Numerous clinical trials spanning Early Phase 1 through Phase 2 evaluate the therapeutic potential and physiological impacts of equol, supported by pharmaceutical sponsors and academic institutions including Ausio Pharmaceuticals, the University of Colorado, Denver, and the Chinese University of Hong Kong. Research targets a broad spectrum of cardiovascular, neurological, and dermatological conditions, such as Alzheimer's disease, arterial stiffness, hypertension, chronic kidney disease, benign prostatic hyperplasia, and acne vulgaris. These studies range from completed and active trials in healthy individuals to recruiting protocols assessing vascular function, cognitive decline, and outcomes in childhood cancer survivors.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07194590 | RECRUITING | Chronic Kidney Disease (Stage 3-4); Vascular Function; Cognitive Functions; Cerebrovascular Function; Blood Pressure |
University of Colorado, Denver |
2026-02-19 | PHASE2 |
| NCT06128278 | RECRUITING | Chronic Kidney Diseases; Vascular Function; Women |
University of Colorado, Denver |
2023-03-07 | PHASE2 |
| NCT05741060 | ACTIVE_NOT_RECRUITING | Arterial Stiffness; White Matter Lesions; Cognitive Decline |
Akira Sekikawa |
2023-06-29 | PHASE2 |
| NCT07742501 | COMPLETED | Cognition; Mood |
University of Reading |
2024-11-01 | |
| NCT07742514 | COMPLETED | Cognition; Mood |
University of Reading |
2024-11-14 | |
| NCT03101085 | COMPLETED | Alzheimer Disease |
Russell Swerdlow |
2017-05-05 | PHASE1; PHASE2 |
| NCT04516304 | COMPLETED | Menopause |
Pharmavite LLC |
2019-03-27 | |
| NCT02352025 | COMPLETED | Breast Cancer |
The University of Texas Health Science Center at San Antonio |
2015-04-15 | EARLY_PHASE1 |
| NCT02515682 | UNKNOWN | Hypertension |
Chinese University of Hong Kong |
2015-10 | |
| NCT02142777 | COMPLETED | Alzheimer's Disease |
Russell Swerdlow, MD |
2014-07 | PHASE1 |
| NCT00962390 | COMPLETED | Benign Prostatic Hyperplasia |
Ausio Pharmaceuticals, LLC |
2009-06 | PHASE2 |
| NCT00962585 | COMPLETED | Menopause |
Ausio Pharmaceuticals, LLC |
2010-06 | PHASE2 |
| NCT01301586 | UNKNOWN | ACNE VULGARIS |
Nexgen Dermatologics, Inc. |
2010-11 | PHASE1; PHASE2 |
| NCT00998920 | COMPLETED | Healthy |
Ausio Pharmaceuticals, LLC |
2008-12 | PHASE1 |
| NCT00787007 | COMPLETED | Healthy |
Ausio Pharmaceuticals, LLC |
2008-09 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-02)
Mechanism and Biochemical Profile
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>).