Clinical Trials

Multiple clinical trials evaluate daidzein across metabolic, endocrine, and cardiovascular conditions, encompassing Phase 2 and Phase 3 studies as well as non-interventional dietary evaluations sponsored primarily by academic research institutions. Target populations range from healthy individuals to postmenopausal women, with investigations targeting menopausal symptom relief, type 2 diabetes mellitus, hypertension, and metabolic dysfunction-associated steatotic liver disease. Recruitment statuses across these recorded trials span from completed studies to those that are not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07623044 NOT_YET_RECRUITING
Metabolic Dysfunction-Associated Steatotic Liver Disease
Eastern Hepatobiliary Surgery Hospital
 2026-05-21 PHASE2
NCT05073523 Completed
Healthy
Chalmers University of Technology
 2021-09-27 Not Applicable
NCT01556737 COMPLETED
Postmenopause
Wageningen University
 2011-11
NCT01270737 UNKNOWN
Hypertension
Chinese University of Hong Kong
 2011-03
NCT00951912 COMPLETED
Type 2 Diabetes Mellitus
Sun Yat-sen University
 2009-08
NCT00179556 COMPLETED
Menopausal Symptoms
Beth Israel Deaconess Medical Center
 2003-06 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a natural soy isoflavone phytoestrogen, daidzein acts as a peroxisome proliferator-activated receptor activator and binds estrogen receptors, modulating downstream transcriptional programs involved in lipid homeostasis, glucose metabolism, and antioxidant defenses. This metabolic and signaling regulation provides the physiological basis for its therapeutic potential in clinical trial conditions such as menopausal symptoms, type 2 diabetes mellitus, and metabolic dysfunction-associated steatotic liver 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>).

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Note: Technical data last updated: Sep 1, 2026.