Tanshinone IIA sulfonate sodium Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate sodium tanshinone IIA sulfonate for cardiovascular and pulmonary conditions. These include a Phase 4 trial sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine investigating left ventricular remodeling following acute myocardial infarction, as well as a Phase 2/Phase 3 trial sponsored by The First Affiliated Hospital of Guangzhou Medical University evaluating pulmonary arterial hypertension. Currently, the recruitment status for these registered trials is listed as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02524964	UNKNOWN	Left Ventricular Remodeling; Acute Myocardial Infarction	Guangdong Provincial Hospital of Traditional Chinese Medicine	2015-12	PHASE4
NCT01637675	UNKNOWN	Pulmonary Hypertension; Pulmonary Arterial Hypertension; Cardiovascular Diseases; Lung Diseases; Tanshinone IIA Sulfonate	The First Affiliated Hospital of Guangzhou Medical University	2013-05	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2016-09-01)

Check the Tanshinone IIA sulfonate sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium tanshinone IIA sulfonate acts as a negative allosteric modulator of the human purinergic P2X7 receptor and downregulates transient receptor potential canonical proteins, thereby inhibiting store-operated calcium entry through store-operated calcium channels. By suppressing intracellular calcium overload and downstream pro-inflammatory signaling, the compound mitigates pathological cellular stress and tissue remodeling, supporting its therapeutic potential in acute myocardial infarction and pulmonary arterial hypertension.

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>).