Anserine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate conditions including knee osteoarthritis, pes anserine bursitis, and hyperuricemia, assessing applications ranging from metabolic regulation of serum uric acid to localized interventions for joint and bursal inflammation. Primarily sponsored by academic medical centers such as China Medical University Hospital, Cairo University, and the University of Alexandria, these Phase 2 and non-phased studies vary in recruitment status, encompassing completed, unknown, and not-yet-recruiting protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07286669	NOT_YET_RECRUITING	Knee Osteoarthritis	Cairo University	2025-12-15
NCT05385003	UNKNOWN	Subjects With Hyperuricemia	Sun Yat-sen University	2022-05-14
NCT05529914	COMPLETED	Knee Osteoarthritis; Pes Anserine Bursitis	Dow University of Health Sciences	2022-09-27
NCT04887844	COMPLETED	Osteoarthritis Knees Both	Abant Izzet Baysal University	2019-03-01
NCT04509440	COMPLETED	Anserine Bursitis	University of Alexandria	2018-05-01
NCT01205477	COMPLETED	Bursitis	Universidad Autonoma de Nuevo Leon	2009-09	PHASE2
NCT00208000	UNKNOWN	"Hyperuricemia,Anserine"	China Medical University Hospital	2004-07	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anserine functions as an imidazole dipeptide that buffers intracellular hydrogen ions and neutralizes reactive oxygen species, thereby inhibiting oxidative damage and modulating purine metabolic pathways. This biochemical regulation reduces cellular oxidative stress and limits purine catabolism, supporting its clinical evaluation for managing hyperuricemia and associated metabolic or joint disorders.

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>).