Phloretin (RJC 02792) Clinical Trials

Size	Price	Qty
200mg	USD 147

Clinical Trials

A completed clinical trial evaluated the natural dihydrochalcone phloretin to assess dietary biomarkers and dose-response relationships in healthy human cohorts. Sponsored by Chalmers University of Technology, an academic institution, this randomized controlled trial designated formal pharmaceutical phases as not applicable due to its focus on nutritional biomarker validation. Overall, clinical data for phloretin currently remains centered on dietary biomarker evaluation rather than specific disease populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05073523	Completed	Healthy	Chalmers University of Technology	2021-09-27	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Phloretin (RJC 02792) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phloretin acts as a dihydrochalcone polyphenol inhibitor that targets cellular glucose transporters, thereby blocking intracellular glucose uptake and modulating downstream metabolic flux. This inhibition alters cellular energy homeostasis and glucose handling, providing a biochemical basis for evaluating metabolic dietary biomarkers and dose-response relationships in healthy clinical study participants.

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>).