Clinical Trials
Numerous clinical trials have evaluated genistein in healthy volunteers and across diverse indications, including solid and hematologic malignancies (such as breast, bladder, non-small cell lung, and prostate cancers, leukemia, and lymphoma), Alzheimer's disease, and acute radiation syndrome. Spanning Early Phase 1 through Phase 4, these studies evaluate early-phase combination regimens alongside Phase 2 efficacy assessments. Sponsored by academic centers, industry, and government entities such as the United States Department of Defense, these trials display recruitment statuses ranging from recruiting and completed to terminated and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07785388 | NOT_YET_RECRUITING | HIV; Vascular Disease; Inflammation; Pain Management |
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
2026-09-30 | PHASE1; PHASE2 |
| NCT07385937 | NOT_YET_RECRUITING | Alzheimer Disease (AD); Mild Cognitive Impairment (MCI) |
Universidad Católica San Antonio de Murcia |
2026-02 | |
| NCT06689566 | RECRUITING | Myocardial Infarction (MI) |
National Taiwan University Hospital |
2025-09 | |
| NCT07033767 | NOT_YET_RECRUITING | Obesity; Children |
Western University |
2025-08-01 | PHASE1; PHASE2 |
| NCT06501768 | UNKNOWN | Heart Failure |
University Medical Centre Ljubljana |
2024-07-01 | PHASE1; PHASE2 |
| NCT07742501 | COMPLETED | Cognition; Mood |
University of Reading |
2024-11-01 | |
| NCT07742514 | COMPLETED | Cognition; Mood |
University of Reading |
2024-11-14 | |
| NCT06634108 | RECRUITING | Amyloid Cardiomyopathy |
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
2024-09-27 | PHASE1; PHASE2 |
| NCT06895954 | COMPLETED | Hyperlipidemia |
Shenzhen Hospital of Southern Medical University |
2024-10-13 | |
| NCT01489813 | COMPLETED | Bladder Cancer |
Emory University |
2017-05-19 | PHASE2 |
| NCT05073523 | Completed | Healthy |
Chalmers University of Technology |
2021-09-27 | Not Applicable |
| NCT02624388 | TERMINATED | Lymphoma; Childhood Lymphoma; Solid Tumor; Childhood Solid Tumor; Neuroblastoma; Ewing Sarcoma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Rhabdomyosarcoma; Soft Tissue Sarcoma; Medulloblastoma; Germ Cell Tumor; Wilms Tumor; Brain Neoplasms; Medulloblastoma, Childhood; Neuroectodermal Tumors, Primitive |
University of Virginia |
2016-08 | PHASE2 |
| NCT02766478 | TERMINATED | Prostate Cancer |
Emory University |
2017-10-16 | PHASE2 |
| NCT04650555 | Completed | Acute Radiation Syndrome |
Humanetics Corporation|United States Department of Defense|Joint Warfighter Medical Research Program |
2020-12-08 | Phase 1 |
| NCT01982578 | COMPLETED | Alzheimer's Disease |
Fundación para la Investigación del Hospital Clínico de Valencia |
2017-09-01 | |
| NCT02075112 | COMPLETED | Cancer of Head and Neck |
Emory University |
2013-11 | PHASE1 |
| NCT03040531 | UNKNOWN | Osteoporosis, Steroid Induced |
University of Messina |
2017-01-19 | PHASE2; PHASE3 |
| NCT04105023 | COMPLETED | Metabolic Syndrome; Obesity |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2013-09-15 | |
| NCT02499861 | COMPLETED | Cancer |
St. Justine's Hospital |
2015-07 | PHASE1; PHASE2 |
| NCT01982578 | Completed | Alzheimer''s Disease |
Fundación para la Investigación del Hospital Clínico de Valencia|University of Valencia |
2017-09-01 | Not Applicable |
| NCT01985763 | COMPLETED | Colon Cancer; Rectal Cancer; Colorectal Cancer |
Sofya Pintova |
2013-11 | PHASE1; PHASE2 |
| NCT02796794 | UNKNOWN | Sepsis |
TC Erciyes University |
2015-06 | PHASE4 |
| NCT02499861 | Completed | Cancer |
St. Justine''s Hospital |
2015-07 | Phase 1|Phase 2 |
| NCT01628471 | COMPLETED | Non Small Cell Lung Cancer |
Uman Pharma |
2012-11 | PHASE1; PHASE2 |
| NCT01325311 | COMPLETED | Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer |
National Cancer Institute (NCI) |
