Chrysin Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 497

Clinical Trials

According to current registry data, a completed clinical trial sponsored by Isura evaluated the bioavailability, safety, and pharmacokinetic profile of oral chrysin in healthy adult subjects. Conducted without a formal phase designation, the study compared distinct oral formulations of this natural flavone to characterize its systemic absorption and metabolic properties. These foundational findings establish critical parameters necessary to support the potential advancement of chrysin into targeted therapeutic applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07066839	COMPLETED	Bioavailability and Pharmacokinetics; Safety After Oral Intake	Isura	2024-12-05

(data from https://clinicaltrials.gov, updated on 2025-07-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chrysin functions as a bioactive flavone that suppresses cyclooxygenase-2 (COX-2) expression and interleukin-6 (IL-6) signaling cascades, thereby attenuating downstream pro-inflammatory mediator production and cellular inflammatory responses. Characterizing these anti-inflammatory pathway mechanisms provides a biochemical rationale for evaluating the systemic exposure, safety, and pharmacokinetic profile of oral chrysin formulations in clinical trials.

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>).