Gentisic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed clinical trial evaluated gentisic acid for pancreatic cancer by investigating duodenal blood flow dynamics. Classified as Phase Not Applicable, the study was sponsored by academic and federal entities, including the Mayo Clinic, Northwestern University, the National Cancer Institute, and the National Institute for Biomedical Imaging and Bioengineering. This effort underscores a specialized focus on physiological responses in pancreatic cancer research.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01015820	Completed	Pancreatic Cancer	Mayo Clinic\|Northwestern University\|National Cancer Institute (NCI)\|National Institute for Biomedical Imaging and Bioengineering (NIBIB)	2010-06	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an active metabolite of salicylic acid, gentisic acid inhibits pro-inflammatory signaling cascades and neutralizes reactive oxygen species, thereby downregulating cellular oxidative stress and inflammatory mediator production. This suppression of inflammatory responses and cellular damage helps normalize microenvironmental factors, which is clinically relevant to studies investigating pancreatic cancer.

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>).