Equol Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Several clinical trials evaluate the therapeutic potential of Equol across metabolic, endocrine, and neurological conditions, focusing on non-alcoholic fatty liver disease, menopausal management, and Alzheimer's disease. These studies encompass Phase 1/2, Phase 2, and specialized protocols, with recruitment statuses ranging from actively recruiting to completed. Research efforts are conducted by both commercial sponsors like Ausio Pharmaceuticals LLC and academic medical centers, including the Children's Hospital Medical Center Cincinnati, the University of Valencia, and the University of Kansas Medical Center.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06133101	Recruiting	Non-Alcoholic Fatty Liver Disease	Marialena Mouzaki\|Children''s Hospital Medical Center Cincinnati	2024-01-15	Phase 2
NCT06398236	Recruiting	Menopause	Nutrition & Sante Iberia\|Adknoma Health Research	2023-03-17	Not Applicable
NCT01982578	Completed	Alzheimer''s Disease	Fundación para la Investigación del Hospital Clínico de Valencia\|University of Valencia	2017-09-01	Not Applicable
NCT03101085	Completed	Alzheimer Disease	Russell Swerdlow\|Ausio Pharmaceuticals LLC\|University of Kansas Medical Center	2017-05-05	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Equol is a soy-derived metabolite that specifically binds to 5α-dihydrotestosterone (5α-DHT) and selectively interacts with estrogen receptor ERβ, thereby modulating downstream androgenic and estrogenic signaling cascades to alter hormone-responsive cellular transcription. This multi-target endocrine modulation provides a direct mechanistic rationale for its clinical investigation in hormone- and metabolic-associated conditions, including menopause, non-alcoholic fatty liver disease, and Alzheimer's disease.

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>).