Clinical Trials

Pravastatin sodium is supported by numerous clinical trials spanning Early Phase 1 through Phase 4 evaluations for indications ranging from metabolic and cardiovascular conditions to oncological, autoimmune, and infectious diseases. Sponsored by major academic, corporate, and clinical institutions, these studies encompass completed, actively recruiting, active not recruiting, and withdrawn recruitment statuses. This broad research landscape demonstrates both established cardiovascular applications and emerging secondary therapeutic uses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06912763 RECRUITING
Fibrosis Syndrome; Lymphedema; Head &Amp; Neck Cancer; Fibrosis
M.D. Anderson Cancer Center
 2025-08-08 PHASE2
NCT05251129 WITHDRAWN
Vasculopathy
Montefiore Medical Center
 2025-01
NCT06494111 RECRUITING
Lymphedema; Fibrosis
M.D. Anderson Cancer Center
 2025-02-13 PHASE2
NCT06785727 NOT_YET_RECRUITING
Ischemic Stroke; Transient Ischemic Attack
Prof. dr. Nathalie van der Velde
 2025-02-01 PHASE4
NCT07217938 RECRUITING
Radiation-associated Dysphagia; Head &Amp; Neck Cancer
Peter MacCallum Cancer Centre, Australia
 2025-12-05 PHASE2
NCT06856772 NOT_YET_RECRUITING
Cardiovascular Diseases (CVD); Drug Effect; Atherosclerosis Cardiovascular Disease
Tor Biering-Sørensen
 2025-02-28 PHASE4
NCT07704918 RECRUITING
Melanoma
University of Colorado, Denver
 2026-12-31
NCT07098975 RECRUITING
Preeclampsia (PE); Intrauterine Growth Restriction (IUGR); Placental Insufficiency
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2026-01-14 PHASE2
NCT06324396 RECRUITING
Fontan Circulation
Children's Mercy Hospital Kansas City
 2024-03-01 PHASE1
NCT03127631 ACTIVE_NOT_RECRUITING
Prostate Cancer; Cardiovascular Disease
McMaster University
 2015-10-21
NCT04356209 RECRUITING
Breast Cancer
Institut du Cancer de Montpellier - Val d'Aurelle
 2020-01-31 PHASE2
NCT04284657 COMPLETED
Autosomal Dominant Polycystic Kidney Disease
University of Southern California
 2019-01-30 PHASE2
NCT06262685 UNKNOWN
Cardiovascular Diseases; Dyslipidemias; Statin Adverse Reaction; Pharmacogenic Myopathy
Instituto de Investigación Hospital Universitario La Paz
 2024-03-04 PHASE4
NCT05524246 COMPLETED
Hematopoietic Stem Cell Transplant (HSCT); Endothelial Injury
Children's Hospital Medical Center, Cincinnati
 2023-01-27 PHASE1
NCT03273413 ACTIVE_NOT_RECRUITING
ADPKD; Autosomal Dominant Polycystic Kidney
University of Colorado, Denver
 2017-08-31 PHASE4
NCT06357104 COMPLETED
COVID-19 Vaccine Adverse Reaction
Pachankis, Yang I., M.D.
