopausal Women With Type 2 Diabetes: a Double-blind, Randomized Active-comparator (Ezetimibe) Controlled Clinical Trial

Unknown statusPH IVThe University of Hong Kongn=2402025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study To Assess The Bioequivalence of A Test Fixed Dose Combination Product Versus The Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582026

A Randomized, Single-Center, Open-Label, Single-Dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 MG, Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582026

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study to Assess the Bioequivalence of a Test Fixed Dose Combination Product Versus the Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg and Rosuvastatin 20 mg in Healthy Participants

CompletedPH IDaiichi Sankyon=582025

A Randomized, Single-Center, Open-Label, Single-dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 mg, Ezetimibe 10 mg And Rosuvastatin 20 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582025

A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.

CompletedPH IAstraZenecan=812025

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

CompletedPH IIIMerck Sharp & Dohme LLCn=3012025

Research activity

7 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20112025

Most influential

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

The New England journal of medicine · 2015 · 3,026 cites

European heart journal · 2017 · 2,459 cites

Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease.

The New England journal of medicine · 2022 · 405 cites

Efficacy and safety of ezetimibe monotherapy in children with heterozygous familial or nonfamilial hypercholesterolemia.

The Journal of pediatrics · 2015 · 47 cites

Combined effects of ezetimibe and phytosterols on cholesterol metabolism: a randomized, controlled feeding study in humans.

Circulation · 2011 · 46 cites

Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial.

Lancet (London, England) · 2025 · 31 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Atherosclerosis2 Cardiovascular Diseases2

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Olpasiran

Studied across 3 of the same disease areas as Ezetimibe in the shared literature.

3 shared diseases1 shared paper

Triglycerides

Studied across 3 of the same disease areas as Ezetimibe in the shared literature.

3 shared diseases1 shared paper

Simvastatin

Studied across 2 of the same disease areas as Ezetimibe in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.