Oridonin Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A completed Phase 4 clinical trial sponsored by Union Hospital at Tongji Medical College of Huazhong University of Science and Technology evaluated Oridonin following percutaneous coronary intervention. The study assessed cardiovascular inflammatory responses and key biomarkers, specifically focusing on NLRP3 inflammasome pathway inhibition and high-sensitivity C-reactive protein (hsCRP) levels in post-procedure patients. This academic effort underscores the potential utility of Oridonin in managing acute inflammatory complications associated with coronary procedures.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05130892	COMPLETED	NLRP3; hsCRP; Percutaneous Coronary Intervention	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	2021-11-15	PHASE4

(data from https://clinicaltrials.gov, updated on 2023-02-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oridonin directly inhibits AKT1 and AKT2 kinase activity and suppresses the NLRP3 inflammasome, which blocks downstream pro-inflammatory cell signaling cascades and promotes apoptotic cell death. By suppressing these inflammatory cascades, Oridonin attenuates acute vascular damage responses, which provides therapeutic relevance for lowering high-sensitivity C-reactive protein levels and dampening NLRP3-mediated inflammation in patients following percutaneous coronary intervention.

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>).