 2024-02-26 PHASE4
NCT01717586 COMPLETED
Preeclampsia
The University of Texas Medical Branch, Galveston
 2012-08 PHASE1
NCT05852769 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-05-31 PHASE1
NCT04385433 TERMINATED
Breast Cancer
Institut du Cancer de Montpellier - Val d'Aurelle
 2020-12-04 PHASE3
NCT04190433 WITHDRAWN
Breast Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Lymphoma; Sarcoma
Mayo Clinic
 2020-09-01 PHASE2
NCT03456102 COMPLETED
Tuberculosis
Johns Hopkins University
 2020-03-09 PHASE2
NCT03882177 COMPLETED
Tuberculosis; Pulmonary Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-02-21 PHASE2
NCT00916747 UNKNOWN
Progeria
Boston Children's Hospital
 2009-08 PHASE2
NCT04640571 COMPLETED
Bile Salt Export Pump (BSEP) Transporter; Polysorbate 80
University of Maryland, Baltimore
 2021-04-01 PHASE4
NCT04719481 UNKNOWN
Postmenopausal Osteoporosis
Peking University Third Hospital
 2021-11 PHASE4
NCT03944512 TERMINATED
Preeclampsia; Obstetric Labor Complications; Hypertension in Pregnancy
The George Washington University Biostatistics Center
 2019-07-17 PHASE3
NCT02841774 COMPLETED
HIV Infection; Coronary Heart Disease
Matthew Feinstein
 2016-11 PHASE2
NCT04425902 COMPLETED
HIV Infections
ViiV Healthcare
 2020-12-16 PHASE1
NCT02871687 COMPLETED
Healthy Subjects
Brigham and Women's Hospital
 2016-04 PHASE1
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
 2018-05-31 PHASE3
NCT04608344 COMPLETED
Rheumatoid Arthritis
Gilead Sciences
 2020-11-04 PHASE1
NCT04356209 Recruiting
Breast Cancer
Institut du Cancer de Montpellier - Val d''Aurelle
 2020-09-28 Phase 2
NCT03648970 UNKNOWN
Pre-Eclampsia
Universitas Airlangga
 2018-03-01 PHASE2
NCT03456102 Completed
Tuberculosis
Johns Hopkins University
 2020-03-09 Phase 2
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
 2018-08-31 PHASE3
NCT04092751 COMPLETED
Pharmacokinetics
Scynexis, Inc.
 2019-11-22 PHASE1
NCT01268202 COMPLETED
Fibrosis
Gustave Roussy, Cancer Campus, Grand Paris
 2010-12-17 PHASE2
NCT02992548 COMPLETED
Chronic Kidney Disease
Dong-A University
 2015-09 PHASE4
NCT03219372 TERMINATED
Hepatocellular Carcinoma; Liver Cirrhoses
Cedars-Sinai Medical Center
 2018-09-27 PHASE2
NCT00840177 COMPLETED
Leukemia
SWOG Cancer Research Network
 2009-12-10 PHASE2
NCT03801733 COMPLETED
Drug Interaction Potentiation
Akebia Therapeutics
 2018-06-17 PHASE1
NCT02484261 TERMINATED
Leukemia
Reuven Schore
 2015-05 PHASE1
NCT01857921 COMPLETED
Coronary Artery
Yonsei University
 2010-12
NCT02166593 COMPLETED
Combined Dyslipidemia
Yooyoung Pharmaceutical Co., Ltd.
 2014-05 PHASE3
NCT01816997 UNKNOWN
Diabetes
Taipei Veterans General Hospital, Taiwan
 2012-01 PHASE4
NCT03131973 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
 2017-05-13 PHASE1
NCT02754739 COMPLETED
Diabetes Mellitus; Prediabetic State
Samsung Medical Center
 2014-04-15 PHASE4
NCT01872845 COMPLETED
Coronary Artery Occlusive Disease
Yonsei University
 2013-06-12
NCT01357486 COMPLETED
Hepatocellular Carcinoma; CHILD B
University Hospital, Bordeaux
 2011-11-14 PHASE2
NCT01845428 COMPLETED
Nephrotic Syndrome; Hyperlipidemia
University of North Carolina, Chapel Hill
 2012-05 PHASE1
NCT02360826 COMPLETED
Drug Distribution
Children's Mercy Hospital Kansas City
 2014-06-17 PHASE1
NCT02155530 COMPLETED
Coronary Artery Disease
Yonsei University
 2014-06
NCT02621957 COMPLETED
Breast Cancer
Genentech, Inc.
 2015-12 PHASE1
NCT02547402 COMPLETED
Acute Kidney Injury
Complexa, Inc.
