Clinical Trials

Lovastatin has been evaluated in numerous clinical trials spanning early to late phases for both cardiovascular and non-cardiovascular indications. Sponsored by diverse entities including the National Cancer Institute and academic medical centers, these studies target lipid metabolism disorders, chronic obstructive pulmonary disease, fragile X syndrome, and malignancies such as prostate, melanoma, and advanced breast cancers. Ranging across completed, active, terminated, and pending recruitment statuses, these investigations highlight sustained biomedical interest in repurposing this metabolic inhibitor.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07619365 NOT_YET_RECRUITING
Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer
Washington University School of Medicine
 2026-08-31 PHASE2
NCT06636734 RECRUITING
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Hypopharyngeal Squamous Cell Carcinoma; Metastatic Laryngeal Squamous Cell Carcinoma; Metastatic Nasopharyngeal Squamous Cell Carcinoma; Metastatic Oral Cavity Squamous Cell Carcinoma; Metastatic Oropharyngeal Squamous Cell Carcinoma; Metastatic Paranasal Sinus Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Nasopharyngeal Squamous Cell Carcinoma; Recurrent Oral Cavity Squamous Cell Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Paranasal Sinus Squamous Cell Carcinoma; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage IV Nasopharyngeal Carcinoma AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Sinonasal Cancer AJCC v8
Emory University
 2024-12-09 PHASE2
NCT02964884 ACTIVE_NOT_RECRUITING
Neurofibromatosis Type 1; Learning Disability; Reading Disability; NF1
Vanderbilt University
 2016-11 PHASE2
NCT07282756 RECRUITING
Periodontal Diseases; Periodontitis; Periodontal Disease; Smokers
Medical University of Silesia
 2025-07-11
NCT06262685 UNKNOWN
Cardiovascular Diseases; Dyslipidemias; Statin Adverse Reaction; Pharmacogenic Myopathy
Instituto de Investigación Hospital Universitario La Paz
 2024-03-04 PHASE4
NCT04297033 UNKNOWN
Cerebral Arteriovenous Malformation
Beijing Tiantan Hospital
 2021-01-01 PHASE2
NCT06789497 COMPLETED
Drug Resistant Epilepsy; Temporal Lobe Epilepsy
University of Coimbra
 2020-01-12
NCT03504501 TERMINATED
Impaired Synaptic Plasticity; Impaired Cognition
Technical University of Munich
 2019-03-22 PHASE2
NCT04359823 COMPLETED
Actinic Porokeratosis
Medical University of South Carolina
 2020-08-24 PHASE1
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
 2018-05-31 PHASE3
NCT02998151 COMPLETED
Fragile X Syndrome
Children's Hospital Medical Center, Cincinnati
 2016-01 EARLY_PHASE1
NCT03826940 COMPLETED
Autism Spectrum Disorder; Neurofibromatosis 1
University of Coimbra
 2019-02-19
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
 2018-08-31 PHASE3
NCT03242499 UNKNOWN
Parkinson Disease
National Taiwan University Hospital
 2017-05-15 PHASE2
NCT03981601 UNKNOWN
Bone Loss
Islamic Azad University, Sanandaj
 2018-02-22 PHASE2
NCT02642653 COMPLETED
Fragile X Syndrome; Genetic Diseases
University of California, Davis
 2016-01 PHASE4
NCT02680379 COMPLETED
Fragile X Syndrome
Université de Sherbrooke
 2016-03 PHASE2
NCT00963664 WITHDRAWN
Melanoma; Malignant Melanoma
NeoPlas Innovation
 2009-12 PHASE2
NCT02563860 COMPLETED
Rett Syndrome
Montefiore Medical Center
 2015-07 PHASE2
NCT03178526 COMPLETED
Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration
Islamic Azad University, Sanandaj
 2015-12-24 PHASE2; PHASE3
NCT02603770 COMPLETED
Lipid Metabolism Disorder
Luye Pharma Group Ltd.
