Clinical Trials

Numerous clinical trials evaluate pitavastatin across diverse indications, including hypercholesterolemia, mixed dyslipidemia, coronary artery disease, atherosclerotic cardiovascular disease, type II diabetes, and metastatic pancreatic cancer. Ranging from Early Phase 1 through Phase 4—alongside pharmacokinetic and drug-drug interaction assessments in healthy volunteers—these studies are sponsored by both industry pharmaceutical companies and academic institutions. Participating protocols encompass various recruitment statuses, including completed, actively recruiting, active not recruiting, withdrawn, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06722521 RECRUITING
Primary Prevention; Vascular Calcification
Asan Medical Center
 2025-07-09 PHASE4
NCT06767774 RECRUITING
ASCVD; Diabetes; Statin
Korea University Anam Hospital
 2025-04-25 PHASE4
NCT07626840 NOT_YET_RECRUITING
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Samsung Medical Center
 2026-06-01
NCT07774975 NOT_YET_RECRUITING
Retinitis Pigmentosa (RP)
Kyushu University
 2026-09-15 PHASE1
NCT07460960 RECRUITING
Erectile Dysfunction Due to Arterial Disease; Atheroscleroses; Erectile Disfunction; Endothelial Dysfunction; Androgen Profile; Testosterone
Lomonosov Moscow State University Medical Research and Educational Center
 2026-03-05 PHASE2
NCT05705804 RECRUITING
Dyslipidemias; Atherosclerotic Cardiovascular Disease
Yonsei University
 2023-06-13
NCT07549958 RECRUITING
Pancreatic Cancer; Pancreatic Cancer Metastatic
University of California, Irvine
 2026-03-24 PHASE1
NCT07784621 NOT_YET_RECRUITING
Hypertension
Huons Co., Ltd.
 2026-10 PHASE1
NCT06982131 RECRUITING
Overweight; Obesity
Hoffmann-La Roche
 2025-06-04 PHASE1
NCT07726368 NOT_YET_RECRUITING
Non-alcoholic Fatty Liver Disease (NAFLD); Dyslipidaemia
Eccogene
 2026-07 PHASE1
NCT07567781 COMPLETED
Healthy Volunteers
AbbVie
 2026-04-30 PHASE1
NCT06317051 ACTIVE_NOT_RECRUITING
HIV Infections; Weight Gain
Kirby Institute
 2024-12-16 PHASE3
NCT07351565 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer
Chang Chen
 2026-01-10 PHASE1
NCT07442630 ACTIVE_NOT_RECRUITING
Hypercholesterolemia
JW Pharmaceutical
 2023-08-21 PHASE4
NCT06273215 UNKNOWN
Diabetes
Peking University Third Hospital
 2023-03-05 PHASE4
NCT06813924 COMPLETED
Healthy Volunteers Sickle Cell Disease, Thalassemia
Novo Nordisk A/S
 2025-02-06 PHASE1
NCT06808646 COMPLETED
Drug-drug Interaction Study
Basilea Pharmaceutica
 2025-01-17 PHASE1
NCT06262685 UNKNOWN
Cardiovascular Diseases; Dyslipidemias; Statin Adverse Reaction; Pharmacogenic Myopathy
Instituto de Investigación Hospital Universitario La Paz
 2024-03-04 PHASE4
NCT04512105 COMPLETED
Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia; AML, Adult; CLL; CLL, Relapsed; CLL, Refractory
University of California, Irvine
 2020-12-02 PHASE1
NCT05977738 COMPLETED
Glioblastoma Multiforme, Adult; Recurrent Glioblastoma
C.Dirven
 2024-01-18 EARLY_PHASE1
NCT05747768 UNKNOWN
Chronic Kidney Disease
Peking University Third Hospital
 2022-07-15 PHASE4
NCT05537948 ACTIVE_NOT_RECRUITING
Dyslipidemias; Hyperlipidemias; Liver Transplant Disorder; Immunosuppression; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Statins
National Medical Research Center for Therapy and Preventive Medicine
 2021-10-01 PHASE4
NCT03070223 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2017-03-14 PHASE3
NCT02344290 COMPLETED
HIV; Cardiovascular Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-03-26 PHASE3
NCT02956590 COMPLETED
Dyslipidemia; Obesity
Carelon Research
 2018-05-01 PHASE3
NCT04945122 UNKNOWN
Acute Myocardial Infarction; Glucose Metabolism Disorders
Chinese Academy of Medical Sciences, Fuwai Hospital
 2015-10-01 PHASE4
NCT06359353 COMPLETED
Osteoporosis, Osteopenia; Hypercholesterolemia; Menopausal Osteoporosis
Seoul National University Bundang Hospital
 2019-04-08 PHASE4
NCT03418974 UNKNOWN
Dyslipidemias
Fudan University
 2017-11-01 PHASE4
NCT04705909 UNKNOWN
Breast Cancer
Mansoura University
 2021-01-15 PHASE2; PHASE3
NCT04643093 COMPLETED
Primary Hypercholesterolemia; Mixed Dyslipidemias
Orient Pharma Co., Ltd.
