Atorvastatin clinical trials
Atorvastatin is named as an intervention in 47 current clinical trials in our China, Italy, Egypt, Taiwan, Australia, Germany, Denmark, Norway, South Korea, USA, Spain, Sweden, Switzerland, Netherlands, Belgium, Austria, France, Czechia, Poland, Turkey, Canada and Singapore registers. 24 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is The First Affiliated Hospital with Nanjing Medical University (3). The most-studied condition is Ischemic Stroke. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Atorvastatin is approved
All regulators →Of the three regulators tracked here, the first to approve Atorvastatin was the US, on 17 Dec 1996. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of familial cerebral cavernous malformations (11 Nov 2022, positive)
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.
Atorvastatin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Atorvastatin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 7 Jun 2037 (US 11654106).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Atorvastatin
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 Atorvastatin works
All drug targets →- HMG-CoA reductase inhibitor InhibitorTarget: HMGCR 3-hydroxy-3-methylglutaryl-CoA reductase✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- COVID-19Phase 3
- Combined hyperlipidemiaPhase 3
- Graves ophthalmopathyPhase 3
- HIV infectious diseasePhase 3
- Insulin resistancePhase 3
- Kawasaki diseasePhase 3
- Acute coronary syndromePhase 3
- Aortic stenosisPhase 3
- AtherosclerosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1487, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2949, 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 Atorvastatin
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Atorvastatin. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Statins for the prevention of cardiovascular events NICE TA94 | Recommended | 25 Jan 2006 | 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 Atorvastatin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 69 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 Atorvastatin
- ATC code
- C10AA05
- ChEMBL
- CHEMBL1487
- DrugBank
- DB01076
- PubChem CID
- 60823
- CAS number
- 134523-00-5
- FDA UNII
- A0JWA85V8F
- Wikidata
- Q668093
- Wikipedia
- Atorvastatin
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 Atorvastatin
47 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.
Atorvastatin in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Atorvastatin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Atorvastatin 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)
69 single-substance products containing Atorvastatin on the HPRA medicines list.
- Atorvas 10 mg film-coated tabletsRowex Limited, · PA0711/180/001 · Marketed
- Atorvas 20 mg film-coated tabletsRowex Limited, · PA0711/180/002 · Marketed
- Atorvas 40 mg film-coated tabletsRowex Limited, · PA0711/180/003 · Marketed
- Atorvas 80 mg film-coated tabletsRowex Limited, · PA0711/180/004 · Marketed
- Atorvastatin 10 mg Film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/195/001 · Marketed
Supply shortages
No entry for Atorvastatin in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- Atorvastatin CalciumFDA · 9 Jan 2017 · Generic (ANDA) · Invagen Pharms
Conditions studied with Atorvastatin
72 conditionsAll 72 conditions
| Condition (as registered) | Trials |
|---|---|
| Ischemic Stroke | 6 |
| Moyamoya Disease | 2 |
| Postoperative Atrial Fibrillation | 2 |
| Mixed Dyslipidemia | 2 |
| Graves Ophthalmopathy | 2 |
| Long COVID | 1 |
| Healthy Participants | 1 |
| Overweight | 1 |
| Obesity | 1 |
| Schizophrenia | 1 |
| Moyomoya Disease | 1 |
| Glioblastoma, IDH-wildtype | 1 |
| Cerebrovascular Event | 1 |
| Stent Stenosis | 1 |
| Hemorrhagic Stroke | 1 |
| Advanced Renal Cell Carcinoma (RCC) | 1 |
| PTC | 1 |
| Atorvastatin | 1 |
| Targeted Therapy Combined With Immunotherapy | 1 |
| Plaque, Atherosclerotic | 1 |
| Prediabetic State (IGT) | 1 |
| Kawasaki Disease | 1 |
| Coronary Artery Abnormalities | 1 |
| Carotid Atherosclerotic Plaque | 1 |
| Lung Surgery | 1 |
| Large-Artery Atherosclerosis (Embolus/Thrombosis) | 1 |
| Coronary Atherosclerosis | 1 |
| Hypercholesterolemia | 1 |
| Covert Brain Infarction | 1 |
| Primary Hypercholesterolemiia | 1 |
| Prostate Cancer | 1 |
| Arrhythmogenic Cardiomyopathy | 1 |
| Graves' Orbitopathy | 1 |
| TIA | 1 |
| Atherosclerosis | 1 |
| Melanoma | 1 |
| Immune-related Adverse Event | 1 |
| Graves Disease | 1 |
| Graves Disease (Basedow's Disease) | 1 |
| Graves Orbitopathy | 1 |
| Breast Cancer Female | 1 |
| Estrogen Receptor Positive Tumor | 1 |
| Copd | 1 |
| COPD Exacerbation | 1 |
| Smoking | 1 |
| Gene Expression | 1 |
| Chronic Migraine | 1 |
| Episodic Migraine | 1 |
| Carotid Stenosis | 1 |
| Metastatic Prostate Cancer | 1 |
| Atherosclerotic Cardiovascular Disease With Dyslipidemia | 1 |
| Acute Coronary Syndromes (ACS) | 1 |
| Dyslipidemias | 1 |
| Atherosclerotic Cardiovascular Disease | 1 |
| HepatoCellular Carcinoma | 1 |
| Autosomal Dominant Polycystic Kidney Disease | 1 |
| Chronic Kidney Diseases | 1 |
| Hypercholesteremia | 1 |
| Thyroid Eye Disease, TED | 1 |
| Metabolite | 1 |
| Neurocognitive Impairment, Mild | 1 |
| Dementia, Mixed | 1 |
| Dementia, Vascular | 1 |
| Dementia of Alzheimer Type | 1 |
| Cognitive Decline | 1 |
| Independent Living | 1 |
| Disability Free Survival | 1 |
| Elderly | 1 |
| Healthy | 1 |
| Healthy Adults | 1 |
| Non-alcoholic Fatty Liver Disease NAFLD | 1 |
| Non-alcoholic Steatohepatitis NASH | 1 |
Sponsors
lead sponsor per trial+ 25 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. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Atorvastatin trials
How many clinical trials are testing Atorvastatin?
47 current trials in our China, Italy, Egypt, Taiwan, Australia, Germany, Denmark, Norway, South Korea, USA, Spain, Sweden, Switzerland, Netherlands, Belgium, Austria, France, Czechia, Poland, Turkey, Canada and Singapore registers name Atorvastatin as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Atorvastatin trials recruiting patients?
Yes. 24 of the 47 trials are recruiting: 8 with sites in China, 2 with sites in Italy, 2 with sites in Egypt, 2 with sites in Taiwan, 1 with sites in Germany, 3 with sites in Denmark, 3 with sites in Norway, 2 with sites in South Korea, 1 with sites in Sweden, 2 with sites in Switzerland, 1 with sites in Netherlands, 1 with sites in France, 1 with sites in Czechia, 1 with sites in Canada and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Atorvastatin clinical trials?
The First Affiliated Hospital with Nanjing Medical University (3), Aarhus University Hospital (2), St. Olavs Hospital (2) and Yonsei University (2), among 40 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Atorvastatin licensed in Ireland?
Yes. The HPRA medicines list includes 69 single-substance products containing Atorvastatin, for example Atorvas 10 mg film-coated tablets (Rowex Limited,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Atorvastatin shortage?
Not in the lists we track: Atorvastatin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Atorvastatin 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 Atorvastatin 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 Atorvastatin (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.