2011-12 | PHASE2 |
| NCT01538316 | UNKNOWN | Primary Prevention of Prostate Cancer |
University of Hohenheim |
2012-03 | |
| NCT01126879 | TERMINATED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer |
Northwestern University |
2011-02-03 | PHASE2 |
| NCT01628471 | Completed | Non Small Cell Lung Cancer |
Uman Pharma|DSM Nutritional Products Inc.|MDEIE Ministry Québec Government|INRS-Institut Armand Frappier Université du Québec |
2012-11 | Phase 1|Phase 2 |
| NCT01556737 | COMPLETED | Postmenopause |
Wageningen University |
2011-11 | |
| NCT00951912 | COMPLETED | Type 2 Diabetes Mellitus |
Sun Yat-sen University |
2009-08 | |
| NCT00541710 | COMPLETED | Metabolic Syndrome |
University of Messina |
2007-10 | PHASE2; PHASE3 |
| NCT00882765 | WITHDRAWN | Pancreatic Cancer |
Jonsson Comprehensive Cancer Center |
2009-05 | PHASE2 |
| NCT01664650 | COMPLETED | Metabolic Syndrome |
University of Messina |
2008-09 | PHASE2; PHASE3 |
| NCT00118040 | COMPLETED | Recurrent Bladder Carcinoma; Stage I Bladder Cancer AJCC v6 and v7; Stage II Bladder Cancer AJCC v6 and v7; Stage III Bladder Cancer AJCC v6 and v7 |
National Cancer Institute (NCI) |
2005-06-24 | PHASE2 |
| NCT00244907 | COMPLETED | Osteoporosis; Osteopenia |
Purdue University |
2006-01 | PHASE1 |
| NCT00376948 | COMPLETED | Pancreatic Cancer |
Barbara Ann Karmanos Cancer Institute |
2005-05 | PHASE2 |
| NCT00769990 | WITHDRAWN | Breast Cancer; Kidney Cancer; Lung Cancer; Melanoma; Metastatic Cancer; Pain; Prostate Cancer |
Masonic Cancer Center, University of Minnesota |
2008-09 | PHASE1; PHASE2 |
| NCT00290758 | COMPLETED | Breast Cancer |
National Cancer Institute (NCI) |
2006-01 | PHASE2 |
| NCT00698984 | COMPLETED | Osteoporosis |
dsm-firmenich Switzerland AG |
2007-01 | |
| NCT00590538 | TERMINATED | Cystic Fibrosis |
Children's Hospital of Philadelphia |
2003-02 | PHASE1; PHASE2 |
| NCT00453960 | COMPLETED | Endometrial Hyperplasia |
University of Messina |
2007-01 | PHASE2 |
| NCT00244933 | COMPLETED | Breast Cancer |
Barbara Ann Karmanos Cancer Institute |
2004-02 | PHASE2 |
| NCT00546039 | UNKNOWN | Prostatic Neoplasms |
University Hospital, Aker |
2007-04 | PHASE2 |
| NCT00276835 | COMPLETED | Kidney Cancer; Melanoma (Skin) |
Northwestern University |
2005-11 | EARLY_PHASE1 |
| NCT00058266 | TERMINATED | Prostate Cancer |
Northwestern University |
2002-12 | PHASE2 |
| NCT00269555 | COMPLETED | Prostate Cancer |
University of California, Davis |
2004-05 | |
| NCT00584532 | COMPLETED | Prostate Cancer |
University of California, Davis |
2003-11 | PHASE2; PHASE3 |
| NCT00016744 | COMPLETED | Cystic Fibrosis |
Children's Hospital of Philadelphia |
2001-09 | PHASE1; PHASE2 |
| NCT00099008 | COMPLETED | Breast Cancer; Endometrial Cancer |
UNC Lineberger Comprehensive Cancer Center |
2004-03 | PHASE1 |
| NCT01553773 | COMPLETED | Atrophy |
Federal University of São Paulo |
2004-07 | PHASE2 |
| NCT00287690 | COMPLETED | Coronary Artery Disease |
Imperial College London |
1999-10 | PHASE2; PHASE3 |
| NCT00005827 | WITHDRAWN | Prostate Cancer |
UNC Lineberger Comprehensive Cancer Center |
1999-12 | PHASE1 |
| NCT00004858 | UNKNOWN | Leukemia; Lymphoma |
Parker Hughes Cancer Center |
2000-03 | PHASE1 |
| NCT00000613 | COMPLETED | Bone Diseases; Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Ischemia; Osteoporosis; Postmenopause |
National Heart, Lung, and Blood Institute (NHLBI) |
1997-04 | PHASE2 |
| NCT00001696 | COMPLETED | Cancer |
National Cancer Institute (NCI) |
1998-04 | PHASE1 |
| NCT00355953 | COMPLETED | Menopause; Osteopenia |
University of Messina |
2003-01 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-08-25)
Check the
Genistein
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
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Note: Technical data last updated: Sep 1, 2026.