Clinical Trials

Numerous clinical trials spanning early phase 1 through phase 4 evaluate fluvastatin across diverse therapeutic areas, sponsored by academic centers, hospital networks, and pharmaceutical entities such as Novartis. These investigations target cardiovascular, metabolic, oncologic, autoimmune, and infectious disorders—including dyslipidemia, diabetes, prostate cancer, and hepatitis C—as well as pharmacokinetic drug-drug interactions in healthy subjects. While many trials have reached completed status, others were withdrawn or terminated during development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06785727 NOT_YET_RECRUITING
Ischemic Stroke; Transient Ischemic Attack
Prof. dr. Nathalie van der Velde
 2025-02-01 PHASE4
NCT06679036 RECRUITING
Advanced Unresectable or Metastatic Breast Cancer
Shandong Suncadia Medicine Co., Ltd.
 2025-01-21 PHASE1; PHASE2
NCT06830954 NOT_YET_RECRUITING
Bioequivalence
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2025-02 PHASE1
NCT06262685 UNKNOWN
Cardiovascular Diseases; Dyslipidemias; Statin Adverse Reaction; Pharmacogenic Myopathy
Instituto de Investigación Hospital Universitario La Paz
 2024-03-04 PHASE4
NCT04285749 WITHDRAWN
Malignant Melanoma
Case Comprehensive Cancer Center
 2020-11-06 EARLY_PHASE1
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
 2018-05-31 PHASE3
NCT04029584 COMPLETED
Drug-drug Interaction
University of California, San Francisco
 2019-04-25 PHASE4
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
 2018-08-31 PHASE3
NCT02115074 COMPLETED
Glioma
Centre Oscar Lambret
 2014-06 PHASE1
NCT03189511 COMPLETED
Adipose Tissue, Brown; Insulin Resistance; Clinical Trial
University of Zurich
 2017-05-31 PHASE4
NCT01992042 COMPLETED
Prostate Cancer
University Health Network, Toronto
 2014-02 PHASE2
NCT03393377 COMPLETED
Atherosclerosis
University Medical Centre Ljubljana
 2014-09
NCT00404287 TERMINATED
Aortic Valve Stenosis
AORTICA Group
 2006-10-01 PHASE4
NCT01045512 TERMINATED
Aging; Inflammation
Martin-Luther-Universität Halle-Wittenberg
 2009-10 PHASE2
NCT02115074 Completed
Glioma
Centre Oscar Lambret|Anticancer Fund Belgium
 2014-06 Phase 1
NCT01681199 UNKNOWN
Coronary Heart Disease; Atherosclerosis
Beijing Anzhen Hospital
 2012-07 PHASE4
NCT03309618 COMPLETED
Myocardial Infarction
University Medical Centre Ljubljana
 2012-11
NCT01551173 COMPLETED
Lipid Metabolism Disorders
Novartis Pharmaceuticals
 2012-01 PHASE4
NCT01524601 COMPLETED
Disorder Related to Renal Transplantation; Hypercholesterolemia
University of Oslo School of Pharmacy
 2012-02 PHASE4
NCT01524601 Completed
Disorder Related to Renal Transplantation|Hypercholesterolemia
University of Oslo School of Pharmacy|Oslo University Hospital
 2012-02 Phase 4
NCT00674297 COMPLETED
Antiphospholipid Syndrome
Hospital for Special Surgery, New York
 2008-05 PHASE2
NCT00814606 WITHDRAWN
Hepatitis C; Hepatitis C Virus
University of Chicago
 2010-02 PHASE2
NCT00487318 COMPLETED
Chronic Hepatitis C
Bader, Ted, M.D.
