Tanshinone I Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several clinical trials evaluating tanshinone derivative interventions across Phase II, Phase III, and Phase IV focus on cardiovascular and pulmonary conditions, including acute myocardial infarction, left ventricular remodeling, pulmonary hypertension, and pulmonary arterial hypertension. Sponsored by academic and clinical medical centers such as the Guangdong Provincial Hospital of Traditional Chinese Medicine and The First Affiliated Hospital of Guangzhou Medical University, these registered studies currently report an unknown recruitment status.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tanshinone I suppresses tumor necrosis factor-alpha-mediated signaling pathways, thereby inhibiting the downstream expression of inflammatory cell adhesion molecules and inducing targeted cellular cytotoxicity. This attenuation of pro-inflammatory cell adhesion and cellular stress responses provides a therapeutic rationale for managing cardiovascular and pulmonary diseases such as left ventricular remodeling and pulmonary 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>).