Baicalein Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 590

Clinical Trials

A clinical trial evaluating the therapeutic potential of oral Baicalein tablets is a Phase II investigation focused on treating viral respiratory infections, specifically influenza. Sponsored by the pharmaceutical company CSPC ZhongQi Pharmaceutical Technology Co., Ltd., the study assesses the clinical safety and efficacy profile of the compound in affected patient populations. Currently, the recruitment status for this Phase II trial is listed as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03830684	UNKNOWN	Influenza	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	2019-02-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2019-02-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Baicalein selectively inhibits cytochrome P450 2C9, prolyl endopeptidase, and specific lipoxygenases, thereby disrupting downstream arachidonic acid metabolism and inflammatory signaling cascades. By suppressing the production of pro-inflammatory eicosanoids and reducing cellular inflammatory responses, Baicalein provides therapeutic anti-inflammatory action that supports its clinical evaluation in patients with influenza.

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>).