Propylthiouracil Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several completed clinical trials have evaluated propylthiouracil across various physiological and metabolic indications, including primary taste qualities, dysgeusia, and type 2 diabetes. Sponsored by academic and government institutions—such as Purdue University, the University of Cagliari, Baylor College of Medicine, and the National Institute of Diabetes and Digestive and Kidney Diseases—the associated trial phases are documented as unlisted or not applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02390180	Completed	Taste Qualities\|Primary Tastes	Purdue University	2014-10	--
NCT01097915	Completed	Dysgeusia	University of Cagliari	2009-10	--
NCT00570466	Completed	Type 2 Diabetes	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)\|Baylor College of Medicine	2008-01	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propylthiouracil binds to and inhibits thyroperoxidase and 5'-deiodinase, preventing the oxidation of iodide to iodine and blocking the peripheral conversion of thyroxine (T4) to active triiodothyronine (T3). This enzymatic blockade suppresses thyroid hormone synthesis and circulating hormone levels, providing therapeutic relevance for hyperthyroidism while supporting clinical trial investigations into dysgeusia, primary taste qualities, and type 2 diabetes.

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>).