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Livalo (PITAVASTATIN)
Livalo (Pitavastatin) is a small molecule HMG-CoA Reductase Inhibitor developed by Kowa Co, targeting the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase. It was FDA approved in 2009 for the treatment of Familial hypercholesterolemia, Hypercholesterolemia, and Mixed hyperlipidemia. Livalo is now off-patent with 8 generic manufacturers available. The drug has a half-life of 4.6 hours and bioavailability of 80%. Key safety considerations include monitoring liver function and muscle damage risk.
At a glance
| Generic name | PITAVASTATIN |
|---|---|
| Sponsor | Kowa Co |
| Drug class | HMG-CoA Reductase Inhibitor |
| Target | 3-hydroxy-3-methylglutaryl-coenzyme A reductase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2009 |
Approved indications
- Familial hypercholesterolemia
- Hypercholesterolemia
- Mixed hyperlipidemia
Common side effects
- Myalgia
- Myalgia
- Myalgia
- Constipation
- Constipation
- Constipation
- Diarrhea
- Diarrhea
- Diarrhea
- Back Pain
- Back Pain
- Back Pain
Drug interactions
- choline fenofibrate
- ciclosporin
- clarithromycin
- clofibrate
- erythromycin
- fenofibrate
- gemfibrozil
- lopinavir
- nicotinamide
- nicotinic acid
- nicotinyl alcohol
- rifampicin
Key clinical trials
- TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men (PHASE2)
- A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (PHASE1)
- Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
- Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides (PHASE4)
- Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy (PHASE1,PHASE2)
- Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer (PHASE1)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- LATAM LOWERS LDL-C (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Livalo CI brief — competitive landscape report
- Livalo updates RSS · CI watch RSS
- Kowa Co portfolio CI