Ciprofibrate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate ciprofibrate across cardiometabolic and vascular conditions, including dyslipidemia, hypertriglyceridemia, hypertension, atherosclerotic cardiovascular disease, impaired glucose metabolism, and diastolic dysfunction. These Phase 3, Phase 4, and phase-unspecified studies—encompassing completed, actively recruiting, and unknown recruitment status protocols—focus on endpoints such as myocardial insulin sensitivity, vascular function, and lipoprotein levels. Trial sponsors include pharmaceutical companies like Novartis and Sanofi, as well as academic institutions including Maastricht University Medical Center and Hospital Universitario Pedro Ernesto.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03662984	COMPLETED	Myocardial Insulin Sensitivity; Impaired Glucose Metabolism; Diastolic Dysfunction	Maastricht University Medical Center	2018-11-01	PHASE3
NCT01480687	UNKNOWN	Hypertension; Hypertriglyceridemia	Hospital Universitario Pedro Ernesto	2011-05	PHASE4
NCT00350038	COMPLETED	Hypertension; Dyslipidemia	Sanofi	2005-02	PHASE4

(data from https://clinicaltrials.gov, updated on 2021-01-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ciprofibrate selectively acts as a peroxisome proliferator-activated receptor agonist, triggering downstream transcriptional modulation of lipid metabolic pathways to increase fatty acid oxidation and suppress hepatic triglyceride synthesis. This cellular modulation significantly lowers plasma levels of triglycerides and low-density lipoprotein cholesterol while elevating high-density lipoprotein cholesterol, providing therapeutic efficacy in clinical conditions such as dyslipidemia, hypertriglyceridemia, and atherosclerotic 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>).