Ezetimibe clinical trials
Ezetimibe is named as an intervention in 16 current clinical trials in our South Korea, China, Germany, Spain, Italy, Taiwan, Belgium, Austria, Portugal and Egypt registers. 8 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Yun Dai Chen (1). The most-studied condition is Acute Myocardial Infarction.
Where Ezetimibe is approved
All regulators →Of the three regulators tracked here, the first to approve Ezetimibe was the US, on 25 Oct 2002. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Ezetimibe
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ezetimibe works
All drug targets →- Niemann-Pick C1-like protein 1 inhibitor InhibitorTarget: NPC1L1 NPC1 like intracellular cholesterol transporter 1✓ In ChEMBL and the Guide to Pharmacology
- Combined hyperlipidemiaPhase 3
- Increased body weightPhase 3
- Acute coronary syndromePhase 3
- Coronary artery disorderPhase 3
- Coronary atherosclerosisPhase 3
- Diabetes mellitusPhase 3
- Diabetic kidney diseasePhase 3
- Essential hypertensionPhase 3
- Homozygous familial hypercholesterolemiaPhase 3
- Hypertensive disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1138, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6816, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Ezetimibe
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Ezetimibe. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia NICE TA385 | Recommended | 24 Feb 2016 | Current |
| Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia NICE TA132 | Recommended | 28 Nov 2007 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Ezetimibe
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ezetimibe
- ATC code
- C10AX09
- ChEMBL
- CHEMBL1138
- DrugBank
- DB00973
- PubChem CID
- 150311
- CAS number
- 163222-33-1
- FDA UNII
- EOR26LQQ24
- Wikidata
- Q417997
- Wikipedia
- Ezetimibe
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ezetimibe
16 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ezetimibe across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
7 single-substance products containing Ezetimibe on the HPRA medicines list.
- Ezetimibe 10 mg tabletsViatris Limited · PA23266/050/001 · Marketed
- Ezetimibe 10 mg tabletsAccord Healthcare Ireland Ltd. · PA2315/088/001 · Marketed
- Ezetimibe Krka 10 mg tabletsKRKA, d.d., Novo mesto · PA1347/066/001 · Marketed
- Ezetimibe Rowa 10 mg tabletsRowa Pharmaceuticals Limited, · PA0074/074/001 · Marketed
- Ezetrol 10 mg tabletsOrganon Pharma (Ireland) Limited · PA23198/023/001 · Marketed
Supply shortages
- EZETIMIB/SIMVA BASICS 10 mg/80 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
- EZETIMIB/SIMVA BASICS 10 mg/40 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
- EZETIMIB/SIMVA BASICS 10 mg/40 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
- EZETIMIB/SIMVA BASICS 10 mg/10 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
- EZETIMIB/SIMVA BASICS 10 mg/20 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
- EZETIMIB/SIMVA BASICS 10 mg/20 mg TablettenGermany (BfArM) · Other reason · 1 Sep 2025 to 30 Nov 2026
+ 2 more German shortage notices.
Conditions studied with Ezetimibe
27 conditionsAll 27 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Myocardial Infarction | 2 |
| Mixed Dyslipidemia | 2 |
| Hypercholesterolemia | 2 |
| Ischemic Stroke | 2 |
| Intracranial Arteriosclerosis | 1 |
| Cognitive Impairment | 1 |
| Coronary Atherosclerosis | 1 |
| Primary Hypercholesterolemiia | 1 |
| Atherosclerotic Cardiovascular Disease (ASCVD) | 1 |
| Cardiovascular Risk | 1 |
| LDL Cholesterol | 1 |
| Dyslipidemia Associated With Type II Diabetes Mellitus | 1 |
| Small Vessel Cerebrovascular Disease | 1 |
| Cholesterol, LDL | 1 |
| Secondary Prevention | 1 |
| Atherosclerotic Cardiovascular Disease With Dyslipidemia | 1 |
| Pre Diabetes | 1 |
| ASCVD | 1 |
| Acute Coronary Syndromes (ACS) | 1 |
| Myocardial Infarction | 1 |
| Statin Adverse Reaction | 1 |
| HMG-CoA Reductase Inhibitor Toxicity | 1 |
| Coronary Artery Disease | 1 |
| Acute Coronary Syndromes | 1 |
| Dyslipidemia | 1 |
| Hypercholesteremia | 1 |
| Dyslipidemias | 1 |
Sponsors
lead sponsor per trial+ 1 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Ezetimibe trials
How many clinical trials are testing Ezetimibe?
16 current trials in our South Korea, China, Germany, Spain, Italy, Taiwan, Belgium, Austria, Portugal and Egypt registers name Ezetimibe as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ezetimibe trials recruiting patients?
Yes. 8 of the 16 trials are recruiting: 4 with sites in South Korea, 2 with sites in Taiwan, 1 with sites in Portugal and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ezetimibe clinical trials?
Yun Dai Chen (1), Peking Union Medical College Hospital (1), Daiichi Sankyo (1) and Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (1), among 16 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Ezetimibe licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Ezetimibe, for example Ezetimibe 10 mg tablets (Viatris Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ezetimibe shortage?
The registers we track list 8 entries for Ezetimibe: 8 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ezetimibe works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ezetimibe works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ezetimibe (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.