 2015-12 PHASE1
NCT02578277 COMPLETED
HIV Infections
ViiV Healthcare
 2015-11-09 PHASE1
NCT01418729 COMPLETED
Advanced Hepatocarcinoma
Hospital Donostia
 2011-09 PHASE2
NCT01075555 COMPLETED
Liver Cancer
Federation Francophone de Cancerologie Digestive
 2010-02 PHASE3
NCT02431013 UNKNOWN
Dyslipidemias; Peripheral Artery Disease
Ajou University School of Medicine
 2015-04 PHASE1
NCT01557075 UNKNOWN
Drug-eluting Stent (DES)
Yonsei University
 2010-07 PHASE4
NCT02456844 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
 2015-05 PHASE1
NCT01788254 COMPLETED
Genotype-related Drug Metabolism
Matthias Schwab
 2012-01 PHASE1
NCT01502904 COMPLETED
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Yonsei University
 2010-07 PHASE4
NCT01831232 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Refractory Anemia With Excess Blasts; Untreated Adult Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
 2013-05
NCT00221104 COMPLETED
Ischemic Stroke
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
 2004-03-01 PHASE3
NCT01515813 WITHDRAWN
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2011-11 PHASE2
NCT02079974 WITHDRAWN
Endometriosis
Dr. Robert F. Casper
 2014-07
NCT01173939 TERMINATED
Hypercholesterolemia; Type 2 Diabetes; Hypertension
Positive Trial Group
 2010-07
NCT02045966 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-02 PHASE1
NCT01856374 COMPLETED
Multi-vessel Diseases, Angina
Yonsei University
 2011-08 PHASE4
NCT01958489 COMPLETED
Healthy Volunteers
Eli Lilly and Company
 2013-10 PHASE1
NCT01934569 COMPLETED
Healthy
Pfizer
 2013-09 PHASE1
NCT01903694 COMPLETED
Child-Pugh A Hepatocellular Carcinoma
Centre Hospitalier Universitaire Dijon
 2010-03 PHASE3
NCT01857843 COMPLETED
Acute Coronary Syndrome
Yonsei University
 2009-11 PHASE4
NCT01845194 COMPLETED
Drug Biotransformation; Membrane Transport
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
 2009-12 PHASE1
NCT01497483 COMPLETED
Healthy
University of California, San Francisco
 2011-12 PHASE1
NCT00701285 COMPLETED
Chronic Heart Failure
JW Pharmaceutical
 2008-07 PHASE4
NCT00731016 COMPLETED
Hutchinson-Gilford Progeria Syndrome
Assistance Publique Hopitaux De Marseille
 2008-10 PHASE2
NCT01301066 COMPLETED
Dyslipidemia
Kowa Research Institute, Inc.
 2010-12 PHASE4
NCT00467831 TERMINATED
Hermansky-Pudlak Syndrome (HPS); Pulmonary Fibrosis; Oculocutaneous Albinism; Platelet Storage Pool Deficiency; Metabolic Disease
National Human Genome Research Institute (NHGRI)
 2007-04 PHASE1; PHASE2
NCT00456365 COMPLETED
Polycystic Kidney, Autosomal Dominant
University of Colorado, Denver
 2006-11 PHASE3
NCT01082588 COMPLETED
Schizophrenia; Schizoaffective Disorders; Schizophreniform Disorders
Massachusetts General Hospital
 2010-06 PHASE4
NCT01004237 COMPLETED
Hypertension; High Cholesterol
Gachon University Gil Medical Center
 2009-11 PHASE4
NCT01441908 UNKNOWN
Dyslipidemia
MaiHealth Inc
 2011-06
NCT01342887 TERMINATED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
 2011-04 PHASE1; PHASE2
NCT00433498 COMPLETED
Lung Cancer
University College, London
 2007-01 PHASE3
NCT00599625 UNKNOWN
Crohn's Disease
University of Virginia
 2004-10
NCT00843661 UNKNOWN
HIV; Hyperlipidemia; HIV Infections
Ospedale di Circolo - Fondazione Macchi
 2009-03 PHASE4
NCT01038154 UNKNOWN
Esophageal Cancer; Stomach Cancer
Hospital Donostia
 2009-11 PHASE4
NCT01256476 COMPLETED
Primary Dyslipidemia; Mixed Dyslipidemia
Kowa Research Institute, Inc.
 2010-10 PHASE4
NCT01254461 COMPLETED
Drug Interaction
AstraZeneca
 2011-02 PHASE1
NCT01325818 UNKNOWN
Coronary Disease; Hypercholesterolemia
Yokohama City University Medical Center
 2011-03 PHASE4
NCT02305355 COMPLETED
Diabetes Mellitus, Type 2; Hypertriglycemia
Kuhnil Pharmaceutical Co., Ltd.