 2020-08-01 PHASE3
NCT04289662 COMPLETED
Hypercholesterolemia
Kowa Company, Ltd.
 2020-03-23 PHASE3
NCT02863185 COMPLETED
Chronic Kidney Disease
Dong-A University
 2016-05-01 PHASE4
NCT04584736 COMPLETED
Primary Hypercholesterolemia
JW Pharmaceutical
 2019-06-11 PHASE3
NCT03606824 UNKNOWN
Dyslipidemia; Subclinical hypothyroïdism; Statin; ASCVD
Shaochun.Li
 2019-03-25
NCT03730038 COMPLETED
Dyslipidemias
Yonsei University
 2019-02-18
NCT02940366 UNKNOWN
Metabolic Syndrome
Seoul National University Hospital
 2016-12-01 PHASE4
NCT03532620 UNKNOWN
Prediabetic State; Hypertension; Dyslipidemias
Jun Tao
 2018-08-09 PHASE4
NCT03717064 COMPLETED
Healthy Volunteers
Hoffmann-La Roche
 2018-11-07 PHASE1
NCT02545231 COMPLETED
Atherosclerosis; Neointima; Angina
Korea University Anam Hospital
 2013-02 PHASE4
NCT03311841 COMPLETED
Renal Insufficiency
Merck Sharp & Dohme LLC
 2018-03-01 PHASE1
NCT02290106 COMPLETED
Obesity; Fatty Liver, Nonalcoholic
Massachusetts General Hospital
 2015-03-02
NCT03618797 COMPLETED
Complex-dyslipidemia
Hanlim Pharm. Co., Ltd.
 2015-11 PHASE3
NCT02743260 COMPLETED
Healthy
University of Cologne
 2016-04 PHASE4
NCT02888327 COMPLETED
Influenza in Humans
Alios Biopharma Inc.
 2016-07-31 PHASE1
NCT02056847 COMPLETED
HbA1c Level Associated With Lipid Compositions
JW Pharmaceutical
 2013-09 PHASE4
NCT02144922 COMPLETED
Hypertension; Cardiovascular Risk
Asan Medical Center
 2014-05 PHASE4
NCT01042730 COMPLETED
Coronary Artery Disease
Juntendo University
 2010-02
NCT02595268 COMPLETED
Healthy
Janssen Research & Development, LLC
 2015-11 PHASE1
NCT01648829 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
 2014-01 PHASE4
NCT02634034 COMPLETED
Hyperlipidemia
Kowa Research Institute, Inc.
 2015-12 PHASE1
NCT01502904 COMPLETED
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Yonsei University
 2010-07 PHASE4
NCT02442700 COMPLETED
HIV; Dyslipidemia
Ramathibodi Hospital
 2014-05 PHASE4
NCT02250976 COMPLETED
Healthy Male Volunteers
Hanlim Pharm. Co., Ltd.
 2014-09 PHASE1
NCT01871792 UNKNOWN
Contrast-induced Nephropathy
Gachon University Gil Medical Center
 2013-06 PHASE4
NCT00861861 COMPLETED
Hypercholesterolemia; Coronary Artery Disease
Kumamoto University
 2008-09 PHASE4
NCT01660191 COMPLETED
Hypercholesterolemia
University of Kansas Medical Center
 2011-12 PHASE4
NCT00701285 COMPLETED
Chronic Heart Failure
JW Pharmaceutical
 2008-07 PHASE4
NCT01764178 COMPLETED
Hyperlipidemia; Hypertension
JW Pharmaceutical
 2013-01-22 PHASE1
NCT01767610 COMPLETED
Healthy Male Volunteers
Hanlim Pharm. Co., Ltd.
 2013-01 PHASE1
NCT01301066 COMPLETED
Dyslipidemia
Kowa Research Institute, Inc.
 2010-12 PHASE4
NCT01695954 COMPLETED
Hyperlipidemia; HIV
NYU Langone Health
 2012-05 PHASE1
NCT01402843 COMPLETED
Hypertension; Dyslipidemia
JW Pharmaceutical
 2011-06 PHASE3
NCT01595828 COMPLETED
Metabolic Syndrome
Kowa Research Europe
 2010-10 PHASE1
NCT01386853 UNKNOWN
Hyperlipidemia
Tai Tien Pharmaceuticals Co., Ltd.
