Punicalagin Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 370

Clinical Trials

A completed Phase 4 clinical trial, sponsored by the academic research institution Instituto de Investigación Hospital Universitario La Paz, evaluated the therapeutic and physiological effects of punicalagin. The study investigated the modulation of cardiovascular disease-related inflammatory markers in healthy human subjects following the administration of a dietary mixture containing punicalagin and hydroxytyrosol. These findings clarify the systemic bioactivity and cardiovascular anti-inflammatory potential of this ellagitannin compound in healthy cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02042742	COMPLETED	Healthy	Instituto de Investigación Hospital Universitario La Paz	2013-04	PHASE4

(data from https://clinicaltrials.gov, updated on 2014-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Punicalagin functions as a potent polyphenolic antioxidant that scavenges reactive oxygen species and inhibits key pro-inflammatory signaling pathways, including nuclear factor-kappa B activation and downstream cytokine release. By dampening intracellular oxidative stress and downregulating pro-inflammatory cascades, punicalagin helps suppress systemic vascular inflammation, supporting its clinical evaluation for modulating cardiovascular disease-related inflammatory markers in healthy subjects.

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>).