PRAVASTATIN SODIUM
Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. It is also indicated for the treatment of hypertriglyceridemia and primary dysbetalipoproteinemia. In clinical practice, it is used for the primary prevention of cardiovascular events (reducing risk of MI, revascularization, and cardiovascular mortality) in hypercholesterolemic patients without clinically evident coronary heart disease (CHD), and for secondary prevention in patients with established CHD to reduce the risk of total mortality, stroke, and the progression of coronary atherosclerosis. Additionally, it is indicated for pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.
How PRAVASTATIN SODIUM Works
Pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is the early and rate-limiting step in the biosynthetic pathway of cholesterol. By inhibiting this enzyme, pravastatin reduces hepatic cholesterol synthesis and increases the expression of LDL receptors on hepatocyte surfaces, enhancing the uptake and catabolism of LDL-C. It also results in a reduction of VLDL and TG levels and an increase in HDL-C.
Details
- Status
- Discontinued
- First Approved
- 2006-04-24
- Routes
- ORAL
- Dosage Forms
- TABLET
PRAVASTATIN SODIUM Approval History
What PRAVASTATIN SODIUM Treats
13 FDA approvalsOriginally approved for its first indication in 2006 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Apr 2006)
- • Approved indication (Oct 2006)
- • Approved indication (May 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Jan 2008)
- • Approved indication (Feb 2008)
- • Approved indication (Apr 2008)
- • Approved indication (May 2010)
- • Approved indication (Mar 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Apr 2018)Letter
- • Approved indication (Nov 2018)
PRAVASTATIN SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00840177 results posted | S0919 S0919, U10CA032102 | Ph 2 | completed | S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia |
| NCT01075555 | CDR0000666232 FFCD-PRODIGE-11, FFCD-0803 | Ph 3 | completed | Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis |
| NCT01342887 results posted | 2409.00 NCI-2011-00657 | Ph 1, Ph 2 | terminated | Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT01515813 | ACTG A5292 1U01AI068636 | Ph 2 | withdrawn | Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation |
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.
PRAVASTATIN SODIUM FDA Label Details
Indications & Usage
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin Sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic...
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PRAVACHOL
Full clinical data, patents, trials, and competitive landscape for pravastatin sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.