Amlexanox Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple Phase 2 clinical trials sponsored by academic and industry entities, including the University of Michigan and Access Pharmaceuticals, Inc., have evaluated Amlexanox across metabolic and inflammatory conditions such as type 2 diabetes mellitus, non-alcoholic fatty liver disease, obesity, and oral mucositis. These completed and terminated studies assessed endpoints ranging from glucose and lipid control to oral rinse efficacy. Overall, these investigations highlight the therapeutic potential of Amlexanox in managing metabolic disorders and mucosal inflammatory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01975935	COMPLETED	Diabetes Mellitus Type 2; Non-alcoholic Fatty Liver Disease; Obesity	University of Michigan	2014-01	PHASE2
NCT01842282	TERMINATED	Diabetes Mellitus Type 2; Non Alcoholic Fatty Liver Disease; Obesity	University of Michigan	2013-07-19	PHASE2
NCT01083875	COMPLETED	Oral Mucositis	Access Pharmaceuticals, Inc.	2000-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2018-11-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amlexanox acts as an inhibitor of TANK-binding kinase 1 (TBK1) and IKK-ε, blocking downstream inflammatory kinase signaling cascades and modulating cellular energy expenditure. By suppressing aberrant immunomodulatory pathways and cellular inflammatory responses, this target inhibition promotes metabolic homeostasis and tissue protection, offering clinical relevance in conditions such as type 2 diabetes, obesity, non-alcoholic fatty liver disease, and oral mucositis.

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>).