Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate fenofibric acid across primary cardiometabolic disorders—including dyslipidemia, coronary heart disease, and nonalcoholic steatohepatitis—alongside neurodegenerative and oncological conditions such as Huntington disease and pediatric central nervous system tumors. Sponsored by academic institutions and industry entities, these completed, active, terminated, and withdrawn studies assess therapeutic efficacy, combination safety, and pharmacokinetic properties.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01356290 RECRUITING
Medulloblastoma Recurrent; Ependymoma Recurrent; ATRT Recurrent; Rare CNS Tumor Recurrent
Medical University of Vienna
 2014-04 PHASE2
NCT04517396 COMPLETED
Covid19
University of Pennsylvania
 2020-08-18 PHASE2
NCT03382756 Completed
Dyslipidemias
Chong Kun Dang Pharmaceutical
 2017-10-12 Phase 1
NCT03515213 Completed
Huntington Disease
University of California Irvine
 2017-04-27 Phase 2
NCT02891408 Completed
Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences
 2016-09-23 Phase 1
NCT02651753 Completed
Dyslipidemia
Chong Kun Dang Pharmaceutical
 2016-01 Phase 1
NCT02422030 COMPLETED
Healthy
Chong Kun Dang Pharmaceutical
 2015-03-17 PHASE1
NCT02422030 Completed
Healthy
Chong Kun Dang Pharmaceutical
 2015-03-17 Phase 1
NCT01974297 UNKNOWN
Mixed Hyperlipidemia
Sang Hak Lee
 2013-07
NCT01964365 COMPLETED
Healthy
Daewoong Pharmaceutical Co. LTD.
 2013-09 PHASE1
NCT01148004 COMPLETED
HIV; Fenofibrate; Protease Inhibitors; Hypertriglyceridemia; Glucuronosyltransferase
National Institutes of Health Clinical Center (CC)
 2010-05-13 PHASE1
NCT01501435 COMPLETED
Healthy
HK inno.N Corporation
 2011-12 PHASE1
NCT01555398 COMPLETED
Healthy
Hanmi Pharmaceutical Company Limited
 2012-02 PHASE1
NCT01509196 COMPLETED
Healthy
Hanmi Pharmaceutical Company Limited
 2011-11 PHASE1
NCT01472380 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2011-11 PHASE1
NCT00973271 WITHDRAWN
Hypertriglyceridemia
Essentialis, Inc.
 2011-03 PHASE3
NCT01030328 WITHDRAWN
Coronary Atherosclerosis
Piedmont Healthcare
 2009-11 PHASE3
NCT01025492 TERMINATED
Dyslipidemia
University of Utah
 2009-11 PHASE4
NCT00839293 COMPLETED
Healthy
Abbott
 2009-02 PHASE1
NCT00808678 COMPLETED
Healthy
AstraZeneca
 2008-12 PHASE1
NCT00826358 COMPLETED
Healthy
AstraZeneca
 2008-11 PHASE1
NCT00719693 COMPLETED
Pharmacokinetic Variables
AstraZeneca
 2008-07 PHASE1
NCT00300430 COMPLETED
Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
Abbott
 2006-09 PHASE3
NCT00960570 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2008-02 PHASE1
NCT00961259 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2008-02 PHASE1
NCT00961116 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-10 PHASE1
NCT00960687 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-10 PHASE1
NCT00960856 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-11 PHASE1
NCT00300469 COMPLETED
Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia
Abbott
 2006-03 PHASE3
NCT00300482 COMPLETED
Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
Abbott
 2006-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-02-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenofibric acid selectively binds and activates peroxisome proliferator-activated receptor alpha (PPARα), which alters the transcription of genes controlling lipid metabolism and downregulates apolipoprotein C-III production. This transcriptional regulation enhances intravascular lipolysis and accelerates plasma triglyceride clearance, providing therapeutic efficacy in clinical conditions such as dyslipidemia, mixed dyslipidemia, and nonalcoholic steatohepatitis.

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.