Fraxinellone Clinical Trials

Size	Price	Qty
1mg	USD 107

Clinical Trials

A clinical trial sponsored by the University of Houston was established to evaluate the pharmacokinetic profile of this agent in healthy adults, although its phase is not explicitly defined and its recruitment status remains unknown. Consequently, human clinical data for this compound are limited to early pharmacokinetic evaluations, with no reported Phase 2 or Phase 3 efficacy studies in patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04230057	Unknown status	Healthy Adults	University of Houston	2019-12-12	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fraxinellone interacts with cellular inflammatory signaling cascades to suppress pro-inflammatory cytokine expression and downregulate NF-κB-mediated transcription, thereby reducing cellular oxidative stress and inflammatory damage. This attenuation of inflammatory mediator release underlies its neuroprotective and anti-inflammatory activities, providing the mechanistic rationale for evaluating its pharmacokinetic profile and safety in healthy adult subjects.

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>).