Loxoprofen Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

A completed Phase 1 clinical trial sponsored by AstraZeneca evaluated loxoprofen in healthy volunteers to assess its pharmacokinetics and potential drug-drug interactions with esomeprazole. This single-center, randomized cross-over study focused on early-phase safety, tolerability, and pharmacological compatibility upon repeat dosing rather than specific disease indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00676117	Completed	Healthy	AstraZeneca	2008-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Loxoprofen acts as a prodrug that is bioactivated to its active trans-alcohol metabolite, which binds and non-selectively inhibits cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2) to block the conversion of arachidonic acid into pro-inflammatory prostaglandins. This suppression of prostaglandin biosynthesis attenuates peripheral inflammatory cascades and nociceptive signaling, providing anti-inflammatory and analgesic efficacy and supporting its clinical evaluation for pharmacokinetic drug-drug interactions in healthy volunteers.

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>).