 2007-06 PHASE2
NCT00814606 Withdrawn
Hepatitis C|Hepatitis C Virus
University of Chicago
 2010-02 Phase 2
NCT00223041 TERMINATED
Renal Transplantation
University Hospital Schleswig-Holstein
 2003-04 PHASE2; PHASE3
NCT00718796 COMPLETED
Cardiovascular Disease
The Canadian College of Naturopathic Medicine
 2008-04 PHASE3
NCT00176410 UNKNOWN
Aortic Valve Stenosis
University of Leipzig
 2003-01 PHASE2
NCT00421005 UNKNOWN
Heart Transplantation; Hypercholesterolemia
University of Bologna
 2004-11 PHASE4
NCT00752843 COMPLETED
Healthy Subjects
Corcept Therapeutics
 2008-09 PHASE1
NCT00752843 Completed
Healthy Subjects
Corcept Therapeutics
 2008-09 Phase 1
NCT00309257 COMPLETED
Alport Syndrome
Mario Negri Institute for Pharmacological Research
 2004-01 PHASE2
NCT00674297 Completed
Antiphospholipid Syndrome
Hospital for Special Surgery New York|University of Texas
 2008-05 Phase 2
NCT00199927 COMPLETED
Chronic Nephropathy; Proteinuria; Hypertension
Mario Negri Institute for Pharmacological Research
 2003-03 PHASE3
NCT00489424 COMPLETED
Osteoporosis
Novartis Pharmaceuticals
 2007-06 PHASE4
NCT00565474 COMPLETED
Graft Vasculopathy
Novartis Pharmaceuticals
 2001-09 PHASE4
NCT00664742 COMPLETED
Metabolic Syndrome
Novartis
 2006-09 PHASE4
NCT00416403 COMPLETED
Breast Cancer
University of California, San Francisco
 2006-07 PHASE2
NCT00814723 COMPLETED
Hypercholesterolemia
Medical University of Graz
 2005-09 PHASE4
NCT00132717 COMPLETED
Hypercholesterolemia
Organon and Co
 2005-01-01 PHASE3
NCT00171262 COMPLETED
Dyslipidemia
Novartis
 2004-08 PHASE4
NCT00441493 COMPLETED
Hepatitis C
Bader, Ted, M.D.
 2006-09
NCT00821574 COMPLETED
Hypertension, Dyslypidaemia
Novartis
 2005-07 PHASE4
NCT00385658 COMPLETED
Dyslipidemia
Novartis
 2006-08 PHASE4
NCT00171275 COMPLETED
Coronary Disease; Myocardial Infarction
Novartis
 2003-11 PHASE4
NCT00404287 Terminated
Aortic Valve Stenosis
AORTICA Group
 2006-10-01 Phase 4
NCT00136799 COMPLETED
Mixed Dyslipidemia; Hypercholesterolemia
Novartis
 2005-06 PHASE3
NCT00138528 COMPLETED
Metabolic Syndrome
Novartis
 2004-10 PHASE4
NCT00125125 COMPLETED
Dyslipidemia
Novartis
 2005-05 PHASE4
NCT00171327 COMPLETED
Hypertension; Dyslipidemia
Novartis
 2004-07 PHASE4
NCT00171288 COMPLETED
Dyslipidemia
Novartis
 2003-08 PHASE3
NCT00171236 COMPLETED
Heterozygous Familial Hypercholesterolemia; Mixed Dyslipidemia
Novartis
 2001-10 PHASE3
NCT00549926 COMPLETED
Coronary Disease; Hypercholesterolemia
Yokohama City University Medical Center
 2007-10 PHASE4
NCT00382161 WITHDRAWN
Impotence
University Hospital, Saarland
 2006-10 PHASE3
NCT00407680 UNKNOWN
Type 2 Diabetes Mellitus; Hypertension
Kitasato University
 2006-10 PHASE4
NCT00223015 COMPLETED
Renal Transplantation
University Hospital Schleswig-Holstein
 2004-05 PHASE4
NCT00223028 COMPLETED
Renal Transplantation
University Hospital Schleswig-Holstein
 2005-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-01-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluvastatin sodium competitively binds to and inhibits HMG-CoA reductase, thereby blocking the rate-limiting conversion of HMG-CoA to mevalonate and suppressing downstream endogenous hepatic cholesterol synthesis. This inhibition reduces circulating LDL-cholesterol and apolipoprotein B levels while raising HDL-cholesterol, providing the mechanistically sound basis for its clinical evaluation in hypercholesterolemia, dyslipidemia, and oncology conditions like glioma.

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.