Cepharanthine Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Public clinical databases record a clinical trial evaluating the therapeutic potential of cepharanthine in individuals with asymptomatic COVID-19. Sponsored by the Shanghai Jiao Tong University School of Medicine, this completed Phase 2 study assessed the safety and efficacy of oral high-dose and low-dose regimens of the biscoclaurine alkaloid.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05398705	COMPLETED	Asymptomatic COVID-19	Shanghai Jiao Tong University School of Medicine	2022-05-31	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-08-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cepharanthine is a biscoclaurine alkaloid that inhibits tumor necrosis factor (TNF)-α-mediated activation of NF-κB, thereby blocking downstream signaling pathways and suppressing inflammatory cytokine production, lipid peroxidation, and platelet aggregation. This suppression of pro-inflammatory cascade signaling and cellular oxidative stress provides a mechanistic basis for its clinical evaluation in asymptomatic COVID-19.

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>).