Paeonol Clinical Trials

Size	Price	Qty
200mg	USD 79
1g	USD 197

Clinical Trials

A Phase 2 clinical trial sponsored by AKL Research and Development evaluated a novel drug combination incorporating Paeonol and apocynin (APPA) for the treatment of knee osteoarthritis. Having completed recruitment, this industry-led study assessed the safety and symptom-relieving efficacy of the compound within a clinical population. Overall, clinical evaluation of Paeonol remains highly specialized, with research primarily directed toward alleviating pain and structural damage associated with degenerative joint disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04657926	COMPLETED	Osteoarthritis	AKL Research and Development	2020-09-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2021-11-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paeonol acts by inhibiting monoamine oxidase activity and suppressing pro-inflammatory signaling pathways, which subsequently reduces downstream cytokine secretion and cellular oxidative stress. This attenuation of inflammatory and nociceptive cascades mitigates joint tissue degradation and pain, establishing its pathophysiological relevance to the treatment of osteoarthritis.

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>).