 2015-11 PHASE1
NCT01976936 COMPLETED
Stroke; Rhabdomyolysis; Jaundice
Columbia University
 2009-02 PHASE2
NCT00580970 COMPLETED
Prostate Cancer
Virginia Commonwealth University
 2007-04 PHASE2
NCT02389868 COMPLETED
Blood Platelets Proteome
Université de Sherbrooke
 2015-02 PHASE2
NCT00853580 COMPLETED
Neurofibromatosis Type 1
University of Alabama at Birmingham
 2009-07 PHASE2
NCT00352599 COMPLETED
Neurofibromatosis 1
University of California, Los Angeles
 2009-09 PHASE1
NCT01478828 TERMINATED
Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2012-07-13
NCT00583102 TERMINATED
Acute Myeloid Leukemia
University of Iowa
 2001-06 PHASE1; PHASE2
NCT00700921 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
National Jewish Health
 2008-04 PHASE2
NCT01478828 Terminated
Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|Patrick C Walsh Prostate Cancer Research Fund
 2012-07-13 Not Applicable
NCT01361217 COMPLETED
Drug-Drug Interaction; Healthy Volunteers
University of Washington
 2011-09
NCT00302952 TERMINATED
Rheumatoid Arthritis
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-11-06 PHASE2
NCT01527669 COMPLETED
Healthy Subjects
National Taiwan University Hospital
 2012-02 PHASE4
NCT01527669 Completed
Healthy Subjects
National Taiwan University Hospital|National Science Council Taiwan
 2012-02 Phase 4
NCT01250535 COMPLETED
Healthy Volunteers; Drug Drug Interactions
University of North Carolina, Chapel Hill
 2010-12 PHASE1
NCT00721305 COMPLETED
HIV Seropositivity
Universidad de Antioquia
 2008-08 PHASE2
NCT01385020 Completed
Healthy Subjects
National Taiwan University Hospital|National Science Council Taiwan
 2011-07 Phase 4
NCT00462280 COMPLETED
Precancerous Condition; Stage 0 Melanoma; Stage I Melanoma; Stage II Melanoma
National Cancer Institute (NCI)
 2007-05 PHASE2
NCT00902668 TERMINATED
Breast Cancer; Radiation Toxicity
Virginia Commonwealth University
 2009-04 PHASE2
NCT00285857 TERMINATED
Breast Cancer
Stanford University
 2005-11 PHASE2
NCT00585052 TERMINATED
Ovarian Cancer
University of Iowa
 2003-08 PHASE2
NCT00718796 COMPLETED
Cardiovascular Disease
The Canadian College of Naturopathic Medicine
 2008-04 PHASE3
NCT00584012 TERMINATED
Any Cancer; Breast Cancer
Susan L Roeder
 2004-04 PHASE1
NCT00243880 COMPLETED
Stroke
Columbia University
 2005-09 PHASE1
NCT00700921 Completed
Chronic Obstructive Pulmonary Disease (COPD)
National Jewish Health|National Heart Lung and Blood Institute (NHLBI)
 2008-04 Phase 2
NCT00741013 COMPLETED
Lung Inflammation
Washington University School of Medicine
 2007-03 EARLY_PHASE1
NCT00132717 COMPLETED
Hypercholesterolemia
Organon and Co
 2005-01-01 PHASE3
NCT01346670 COMPLETED
Healthy Volunteer
Taipei Medical University WanFang Hospital
 2006-10 PHASE4
NCT00685685 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2004-09 PHASE1
NCT00684723 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2004-07 PHASE1
NCT00092846 COMPLETED
Hypercholesterolemia
Merck Sharp & Dohme LLC
 2002-12-04 PHASE3
NCT00116870 COMPLETED
Atherosclerosis; Coronary Artery Disease
Merck Sharp & Dohme LLC
 1985-06 PHASE2; PHASE3
NCT00000512 COMPLETED
Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia
University of Washington
 1984-01 PHASE3
NCT00071266 COMPLETED
Intermittent Claudication; Peripheral Vascular Disease
Kos Pharmaceuticals
 2003-10 PHASE3
NCT00689806 WITHDRAWN
Severe Persistent Asthma
University of Chicago
 PHASE1; PHASE2
NCT00000477 COMPLETED
Atherosclerosis; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Hypercholesterolemia; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1990-07 PHASE2
NCT00345657 COMPLETED
Hyperlipidemia; Mixed Hyperlipidemia; Dyslipidemia
In His Image
 2003-07 PHASE4
NCT00000463 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1987-04 PHASE3
NCT00062556 COMPLETED
Intermittent Claudication; Peripheral Vascular Disease
Kos Pharmaceuticals
 2003-01 PHASE3
NCT00000469 COMPLETED
Cardiovascular Diseases; Carotid Stenosis; Cerebral Arteriosclerosis; Cerebrovascular Disorders; Heart Diseases; Vascular Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1988-05 PHASE2
NCT01110642 WITHDRAWN
Syndromic Ichthyoses; CHILD Syndrome; Smith Lemli Opitz Syndrome; Conradi Syndrome
Northwestern University
 2011-07 PHASE2
NCT00004346 UNKNOWN
Cerebrotendinous Xanthomatosis
National Center for Research Resources (NCRR)
 1996-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the Lovastatin (Mevinolin, MK-803) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lovastatin selectively binds to and inhibits HMG-CoA reductase, blocking the rate-limiting enzymatic conversion of 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate and suppressing downstream isoprenoid biosynthesis. This biochemical blockade triggers cellular autophagy and apoptotic signaling, providing therapeutic benefit by reducing lipid levels and suppressing cell proliferation in clinical conditions such as lipid metabolism disorders, prostate cancer, and melanoma.

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.