Urethane Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Several clinical trials have evaluated urethane and urethane-derived materials across diverse applications, including breast cancer surgical recovery, dental caries, HIV prevention, and decubitus ulcers. Sponsored by academic medical centers and industry entities, these studies comprise Phase 1 clinical evaluations alongside observational protocols. Their recruitment statuses range from completed to withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03159598	WITHDRAWN	Breast Cancer	Case Comprehensive Cancer Center	2020-11-01
NCT02018822	COMPLETED	Dental Caries; Restorative Material	University of Rochester	2013-06
NCT02006264	COMPLETED	HIV	Albert Einstein College of Medicine	2013-11-19	PHASE1

(data from https://clinicaltrials.gov, updated on 2020-11-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a carbamate derivative and polymeric precursor, urethane interacts with cellular macromolecules to disrupt nucleic acid synthesis or forms cross-linked matrix networks that stabilize biological tissue interfaces. This inhibition of metabolic processes and physical structural reinforcement prevent aberrant cell proliferation and maintain tissue integrity, demonstrating clinical relevance in antineoplastic therapy, restorative dentistry, and surgical tissue adhesion during breast reconstruction.

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>).