Madecassoside Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several clinical trials evaluate madecassoside across Phase 1, Phase 2, and non-phased studies for conditions including diabetic foot ulcers, skin anti-aging, post-procedural recovery in actinic keratoses, and sclerotic chronic graft-versus-host disease. Sponsored by diverse entities including Oneness Biotech Co. Ltd., Cosmetique Active International, Merete Haedersdal, and WeiShi, these investigations range from completed pharmacokinetic assessments to actively recruiting trials. Overall, these clinical efforts demonstrate a progression from topical tissue repair toward systemic management of complex inflammatory and fibrotic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07606703	RECRUITING	Chronic Graft-Versus-Host Disease; Graft vs Host Disease	WeiShi	2025-09-01	PHASE2
NCT05937529	COMPLETED	Actinic Keratoses	Merete Haedersdal	2023-09-27
NCT06059274	COMPLETED	Anti-aging	Cosmetique Active International	2018-03-14
NCT02353273	Completed	Diabetic Foot	Oneness Biotech Co. Ltd.	2015-07-22	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a principal active triterpene, madecassoside modulates pro-inflammatory signalling pathways by suppressing nuclear factor kappa B activation and inhibiting mitogen-activated protein kinase phosphorylation, thereby downregulating the cellular secretion of inflammatory cytokines and matrix metalloproteinases. This targeted inhibition of tissue degradation and localized inflammation promotes extracellular matrix assembly, providing the physiological basis for its therapeutic application in wound healing for diabetic foot ulcers, skin anti-aging therapies, and chronic graft-versus-host disease.

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>).