Scutellarin Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 970

Clinical Trials

A clinical trial evaluates breviscapine powder-injection, an injectable formulation containing scutellarin, as a post-marketing observational registry to systematically monitor safety parameters, including adverse drug reactions, traditional Chinese medicine safety profiles, and acute anaphylactic reactions. Sponsored by principal investigators and institutions including Zhong Wang and the China Academy of Chinese Medical Sciences, the study has no designated formal trial phase. Currently, recruitment for this safety surveillance study is suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02559960	Suspended	Adverse Drug Event\|Adverse Drug Reaction\|Chinese Medicine\|Anaphylactic Reaction	Zhong Wang\|China Academy of Chinese Medical Sciences	2015-09	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Scutellarin modulates cellular signaling targets by downregulating STAT3/Girdin/Akt signaling and inhibiting RANKL-mediated MAPK and NF-κB pathways, which blocks downstream biochemical phosphorylation cascades to attenuate cellular proliferation and inflammatory mediator production. These multi-target anti-inflammatory and cellular anti-proliferative effects define its pharmacodynamic actions, establishing a essential mechanistic basis when evaluating clinical outcomes such as adverse drug events, anaphylactic reactions, and broader therapeutic safety in traditional Chinese medicine applications.

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>).