Glycerol Clinical Trials

Size	Price	Qty
500mg	USD 97

Clinical Trials

Multiple clinical trials evaluate glycerol or glycerol-derived formulations for conditions such as corticobasal syndrome, liver cancer, and liver transplantation complications, including graft dysfunction and rejection. Sponsored by academic and regional health organizations—including Oslo University Hospital, the South-Eastern Norway Regional Health Authority, and the Technical University of Munich—these Phase II and phase-unclassified studies vary in recruitment status. Currently, protocols range from not yet recruiting for ex vivo liver perfusion to actively recruiting for glycerol phenylbutyrate.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05951231	Not yet recruiting	Liver Transplant; Complications\|Transplant; Failure Liver\|Transplant Dysfunction\|Transplant; Complication Rejection\|Transplant\|Liver Metastases\|Liver Cancer	Oslo University Hospital\|South-Eastern Norway Regional Health Authority	2024-02	Not Applicable
NCT05983588	Recruiting	Corticobasal Syndrome (CBS)	Technical University of Munich	2023-12-12	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glycerol functions as a polyol osmotic agent and molecular stabilizer that alters solvent hydration shells, thereby preventing the dissociation of nucleoprotein complexes and maintaining cell membrane integrity under physical or metabolic stress. This biochemical stabilization preserves tissue viability and cellular homeostasis, mitigating graft injury during ex vivo liver transplantation procedures and supporting therapeutic management in neurological conditions such as corticobasal syndrome.

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>).