Mesna Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated the therapeutic applications and functional effects of Mesna across diverse conditions, including obesity, end-stage renal disease, spine surgery, and implant capsular contracture. These Phase 1, Phase 2, and non-phased studies—sponsored by academic, institutional, and corporate entities such as the Universities of Oslo, Oxford, and Vanderbilt, Lawson Health Research Institute, CIHR, and AuXin Surgery SA—encompass completed evaluations of cysteine lowering and total homocysteine concentration, alongside a terminated investigation of chemically assisted capsulectomy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04449536	Completed	Obesity\|Drug Effect	University of Oslo\|Oslo University Hospital\|University of Oxford	2020-11-02	Phase 1
NCT05016739	Completed	Spine Surgery	AuXin Surgery SA	2018-10-22	Not Applicable
NCT00524199	Completed	End Stage Renal Disease	Lawson Health Research Institute\|Canadian Institutes of Health Research (CIHR)	2007-03	Phase 2
NCT00758667	Terminated	Implant Capsular Contracture	Vanderbilt University	2005-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mesna is bio-converted in the renal system into a free thiol compound that directly binds to and inactivates toxic oxazaphosphorine metabolites such as acrolein. By neutralizing these reactive electrophiles and preventing alkylation-induced urothelial cellular damage, Mesna mitigates chemotherapy-induced urinary tract toxicity and provides systemic thiol modulation relevant to clinical studies in end-stage renal disease and metabolic conditions such as obesity.

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>).