Rosuvastatin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Rosuvastatin appears in the FDA drug-label database. Marketed as Rosuvastatin.
- 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
Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of major adverse cardiovascular (CV) events (CV deat…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| 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 |
| CGMP Deviations — Glenmark Pharmaceuticals Inc., USA | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-03-13 |
| 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 |
| Out of specification for dissolution. — AvKARE | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-12-31 |
| 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 |
Phase breakdown
Conditions being studied
Recruiting trials involving Rosuvastatin
- A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Effect of Statins on Crohn's Disease
- Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
- Statins to Prevent Cancer Associated Blood Clots
Common questions
Is Rosuvastatin FDA-approved?
Yes, marketed as Rosuvastatin.
How many recruiting trials involve Rosuvastatin?
5 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.