Piceatannol Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

A Phase 1 open-label clinical trial is evaluating the safety and pharmacokinetics of a modified derivative, glycolic acid tetrasubstituted piceatannol, administered via single intravenous infusion for Acute Respiratory Distress Syndrome (ARDS). Sponsored by the Gamaleya Research Institute of Epidemiology and Microbiology under the Health Ministry of the Russian Federation, the study commenced in late 2023. The trial's current recruitment status remains unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06127381	UNKNOWN	Acute Respiratory Distress Syndrome (ARDS)	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation	2023-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-11-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piceatannol selectively binds to spleen tyrosine kinase (Syk) and competes for substrate binding sites, thereby blocking downstream signaling cascades including IκB kinase activation, NF-κB-mediated gene expression, and intracellular inositol phosphate production to promote apoptosis and inhibit inflammatory cell responses. By suppressing Syk-driven pro-inflammatory signaling and cellular activity, this inhibitor provides a mechanistic rationale for reducing pathological lung tissue injury in conditions such as Acute Respiratory Distress Syndrome (ARDS).

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>).