LESCOL XL (fluvastatin sodium)
Lescol XL is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. It is also indicated for adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) who require an 80 mg daily dose of fluvastatin. Additionally, in adults with clinically evident coronary heart disease, Lescol XL is used to slow the progression of coronary atherosclerosis and reduce the risk of undergoing coronary revascularization procedures.
How LESCOL XL Works
Fluvastatin is a competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme involved in endogenous cholesterol synthesis. By inhibiting this enzyme, the drug prevents the conversion of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a critical precursor of cholesterol. This reduction in hepatic cholesterol synthesis leads to an upregulation of LDL receptors and a subsequent increase in the catabolism of circulating LDL cholesterol.
Details
- Status
- Prescription
- First Approved
- 2000-10-06
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
LESCOL XL Approval History
What LESCOL XL Treats
4 indicationsLESCOL XL is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Heart Disease
- Coronary Atherosclerosis
- Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
LESCOL XL 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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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01551173 results posted | CXUO320BCN01 | Ph 4 | completed | Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
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.
LESCOL XL FDA Label Details
Indications & Usage
FDA Label (PDF)LESCOL XL is indicated for the treatment of Coronary Heart Disease; Coronary Atherosclerosis; Hyperlipidemia; Heterozygous Familial Hypercholesterolemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.