LIVALO (pitavastatin calcium)
Livalo is a cholesterol-lowering medication used alongside dietary changes to help patients manage high levels of low-density lipoprotein (LDL-C). It treats adults with primary hyperlipidemia as well as both adults and children eight years and older who have heterozygous familial hypercholesterolemia. By lowering these lipid levels, the drug helps address chronic cholesterol imbalances in these patient populations.
How LIVALO Works
This medication works by inhibiting HMG-CoA reductase, the enzyme that controls the rate-limiting step in the body's cholesterol production. This process triggers the liver to increase its expression of LDL-receptors, which accelerates the removal of cholesterol from the bloodstream into the liver. This action results in lower plasma total cholesterol and decreased levels of very low density lipoproteins.
Details
- Status
- Prescription
- First Approved
- 2009-08-03
- Routes
- ORAL
- Dosage Forms
- TABLET
LIVALO Approval History
What LIVALO Treats
2 indicationsLIVALO is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
LIVALO 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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3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02670434 | NK-104-CR-3.01US | Ph 3 | withdrawn | Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia |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.
LIVALO FDA Label Details
Indications & Usage
FDA Label (PDF)LIVALO is indicated for the treatment of Primary 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.