 2009-02 PHASE4
NCT00982189 COMPLETED
HIV Infection; Cardiovascular Disease Risk
Hennepin Healthcare Research Institute
 2009-09
NCT00738972 TERMINATED
Hypertension
Fundación Lindavista del Corazón AC
 2008-01 PHASE3
NCT00688922 UNKNOWN
Acute Myocardial Infarction
Osaka Acute Coronary Insufficiency Study Group
 2008-07 PHASE4
NCT00794963 TERMINATED
Metabolic Syndrome
Northwell Health
 2008-11
NCT00702130 COMPLETED
Ventilator Associated Pneumonia
University of Thessaly
 2008-06 EARLY_PHASE1
NCT00718796 COMPLETED
Cardiovascular Disease
The Canadian College of Naturopathic Medicine
 2008-04 PHASE3
NCT00630734 COMPLETED
HIV Infections; Hyperlipidemia
University of Colorado, Denver
 2008-02 PHASE4
NCT00571194 TERMINATED
End Stage Renal Disease
Arkansas Children's Hospital Research Institute
 2007-09 PHASE1
NCT00879034 COMPLETED
Progeria; Hutchinson-Gilford Syndrome
Boston Children's Hospital
 2009-03 PHASE2
NCT00631189 COMPLETED
Type IIa and IIb Hypercholesterolaemia
AstraZeneca
 2007-10 PHASE4
NCT00665717 COMPLETED
HIV Infections
Radboud University Medical Center
 2008-05 PHASE1
NCT00362206 COMPLETED
Hyperlipidemia
Solvay Pharmaceuticals
 2006-09 PHASE3
NCT00639223 COMPLETED
Hypercholesterolemia; Statin-Associated Myopathy
University of Pennsylvania
 2008-01 PHASE2
NCT00405717 COMPLETED
Ischemic Heart Disease; Acute Coronary Syndromes
Shenyang Northern Hospital
 2006-02 PHASE4
NCT00459745 COMPLETED
Combined Hyperlipidemia
Shionogi
 2007-04 PHASE3
NCT00166036 COMPLETED
Diabetes Mellitus; Metabolic Syndrome X; Hypercholesterolemia
Emory University
 2004-09 PHASE2
NCT00464503 COMPLETED
Statin Induced Proteinuria
Universiteit Antwerpen
 2007-09
NCT00652327 COMPLETED
Hypercholesterolemia
Organon and Co
 2005-12 PHASE4
NCT00132717 COMPLETED
Hypercholesterolemia
Organon and Co
 2005-01-01 PHASE3
NCT00117494 COMPLETED
Hyperlipidemia; HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2005-10 PHASE4
NCT00214604 COMPLETED
Hyperlipoproteinemia Type III
AstraZeneca
 2005-02 PHASE3
NCT00177580 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of Pittsburgh
 2003-07 PHASE4
NCT00697203 COMPLETED
Dyslipidemia
Hoffmann-La Roche
 2005-07 PHASE2
NCT00257686 COMPLETED
Hypercholesterolemia or Combined Dyslipidemia
Kowa Research Europe
 2005-09 PHASE3
NCT00738296 COMPLETED
Cardiovascular Diseases
Hospital Universitario 12 de Octubre
 2005-04 PHASE4
NCT00054938 COMPLETED
Systemic Lupus Erythematosus; Lupus
Brigham and Women's Hospital
 2003-03 PHASE2
NCT00303277 COMPLETED
Alzheimer's Disease; Aging
Seattle Institute for Biomedical and Clinical Research
 2002-08 PHASE4
NCT00830258 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2005-04 PHASE1
NCT00829309 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2005-03 PHASE1
NCT00529178 COMPLETED
Hypercholesterolemia
Bristol-Myers Squibb
 2002-12 PHASE4
NCT00330980 COMPLETED
Dyslipidemias
University of California, San Diego
 2000-04 PHASE4
NCT00382460 COMPLETED
Actue Coronary Syndromes
Bristol-Myers Squibb
 2000-11 PHASE4
NCT00648544 COMPLETED
Therapeutic Equivalency
Mylan Pharmaceuticals Inc
 2003-07 PHASE1
NCT00650221 COMPLETED
Therapeutic Equivalency
Mylan Pharmaceuticals Inc
 2003-06 PHASE1
NCT03073018 COMPLETED
Microalbuminuria; Cardiovascular Diseases; Renal Disease
University Medical Center Groningen
 1998-04 PHASE3
NCT00755352 COMPLETED
Hypercholesterolemia
Daiichi Sankyo
 2002-11 PHASE4
NCT00688896 COMPLETED
Type II Hyperlipidemia
Akros Pharma Inc.
