Dihydromyricetin Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Several clinical trials are evaluating dihydromyricetin in Phase 1 and Phase 2 development, both currently reflecting an unknown recruitment status. Sponsored by academic institutions, including the University of Guadalajara and the University of Southern California, these studies target metabolic and hepatic indications such as type 2 diabetes mellitus and alcohol-related disorders. The research evaluates key outcomes including glycemic control, insulin sensitivity, and dose-escalation safety in alcohol-associated liver disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05623501	UNKNOWN	Alcohol-Related Disorders	University of Southern California	2024-09-15	PHASE1
NCT03606694	UNKNOWN	Type 2 Diabetes Mellitus	University of Guadalajara	2019-10-30	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dihydromyricetin acts as a natural antioxidant flavonoid that scavenges free radicals, thereby suppressing downstream oxidative stress cascades and mitigating inflammatory cellular damage. By reducing biomolecular oxidative stress and modulating metabolic pathways, this compound demonstrates therapeutic potential in improving insulin sensitivity in type 2 diabetes mellitus and protecting against hepatic tissue injury in alcohol-related 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>).