NDAORALTABLET
Approved
Aug 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
LIVALO (pitavastatin calcium) by Kowa Pharmaceuticals is 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase, the enzyme that catalyzes the conversion of hmg-coa to mevalonate, a rate-limiting step in the biosynthetic pathway for cholesterol. First approved in 2009.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIVALO (pitavastatin calcium) is an oral HMG-CoA reductase inhibitor (statin) approved in 2009 for cholesterol management. It reduces LDL cholesterol by inhibiting hepatic cholesterol synthesis and upregulating LDL receptor expression. The drug is indicated for patients requiring LDL-C lowering to reduce cardiovascular risk.
$0.19BPart D
LOE ApproachingProduct approaching loss of exclusivity with $190M in annual spending signals defensive brand positioning and reduced growth opportunities for commercial teams.
Mechanism of Action
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic pathway for cholesterol. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without Diabetes
Started Oct 2022
1,538 enrolled
Hypercholesterolemia
To Evaluate the Safety and PK Characteristics in Healthy Volunteers-Livalozet
Started Jan 2013
52 enrolled
HyperlipidemiaHypertension
Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects
Started Aug 2011
48 enrolled
HyperlipidemiaHypertension
Livalo Acute Myocardial Infarction Study (LAMIS)
Started Jul 2010
1,000 enrolled
Acute Myocardial Infarction
Livalo Acute Myocardial Infarction Study
Started Apr 2007
1,128 enrolled
Acute Myocardial Infarction
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.