 2002-06 PHASE2
NCT01146106 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-12 PHASE1
NCT01146093 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-11 PHASE1
NCT00000542 COMPLETED
Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Hypertension; Myocardial Infarction; Myocardial Ischemia; Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)
 1993-08 PHASE3
NCT00834379 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2000-09 PHASE1
NCT00834847 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2000-08 PHASE1
NCT02229773 COMPLETED
Healthy
Boehringer Ingelheim
 2000-01 PHASE1
NCT02266485 COMPLETED
Healthy
Boehringer Ingelheim
 1998-07 PHASE1
NCT01057654 COMPLETED
Hypercholesterolemia; Hyperlipoproteinemia
University Hospital, Bonn
 1996-01 PHASE3
NCT00000941 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00211705 COMPLETED
Hyperlipidemia
Mitsukoshi Health and Welfare Foundation
 1994-02 PHASE4
NCT00305201 WITHDRAWN
Kawasaki Disease
Pontificia Universidad Catolica de Chile
 2006-04 PHASE2
NCT00000461 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1986-12 PHASE2
NCT00654537 COMPLETED
Hypercholesterolemia
AstraZeneca
 2001-04 PHASE3
NCT00221754 COMPLETED
HIV Infection; Hypercholesterolemia
University Hospital, Bordeaux
 2003-03 PHASE2
NCT00107523 COMPLETED
Leukemia
Fred Hutchinson Cancer Center
 2005-01 PHASE1
NCT00005117 UNKNOWN
Heart Diseases
National Center for Research Resources (NCRR)
NCT00380939 COMPLETED
Coronary Arteriosclerosis
Pfizer
 1999-04 PHASE4
NCT00005010 COMPLETED
End-Stage Renal Disease; Chronic Allograft Nephropathy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00227500 COMPLETED
HIV Infections; Lipid Metabolism; Glucose Metabolism; Metabolic Abnormality; Lipodystrophy; Cardiovascular Disease
Kirby Institute
 2001-07 PHASE4
NCT00017758 COMPLETED
HIV Infections; HIV Seronegativity; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00039663 COMPLETED
HIV Infections
National Institutes of Health Clinical Center (CC)
 2002-05 PHASE1
NCT00006412 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00200655 COMPLETED
Relapsing-remitting Multiple Sclerosis
Nantes University Hospital
 2004-12 PHASE3
NCT00000539 COMPLETED
Arterial Occlusive Diseases; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Diabetes Mellitus
National Heart, Lung, and Blood Institute (NHLBI)
 1992-09 PHASE3
NCT00245388 COMPLETED
Dyslipidemia
Bristol-Myers Squibb
 2002-04 PHASE2; PHASE3
NCT00402376 TERMINATED
Heart Failure
University Hospital, Strasbourg, France
 2007-04 PHASE4
NCT00549926 COMPLETED
Coronary Disease; Hypercholesterolemia
Yokohama City University Medical Center
 2007-10 PHASE4
NCT00384618 TERMINATED
Chronic Kidney Disease
Amsterdam UMC, location VUmc
 2001-05 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-24)

Check the Pravastatin (CS-514) Sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pravastatin sodium competitively inhibits HMG-CoA reductase with an IC50 of 5.6 μM, blocking the conversion of HMG-CoA to mevalonate and subsequently suppressing hepatic sterol biosynthesis. This inhibition depletes intracellular cholesterol pools to stimulate low-density lipoprotein receptor expression, providing the biochemical basis for reducing plasma lipid levels in clinical conditions such as hypercholesterolemia and cardiovascular disease.

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.