Flurbiprofen Axetil Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials, including a Phase 4 and an unclassified study, are currently evaluating flurbiprofen axetil for postoperative pain management and analgesia in surgical settings such as thoracic surgery. Sponsored by academic hospital institutions, specifically Qilu Hospital of Shandong University and the First People's Hospital of Chenzhou, these recruiting and upcoming studies aim to assess the compound's efficacy in optimizing postoperative analgesia protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05901389	Not yet recruiting	Lidocaine\|Analgesia\|Pain Postoperative\|Thoracic Surgery	Qilu Hospital of Shandong University	2023-06	Not Applicable
NCT05622656	Recruiting	Pain Postoperative	First People''s Hospital of Chenzhou	2022-12-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flurbiprofen axetil functions as a nonselective inhibitor of cyclooxygenase enzymes, blocking the conversion of arachidonic acid into pro-inflammatory and pro-nociceptive prostaglandins. This reduction in prostaglandin biosynthesis diminishes peripheral sensory nerve sensitization, thereby demonstrating clinical efficacy in suppressing inflammation and managing postoperative pain.

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>).