Atorvastatin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Atorvastatin appears in the FDA drug-label database. Marketed as Atorvastatin Calcium.
- Drug class
- HMG-CoA Reductase Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (as stated on the FDA label)
FDA-approved use
Atorvastatin calcium tablets is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. — Ranbaxy Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-11-09 |
| CGMP Deviations: recalling drug products following an FDA inspection. — Accord Healthcare, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-02-07 |
| Failed Dissolution Specifications — Ascend Laboratories, LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-19 |
| Subpotent drug — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2015-05-06 |
| Failed Impurities/Degradation Specifications: Out of Specification results for related substance. — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2022-03-16 |
Phase breakdown
Conditions being studied
Recruiting trials involving Atorvastatin
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
- Measuring Oncological Value of Exercise and Statin
- Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
- Novel Approaches for Improving Vascular Function in Veterans With HFpEF
- Perioperative Statins to Prevent AFib After Lung Surgery
- Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Common questions
Is Atorvastatin FDA-approved?
Yes, marketed as Atorvastatin Calcium.
How many recruiting trials involve Atorvastatin?
7 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.