Inhibits HMG-CoA reductase, an enzyme in cholesterol synthesis. Source
Adults with hypercholesterolemia
Study contextSelected approval record (2003-08-12): FDA approved rosuvastatin as Crestor for lipid indications.
Status sourceStatus & indicationsLDL-C: 63% reduction within arm · 6 weeks
Dose-response trial · regulatory-label · 40 mg daily · Adjusted mean change from baseline.
Evidence & limitationsLabel risks: muscle injury, liver enzyme elevations and increased glucose; muscle risk is greater at 40 mg.
Safety contextA next milestone is not summarized for this therapy.
Milestone detailsStudy results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
LDL-C: 63% reduction within arm · 6 weeks
40 mg daily
Adults with hypercholesterolemia
Adjusted mean change from baseline.
Label risks: muscle injury, liver enzyme elevations and increased glucose; muscle risk is greater at 40 mg.
Limitations: Small displayed arm. These dose-response data differ from larger trials; do not treat the value as a universal expected response.
Status in this atlas: Selected approval record (2003-08-12): FDA approved rosuvastatin as Crestor for lipid indications. Status source
Inhibits HMG-CoA reductase, an enzyme in cholesterol synthesis.
Mechanism sourceMechanism & side effects: Statins
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Chemical structure of the rosuvastatin parent molecule.
Shown: Rosuvastatin free acid; calcium counterion omitted.
Crestor contains rosuvastatin calcium. The drawing shows the parent molecule rather than the full salt. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
PubChem CID 446157Rosuvastatin · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
An early placebo-controlled program reported dose-dependent LDL-C reductions with investigational rosuvastatin.
Olsson — rosuvastatin phase 2 resultsA six-week randomized trial compared rosuvastatin and atorvastatin across dose ranges, measuring LDL-C, ApoB and other lipid changes.
Schneck et al. — dose-response studyFDA approved rosuvastatin as Crestor for lipid indications.
FDA — original Crestor approval letterRosuvastatin reduced vascular events in people without clinical cardiovascular disease who had elevated high-sensitivity C-reactive protein. Physician-reported diabetes was more frequent.
JUPITER — NEJMRosuvastatin reduced cardiovascular events in an ethnically diverse population at intermediate risk without established cardiovascular disease.
HOPE-3 — NEJMSelected sources checked Sep 14, 2026. This is not an exhaustive history.
