Decursin Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 270

Clinical Trials

A completed early phase 1 clinical trial, sponsored by Texas Tech University Health Sciences Center, evaluated the natural pyranocoumarin compound Decursin in healthy adult men and women. The study assessed the single-dose oral pharmacokinetic properties and systemic exposure of Decursin alongside decursinol angelate. By establishing baseline human absorption and metabolism data, this initial research provides essential foundational evidence to inform potential future therapeutic evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02114957	COMPLETED	Healthy	Texas Tech University Health Sciences Center	2013-01	EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2014-04-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Decursin interacts with key intracellular signaling mediators to block downstream oncogenic and pro-inflammatory cascades, thereby inhibiting cell proliferation and triggering apoptosis in tumor cells. Characterizing these cellular actions provides the mechanistic rationale for clinical trial evaluations of Decursin, where pharmacokinetic profiling in healthy volunteers helps define systemic exposure required for anti-cancer and anti-inflammatory activity.

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>).