Tolfenamic Acid Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

The clinical evaluation of tolfenamic acid currently comprises a clinical trial focused on central nervous system pathology, specifically a combined Phase 1 and Phase 2 study evaluating its safety, tolerability, and efficacy in progressive supranuclear palsy. Co-sponsored by NeuroTau Inc. and The Cleveland Clinic, the study's recruitment status is currently listed as unknown. Overall, clinical research on tolfenamic acid remains centered on early-phase therapeutic applications in neurodegenerative disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04253132	Unknown status	Progressive Supranuclear Palsy	NeuroTau Inc.\|The Cleveland Clinic	2021-01-01	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tolfenamic acid selectively binds to and inhibits cyclooxygenase-2 (COX-2) with an IC50 of 0.2 μM, thereby suppressing the conversion of arachidonic acid into pro-inflammatory prostaglandins and downregulating downstream inflammatory signaling cascades. By attenuating neuroinflammatory pathways and cellular stress, this targeted inhibition provides the mechanistic foundation for exploring tolfenamic acid in clinical trials for neurodegenerative conditions such as progressive supranuclear palsy.

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>).