Mefenamic Acid Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate mefenamic acid across distinct clinical contexts, spanning both corporate and academic sponsors. A completed Phase 1 drug-interaction clinical trial sponsored by Takeda investigated the impact of mefenamic acid on the pharmacokinetic profile of soticlestat in healthy volunteers. Additionally, a clinical trial sponsored by Mahidol University and Siriraj Hospital, with an unknown recruitment status, evaluated mefenamic acid for procedural pain relief during saline infusion sonohysterography in patients with infertility.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05064449	Completed	Healthy Volunteers	Takeda	2021-10-14	Phase 1
NCT01060696	Unknown status	Infertility	Mahidol University\|Siriraj Hospital	2009-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mefenamic acid acts as a competitive inhibitor of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby blocking downstream prostaglandin biosynthesis to diminish localized inflammatory cascades and pain signal transmission. This inhibition of pro-inflammatory mediator production provides the therapeutic rationale for its use in pain mitigation, such as managing procedural discomfort in infertility interventions, and supports its assessment in clinical pharmacokinetic drug-interaction studies.

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>).