CRESTOR (rosuvastatin calcium) · AstraZeneca
Crestor (rosuvastatin calcium) is an HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia, hypertriglyceridemia, or primary dysbetalipoproteinemia,
How CRESTOR Works
Crestor works by blocking HMG-CoA reductase, the primary enzyme the body uses to produce cholesterol. By inhibiting this enzyme, the drug stops the conversion of HMG-CoA into mevalonate, which is a necessary precursor for making cholesterol.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2003-08-12
- Routes
- ORAL
- Dosage Forms
- TABLET
CRESTOR Approval History
What CRESTOR Treats
6 indicationsCRESTOR is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperlipidemia
- Atherosclerosis
- Heterozygous Familial Hypercholesterolemia
- Homozygous Familial Hypercholesterolemia
- Primary Dysbetalipoproteinemia
- Hypertriglyceridemia
CRESTOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03113994 RoBaCO | 2016-350642 | Ph 2 | terminated | Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk |
| NCT04319627 SAVER | SAVER Trial | Ph 3 | recruiting | Statins for Venous Event Reduction in Patients With Venous Thromboembolism |
| NCT04602754 | EMS1019 - Berlim 25/20 | Ph 3 | recruiting | Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia. |
| NCT06081166 | TA-8995-11 | Ph 1 | completed | A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin |
| NCT05828303 | CA127-1027 | Ph 1 | withdrawn | A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors |
| NCT02289430 NVP-1205 | NVP-1205-02 | Ph 1 | completed | to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers |
| NCT01078675 results posted | D3561C00002 | Ph 3 | completed | An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia |
| NCT00766025 | D3560C00059 Rosuvastatin Calcium | Ph 1 | completed | Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin |
| NCT04621669 | SHR3680-I-DDI-03 | Ph 1 | completed | Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CRESTOR FDA Label Details
Indications & Usage
FDA Label (PDF)CRESTOR is 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 at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with hypercholesterolemia. ∘ and slow the progression of atherosclerosis in adults. ∘ in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ∘ in adults and pediatric patients aged 7 years and older with h...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment