Livalo

(Pitavastatin)

ApprovedSmall molecule

Pitavastatin is used to lower cholesterol and triglycerides (fatty substances) in the blood to help reduce the risk of heart disease and stroke.[2] Livalo is currently approved and in use across 22 indications[4].[1]

Livalo is one of 594 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

593

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeApproved

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Liver TransplantActive, not recruiting

HyperlipidemiaApproved

Acute Coronary SyndromeActive, not recruiting

Angina PectorisActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

HIV-1 InfectionApproved

Coronary Artery DiseasePreclinical

Active, not recruiting

Metabolic SyndromeApproved

Approved

Cardiovascular DiseasePhase 3

Active, not recruiting

Endothelial DysfunctionPhase 1

Active, not recruiting

Liver TransplantApproved

Active, not recruiting

HyperlipidemiaApproved

Approved

Acute Coronary SyndromeApproved

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

Type 2 Diabetes MellitusApproved

Active, not recruiting

HIV-1 InfectionApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Livalo

MMedicure

Approved

1 2

Tecentriq

Roche

Preclinical

36 3

Tykerb

GSK

Preclinical

80 4

Prolia

Amgen

Preclinical

14 5

Gemzar

GGynecologic Oncology Group

Preclinical

22 6

DATROWAY

Daiichi Sankyo

Preclinical

4 7

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 8

Avastin

Roche

Preclinical

4 9

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 10

Recombinant Human Chorionic Gonadotropin

Merck & Co.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Hypercholesterolemia

NCT07442630

Phase 3Active, not recruiting

Immunodeficiency

NCT06317051

Phase 1Recruiting

Obesity

NCT06982131

Q2 2027

PreclinicalRecruiting

Dyslipidemias

NCT05705804

Clinical

Trials by Indication[1]

Statin7 trials

Effect of Pitavastatin on Bone

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT06359353·70 enrolled

A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02595268·14 enrolled

A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01301066·252 enrolled

Show 4 more trials

A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT06808646·12 enrolled

Pitavastatin on Carotid Intima-media Thickness

Unknown status·KKyoto Prefectural University of Medicine·N/A·NCT00711919·300 enrolled

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz

Completed·NNYU Langone Health·Phase 1·NCT01695954·34 enrolled

A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT03717064·18 enrolled

Hypercholesterolemia6 trials

Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

Active, not recruiting·JJW Pharmaceutical·Phase 4·NCT07442630·88 enrolled

Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Completed·KKowa Research Europe·Phase 3·NCT00344175·178 enrolled

Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Completed·KKowa Research Europe·Phase 3·NCT00330876·545 enrolled

Show 3 more trials

Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Completed·OOrient Pharma Co., Ltd.·Phase 3·NCT04643093·390 enrolled

Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Completed·KKowa Research Europe·Phase 3·NCT00325780·1,355 enrolled

Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Completed·JJW Pharmaceutical·Phase 4·NCT01166633·200 enrolled

Efficacy and Safety5 trials

Efficacy and Safety of Pitavastatin in a Real-world Setting

Completed·JJW Pharmaceutical··NCT04402112·28,343 enrolled

Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients

Completed·KKowa Research Europe·Phase 3·NCT00257686·962 enrolled

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Completed·KKowa Research Europe·Phase 3·NCT00309738·355 enrolled

Show 2 more trials

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Completed·KKowa Research Europe·Phase 3·NCT00309777·857 enrolled

Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients

Unknown status·TTai Tien Pharmaceuticals Co., Ltd.·Phase 3·NCT01386853·200 enrolled

Interaction5 trials

Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)

Completed·OOrganon and Co·Phase 1·NCT00653913·18 enrolled

Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01057433·24 enrolled

Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01422369·28 enrolled

Show 2 more trials

Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01422382·28 enrolled

A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872

Completed·AAlios Biopharma Inc.·Phase 1·NCT02888327·68 enrolled

Metabolic Syndrome3 trials

Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Completed·—·Phase 4·NCT00444717·100 enrolled

Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome

Unknown status·SSeoul National University Hospital·Phase 4·NCT02940366·500 enrolled

Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

Completed·JJW Pharmaceutical·Phase 4·NCT00640276·187 enrolled

33 more indications

Diabetes Mellitus2 trials

Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Completed·KKowa Research Europe·Phase 3·NCT00344370·214 enrolled

Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Completed·KKowa Research Europe·Phase 3·NCT00309751·418 enrolled

Obesity2 trials

Dyslipidemia of Obesity Intervention in Teens

Completed·CCarelon Research·Phase 3·NCT02956590·122 enrolled

A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

Recruiting· Roche logo

Roche·Phase 1·NCT06982131·40 enrolled

Acute Coronary Syndrome2 trials

Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)

Completed·YYokohama City University Medical Center·Phase 4·NCT00549926·200 enrolled

Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)

Completed·KKyoto University·Phase 4·NCT00242944·307 enrolled

Type 2 Diabetes Mellitus1 trial

Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

Completed·JJW Pharmaceutical·Phase 4·NCT00889226·161 enrolled

Angina Pectoris1 trial

Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)