 2011-07 PHASE3
NCT00301392 COMPLETED
Diabetes Mellitus; Glucose Intolerance
Tokyo University
 2006-04 PHASE4
NCT00548145 TERMINATED
Alzheimer Disease; Hypercholesterolemia
Osaka University
 2007-11
NCT01406431 COMPLETED
Hyperlipidemia; Hypertension
JW Pharmaceutical
 2011-08 PHASE1
NCT01422382 COMPLETED
Healthy
Kowa Research Institute, Inc.
 2011-05 PHASE4
NCT01422369 COMPLETED
Healthy
Kowa Research Institute, Inc.
 2011-04 PHASE4
NCT01256476 COMPLETED
Primary Dyslipidemia; Mixed Dyslipidemia
Kowa Research Institute, Inc.
 2010-10 PHASE4
NCT01232049 COMPLETED
Healthy
Asan Medical Center
 2010-10 PHASE1
NCT00640276 COMPLETED
Hypercholesterolemia; Metabolic Syndrome
JW Pharmaceutical
 2008-04 PHASE4
NCT00846118 TERMINATED
Cardiovascular Disease
Chieko Hamada
 2009-02-01
NCT01057433 COMPLETED
Healthy Volunteers
Kowa Research Institute, Inc.
 2010-01 PHASE4
NCT01166633 COMPLETED
Hypercholesterolemia
JW Pharmaceutical
 2009-06 PHASE4
NCT01178853 COMPLETED
Healthy
Kowa Research Institute, Inc.
 2010-07 PHASE4
NCT01043094 COMPLETED
Severe Renal Impairment
Kowa Research Institute, Inc.
 2009-12 PHASE4
NCT00711919 UNKNOWN
Hyperlipidemia; Carotid Artery Diseases
Kyoto Prefectural University of Medicine
 2007-07
NCT00889226 COMPLETED
Hypercholesterolemia With Type2DM
JW Pharmaceutical
 2008-04 PHASE4
NCT00786734 WITHDRAWN
Percutaneous Coronary Intervention
JW Pharmaceutical
 2008-08 PHASE4
NCT00444717 COMPLETED
Metabolic Syndrome; Oxidative Stress; Inflammation
Aichi Gakuin University
 2007-04 PHASE4
NCT00716846 COMPLETED
Healthy Volunteers
Hamamatsu University
 2006-06
NCT00344370 COMPLETED
Type II Diabetes Mellitus; Dyslipidemia
Kowa Research Europe
 2006-08 PHASE3
NCT00330876 COMPLETED
Hypercholesterolemia; Dyslipidemias
Kowa Research Europe
 2006-06 PHASE3
NCT00325780 COMPLETED
Hypercholesterolemia; Dyslipidemia
Kowa Research Europe
 2006-07 PHASE3
NCT00242944 COMPLETED
Coronary Disease; Hypercholesterolemia
Kyoto University
 2005-11 PHASE4
NCT00344175 COMPLETED
Hypercholesterolemia; Dyslipidemia; Coronary Heart Disease
Kowa Research Europe
 2006-06 PHASE3
NCT00309751 COMPLETED
Type II Diabetes Mellitus; Dyslipidemia
Kowa Research Europe
 2005-12 PHASE3
NCT00309777 COMPLETED
Hypercholesterolemia; Dyslipidemia
Kowa Research Europe
 2005-09 PHASE3
NCT00309738 COMPLETED
Hypercholesterolemia; Dyslipidemia
Kowa Research Europe
 2005-09 PHASE3
NCT00257686 COMPLETED
Hypercholesterolemia or Combined Dyslipidemia
Kowa Research Europe
 2005-09 PHASE3
NCT00653913 COMPLETED
Hypercholesterolemia
Organon and Co
 2004-03 PHASE1
NCT00249249 COMPLETED
Primary Hypercholesterolemia; Dyslipidemia
Kowa Research Europe
 2005-10 PHASE3
NCT00549926 COMPLETED
Coronary Disease; Hypercholesterolemia
Yokohama City University Medical Center
 2007-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-08-07)

Check the Pitavastatin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pitavastatin functions as a potent inhibitor of HMG-CoA reductase with an IC50 of 6.8 nmol/L, blocking the rate-limiting step of endogenous cholesterol biosynthesis and markedly enhancing hepatic low-density lipoprotein receptor activity. By driving the cellular uptake and clearance of circulating low-density lipoprotein cholesterol, this mechanism underlies its efficacy in clinical trial evaluations targeting hypercholesterolemia, dyslipidemia, and cardiovascular risk reduction.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.