EligibleTrials

Rosuvastatin: clinical trials recruiting now

5
Recruiting trials
15
Conditions studied
11
US states with sites
7
Countries

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)ClassificationStatusInitiated
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

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 1 1 Phase 2 1 Phase 4 1 Not applicable 1

Conditions being studied

ConditionTrials
Cancer1
Cardiovascular Events1
Cirrhosis1
Cirrhosis Advanced1
Cirrhosis Alcoholic1
Cirrhosis Due to Hepatitis B1
Cirrhosis Due to Hepatitis C1
Cirrhosis Early1
Cirrhosis Infectious1
Cirrhosis, Liver1
Crohn Disease1
Crohn's Ileocolitis1
Crohn's disease1
Hepatitis B1
High cholesterol1

Recruiting trials involving Rosuvastatin

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.

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