Active Ingredient History
Pitavastatin is a new synthetic 3-hydroxy-3-methyl glutaryl coenzyme A reductase (HMG-CoA reductase) inhibitor, which was developed, and has been available in Japan since July 2003. Metabolism of pitavastatin by the cytochrome P450 (CYP) system is minimal, principally through CYP 2C9, with little involvement of the CYP 3A4 isoenzyme, potentially reducing the risk of drug-drug interactions between pitavastatin and other drugs known to inhibit CYP enzymes. To date, human and animal studies have shown pitavastatin to be potentially as effective in lowering LDL-cholesterol levels as rosuvastatin. Pitavastatin under the trade name Livalo is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins. Common statin-related side effects (headaches, stomach upset, abnormal liver function tests and muscle cramps) were similar to other statins. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Angina Pectoris (Phase 4)
Atherosclerosis (Phase 4)
Breast Neoplasms (Phase 2/Phase 3)
Cardiovascular Diseases (Phase 4)
Coronary Artery Disease (Phase 4)
Coronary Disease (Phase 4)
Diabetes Mellitus (Phase 4)
Diabetes Mellitus, Type 2 (Phase 3)
Dyslipidemias (Phase 4)
Glioblastoma (Early Phase 1)
Glucose Intolerance (Phase 4)
Glucose Metabolism Disorders (Phase 4)
Healthy Volunteers (Phase 4)
Heart Disease Risk Factors (Phase 4)
Heart Failure (Phase 4)
HIV (Phase 4)
HIV Infections (Phase 4)
Hypercholesterolemia (Phase 4)
Hyperlipidemias (Phase 4)
Hypertension (Phase 4)
Immunosuppression Therapy (Phase 4)
Inflammation (Phase 4)
Influenza, Human (Phase 1)
Kidney Diseases (Phase 4)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 1)
Leukemia, Myeloid, Acute (Phase 1)
Liver Transplantation (Phase 4)
Metabolic Syndrome (Phase 4)
Myocardial Infarction (Phase 4)
Neointima (Phase 4)
Obesity (Phase 4)
Oxidative Stress (Phase 4)
Percutaneous Coronary Intervention (Phase 4)
Prediabetic State (Phase 4)
Renal Insufficiency (Phase 1)
Renal Insufficiency, Chronic (Phase 4)
| Trial | Phase | Start Date | Organizations | Indications |
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