PITAVASTATIN CALCIUM · ORIENT PHARMA CO LTD
Pitavastatin calcium is a cholesterol-lowering medication used alongside dietary changes to help patients manage high cholesterol levels. It treats adults with primary hyperlipidemia and is also used for both adults and children eight years and older who have heterozygous familial hypercholesterolemia. By lowering low-density lipoprotein cholesterol (LDL-C), this medication helps improve the lipid profile in these specific patient populations.
How PITAVASTATIN CALCIUM Works
This medication works by inhibiting HMG-CoA reductase, the enzyme responsible for a key step in the body's cholesterol production. This action triggers the liver to increase its expression of LDL receptors, which pulls more cholesterol out of the bloodstream. Consequently, the drug reduces levels of total cholesterol and very low density lipoproteins.
Details
- Status
- Prescription
- First Approved
- 2009-08-03
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PITAVASTATIN CALCIUM Approval History
What PITAVASTATIN CALCIUM Treats
2 indicationsPITAVASTATIN CALCIUM is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
PITAVASTATIN CALCIUM 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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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.
PITAVASTATIN CALCIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
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Full clinical data, patents, trials, and competitive landscape for pitavastatin calcium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.