Withdrawn·JJW Pharmaceutical·Phase 4·NCT00786734

Chronic Lymphocytic Leukemia1 trial

Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia

Completed·UUniversity of California, Irvine·Phase 1·NCT04512105·6 enrolled

Mild to Moderate Alzheimer's Disease1 trial

The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease

Terminated·OOsaka University·N/A·NCT00548145·38 enrolled

Cardiovascular Disease1 trial

Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT02344290·7,769 enrolled

Midazolam1 trial

Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Completed·HHamamatsu University·N/A·NCT00716846·11 enrolled

Dyslipidemia1 trial

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

Completed·RRamathibodi Hospital·Phase 4·NCT02442700·24 enrolled

Drug Transporter1 trial

Drug Transporter Interaction Study PHENTRA_2015_KPUK

Completed·UUniversity of Cologne·Phase 4·NCT02743260·24 enrolled

Chronic Kidney Disease1 trial

Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Completed·—·Phase 4·NCT02863185·45 enrolled

Hemodialysis1 trial

Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)

Terminated·CChieko Hamada·N/A·NCT00846118·905 enrolled

Platelet Reactivity1 trial

PharmacOdynamic compaRison of piTavastatin Versus atOrvastatin on Platelet Reactivity

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01648829·100 enrolled

PrEP1 trial

PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT03070223·602 enrolled

Nephropathy1 trial

Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction

Unknown status·GGachon University Gil Medical Center·Phase 4·NCT01871792·404 enrolled

Stent Restenosis1 trial

Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

Completed·KKorea University Anam Hospital·Phase 4·NCT02545231·1,000 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Unknown status·FFudan University·Phase 4·NCT03418974·10,000 enrolled

Insulin Sensitivity1 trial

Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

Completed·MMassachusetts General Hospital·N/A·NCT02290106·50 enrolled

Heart Failure1 trial

South Korean Pitavastatin Heart Failure Study

Completed·JJW Pharmaceutical·Phase 4·NCT00701285·70 enrolled

Immunodeficiency1 trial

Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)

Active, not recruiting·KKirby Institute·Phase 3·NCT06317051·300 enrolled

Treatment1 trial

The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment

Unknown status·JJW Pharmaceutical··NCT04270344·905 enrolled

Single Dose1 trial

Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01043094·16 enrolled

Drug1 trial

A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT06813924·37 enrolled

Atorvastatin1 trial

Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

Completed·KKowa Research Europe·Phase 3·NCT00249249·830 enrolled

Liver Transplant1 trial

Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients

Active, not recruiting·UUnknown Sponsor·Phase 4·NCT05537948·59 enrolled

Coronary Artery Disease1 trial

Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)

Completed·KKumamoto University·Phase 4·NCT00861861·129 enrolled

Endothelial Dysfunction1 trial

Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome

Completed·KKowa Research Europe·Phase 1·NCT01595828·14 enrolled

Hyperlipidemia1 trial

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01256476·328 enrolled

Abnormal Glucose Metabolism1 trial

Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism

Unknown status·—·Phase 4·NCT04945122·900 enrolled

Breast Cancer1 trial

Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer

Unknown status·MMansoura University·Phase 2/3·NCT04705909·60 enrolled

Hypertensive1 trial

Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients

Completed·—·Phase 4·NCT02144922·85 enrolled

Dyslipidemias1 trial

Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial

Recruiting·YYonsei University·Preclinical·NCT05705804·250 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 3, 2009

LIVALO

NDA NDA022363

Jul 14, 2017

ZYPITAMAG

NDA NDA208379

Aug 4, 2017

NIKITA

NDA NDA209875

Sources

References

[1]
ClinicalTrials.gov — 62 trial records for Pitavastatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Livalo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pitavastatin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pitavastatin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209875). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Livalo. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Medicure company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: HMG-Coa Reductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMedicure

Patent Landscape[6]

Patent Cliff

Jan 19, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8829186Jan 19, 2031

Livalo

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Statin7 trials

Hypercholesterolemia6 trials

Efficacy and Safety5 trials

Interaction5 trials

Metabolic Syndrome3 trials

Diabetes Mellitus2 trials

Obesity2 trials

Acute Coronary Syndrome2 trials

Type 2 Diabetes Mellitus1 trial

Angina Pectoris1 trial

Chronic Lymphocytic Leukemia1 trial

Mild to Moderate Alzheimer's Disease1 trial

Cardiovascular Disease1 trial

Midazolam1 trial

Dyslipidemia1 trial

Drug Transporter1 trial

Chronic Kidney Disease1 trial

Hemodialysis1 trial

Platelet Reactivity1 trial

PrEP1 trial

Nephropathy1 trial

Stent Restenosis1 trial

Safety and Efficacy1 trial

Insulin Sensitivity1 trial

Heart Failure1 trial

Immunodeficiency1 trial

Treatment1 trial

Single Dose1 trial

Drug1 trial

Atorvastatin1 trial

Liver Transplant1 trial

Coronary Artery Disease1 trial

Endothelial Dysfunction1 trial

Hyperlipidemia1 trial

Abnormal Glucose Metabolism1 trial

Breast Cancer1 trial

Hypertensive1 trial

Dyslipidemias1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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