Asiaticoside Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate asiaticoside across diverse therapeutic indications, including apical periodontitis, dental tissue revascularization, overweight and obesity, idiopathic pulmonary fibrosis, pancreatic adenocarcinoma, and unruptured cerebral aneurysm. Encompassing Phase 2, combined Phase 2/3, and exploratory protocols, these studies are sponsored by academic and industry entities such as Mansoura University, Shanghai Zhongshan Hospital, Boehringer Ingelheim, and the University of Miami. Recruitment statuses across these investigations range from active recruiting and not yet recruiting to unknown and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07802340	RECRUITING	Revascularization of Immature Young Permenant Teeth	Mansoura University	2026-09-15
NCT07241533	RECRUITING	Overweight , Obesity	Shanghai Zhongshan Hospital	2025-12-01
NCT03814850	Withdrawn	Unruptured Cerebral Aneurysm	Sebastian Koch\|University of Miami	2024-12-01	Not Applicable
NCT05287347	Not yet recruiting	Pancreatic Adenocarcinoma	Beth Israel Deaconess Medical Center\|National Institutes of Health (NIH)\|Dana-Farber Cancer Institute	2024-10	--
NCT06360094	Not yet recruiting	Idiopathic Pulmonary Fibrosis\|Progressive Pulmonary Fibrosis	Boehringer Ingelheim	2024-07-27	Phase 2
NCT06566508	UNKNOWN	Intracanal Medication	Mansoura University	2023-11-20	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Asiaticoside suppresses ultraviolet A-induced reactive oxygen species generation and attenuates the DNA-binding activity of microphthalmia-associated transcription factor, thereby downregulating downstream pro-inflammatory signaling pathways and mitigating cellular oxidative damage. This anti-inflammatory and tissue-protective action provides the mechanistic foundation for its clinical investigation in managing dental inflammatory conditions, promoting endodontic revascularization, and treating pulmonary fibrosis and metabolic 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>).