Clinical Trials

Multiple clinical trials evaluate gemfibrozil across Early Phase 1 through Phase 4 and non-interventional categories, with recruitment statuses including completed, terminated, withdrawn, and unknown. Investigations cover therapeutic areas such as multiple sclerosis, chronic kidney disease, preclinical Alzheimer's disease, and alcohol use disorder, alongside extensive pharmacokinetic and drug-interaction assessments in healthy volunteers. These evaluations are supported by academic institutions like the University of Pittsburgh as well as pharmaceutical sponsors including Sanofi, Eli Lilly and Company, and Astellas Pharma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05931484 WITHDRAWN
Parkinson Disease
Forest Hills Lab
 2027-11-01 PHASE2
NCT06809608 COMPLETED
Healthy Participants
Hoffmann-La Roche
 2025-02-13 PHASE1
NCT06392659 COMPLETED
Pain
Vertex Pharmaceuticals Incorporated
 2024-05-02 PHASE1
NCT05932303 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2023-07-12 PHASE1
NCT05959447 COMPLETED
Cough; Healthy
Bellus Health Inc. - a GSK company
 2023-07-26 PHASE1
NCT04956627 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2021-07-28 PHASE1
NCT05069870 UNKNOWN
Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2021-06-07 PHASE1
NCT06064539 COMPLETED
Multiple Sclerosis
Sanofi
 2020-05-18 PHASE1
NCT06064539 Completed
Multiple Sclerosis
Sanofi
 2020-05-18 Phase 1
NCT04008186 COMPLETED
Healthy Adult Subjects
Biogen
 2019-06-14 PHASE1
NCT03832595 Completed
Chronic Kidney Diseases
University of Pittsburgh|Vanderbilt University Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2019-05-01 Not Applicable
NCT03539432 TERMINATED
Alcohol Use Disorder
The Mind Research Network
 2018-05-16 PHASE2
NCT03723395 COMPLETED
Drug-drug Interaction
Seagen Inc.
 2018-09-17 PHASE1
NCT03624959 COMPLETED
Healthy Volunteer
Celgene
 2018-06-20 PHASE1
NCT02045056 COMPLETED
Preclinical Alzheimer's Disease
Gregory Jicha, 323-5550
 2014-05 EARLY_PHASE1
NCT02638597 COMPLETED
Smoking Cessation
University of Texas Southwestern Medical Center
 2015-02 PHASE2
NCT02770222 COMPLETED
Healthy Subjects
Actelion
 2016-06 PHASE1
NCT01876810 COMPLETED
Nicotine Dependence
Centre for Addiction and Mental Health
 2014-02 PHASE2
NCT02230033 COMPLETED
Healthy
Aragon Pharmaceuticals, Inc.
 2014-09 PHASE1
NCT01836198 COMPLETED
Healthy Volunteers
Eli Lilly and Company
 2013-05 PHASE1
NCT01736254 COMPLETED
Healthy Volunteers
Eli Lilly and Company
 2012-12 PHASE1
NCT01736254 Completed
Healthy Volunteers
Eli Lilly and Company
 2012-12 Phase 1
NCT01340846 COMPLETED
Cancer
GlaxoSmithKline
 2012-09-03 PHASE1
NCT01797198 COMPLETED
Drug-Drug Interaction (DDI); Healthy Subjects
Astellas Pharma Europe B.V.
 2012-04 PHASE1
NCT01797198 Completed
Drug-Drug Interaction (DDI)|Healthy Subjects
Astellas Pharma Europe B.V.|Astellas Pharma Inc
 2012-04 Phase 1
NCT01913379 COMPLETED
Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction
Astellas Pharma Europe B.V.
 2011-08 PHASE1
NCT01913379 Completed
Healthy Subjects|Pharmacokinetics|Drug-Drug Interaction
Astellas Pharma Europe B.V.|Medivation Inc.|Astellas Pharma Inc
 2011-08 Phase 1
NCT01385020 COMPLETED
Healthy Subjects
National Taiwan University Hospital
 2011-07 PHASE4
NCT01301742 COMPLETED
Healthy
Boehringer Ingelheim
 2011-02 PHASE1
NCT01376232 COMPLETED
Anaemia
GlaxoSmithKline
 2010-11-08 PHASE1
NCT01083212 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2010-03 PHASE1
NCT00966966 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2009-09 PHASE1
NCT00474201 COMPLETED
Healthy Volunteers
National Institutes of Health Clinical Center (CC)
 2007-05
NCT00566865 COMPLETED
Type 2 Diabetes Mellitus
Elixir Pharmaceuticals
 2007-11 PHASE1
NCT00800475 COMPLETED
Bioavailability
Blu Caribe
 2005-07 PHASE1
NCT00283335 COMPLETED
Coronary Heart Disease
VA Office of Research and Development
 1991-06 PHASE3
NCT00108511 COMPLETED
Hypertriglyceridemia
US Department of Veterans Affairs
 2004-10 PHASE1
NCT00000461 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1986-12 PHASE2
NCT00039663 COMPLETED
HIV Infections
National Institutes of Health Clinical Center (CC)
 2002-05 PHASE1
NCT00243672 WITHDRAWN
Atherosclerosis
University Hospital Muenster
 2005-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gemfibrozil acts as an agonist of peroxisome proliferator-activated receptor-alpha (PPARα), driving the transcription of target genes that enhance lipoprotein lipase expression and stimulate fatty acid oxidation. This transcriptional activation accelerates triglyceride clearance and alters lipid metabolism, establishing its clinical relevance in treating hypertriglyceridemia and evaluating pharmacokinetic drug-drug interactions across therapeutic clinical trials.

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.