Tetrandrine Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 317

Clinical Trials

Multiple clinical trials evaluate the therapeutic application of tetrandrine across diverse inflammatory, autoimmune, and respiratory conditions, primarily focusing on Phase 4 protocols. Key indications under investigation include COVID-19, interstitial lung disease, connective tissue disease-associated interstitial lung disease, and rheumatoid arthritis. Led by academic medical institutions and regional hospitals, recruitment statuses vary from actively recruiting for lung disease evaluations to unknown or withdrawn for COVID-19 and combination therapy studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07319598	RECRUITING	Interstitial Lung Disease (ILD); Connective Tissue Disease-associated Interstitial Lung Disease	Peking University Third Hospital	2023-11-02	PHASE4
NCT05697029	WITHDRAWN	COVID-19	Peking University Third Hospital	2023-12-31	PHASE4
NCT05245448	UNKNOWN	Rheumatoid Arthritis	Peking University People's Hospital	2022-02-22
NCT04308317	UNKNOWN	Corona Virus Disease 2019,COVID-19	Henan Provincial People's Hospital	2020-03-05	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-01-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetrandrine functions as a calcium channel blocker that alters cytoskeleton distribution and induces p21 expression while inhibiting cyclin D1 and activating caspase-3, leading to cell cycle arrest, apoptosis, and suppression of mast cell degranulation. These anti-inflammatory, immunomodulatory, and antiproliferative downstream effects provide the biological rationale for its clinical investigation in inflammatory and respiratory disorders, including rheumatoid arthritis, interstitial lung disease, and 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>).