Troglitazone (CS-045) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 447

Clinical Trials

Several completed clinical trials have evaluated Troglitazone across Phase 2, Phase 3, and unspecified phases for oncological, metabolic, and cardiovascular conditions. These investigations focused on PPAR ligand therapy for sarcoma, atherosclerosis regression in diabetes mellitus, and thiazolidinedione-associated bone fracture risk. The completed studies were supported by both academic institutions and pharmaceutical sponsors, including the Dana-Farber Cancer Institute, Parke-Davis, and GlaxoSmithKline.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00116545	COMPLETED	Atherosclerosis; Diabetes Mellitus	Parke-Davis	1997-01	PHASE2; PHASE3
NCT00003058	COMPLETED	Sarcoma	Dana-Farber Cancer Institute	1997-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2009-12-11)

Check the Troglitazone (CS-045) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Troglitazone functions as a potent agonist of the peroxisome proliferator-activated receptor gamma (PPAR-γ), binding this nuclear receptor to modulate transcriptional cascades controlling gene expression involved in cell differentiation and lipid metabolism. Through the regulation of PPAR-γ responsive transcriptional pathways, the compound induces programmed cell death, autophagy, and necroptosis, demonstrating therapeutic relevance in constraining tumor growth in sarcoma and regulating metabolic parameters in type II diabetes and atherosclerosis.

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>).