Numerous clinical trials evaluate (+)-catechin and related green tea polyphenol formulations across diverse therapeutic areas, spanning Early Phase 1 through Phase 4 studies. These investigations address conditions such as bladder cancer, multiple myeloma, hepatic cirrhosis, influenza infection, and pulmonary arterial hypertension. Conducted by government agencies, major universities, and specialized research institutes, the trials encompass completed, active, terminated, and withdrawn recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06015022 | RECRUITING | Cirrhosis, Liver |
University of Texas Southwestern Medical Center |
2024-09-01 | PHASE2 |
| NCT07161726 | RECRUITING | Mobility Disability |
University of Alabama at Birmingham |
2026-04-21 | PHASE1; PHASE2 |
| NCT04300855 | ACTIVE_NOT_RECRUITING | Prostate Cancer; Prostate Adenocarcinoma |
H. Lee Moffitt Cancer Center and Research Institute |
2020-08-21 | PHASE2 |
| NCT04597359 | ACTIVE_NOT_RECRUITING | Prostate Carcinoma |
ECOG-ACRIN Cancer Research Group |
2021-10-05 | PHASE2 |
| NCT07149506 | ENROLLING_BY_INVITATION | Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin |
CARLOS FRANCISCO SAAVEDRA GARCIA |
2025-09-01 | PHASE3 |
| NCT06631820 | RECRUITING | Chronic Kidney Disease(CKD); Myosteatosis; Mitochondrial Dysfunction; Muscle Function; Muscle Mass |
Karolinska Institutet |
2025-01-17 | |
| NCT05811403 | COMPLETED | Irreversible Pulpitis |
Cairo University |
2023-07-01 | |
| NCT06107192 | COMPLETED | Healthy; Controlled Feeding Trial |
University of Maryland, College Park |
2023-12-07 | |
| NCT06604390 | COMPLETED | Elderly Individuals Aged 60 Years or Older; Mild Cognitive Impairment (MCI) |
Rahmi Novita Yusuf |
2024-02-01 | |
| NCT05988788 | COMPLETED | Necrotic Pulp |
Cairo University |
2023-10-01 | |
| NCT03278925 | UNKNOWN | Cirrhosis |
National Cancer Institute (NCI) |
2018-08-09 | PHASE1 |
| NCT05113498 | COMPLETED | Diet Modification |
University Ghent |
2021-11-01 | |
| NCT04386304 | COMPLETED | Becker Muscular Dystrophy |
Epirium Bio Inc. |
2020-07-13 | PHASE1 |
| NCT02490527 | COMPLETED | Statin Intolerance |
University of California, San Diego |
2015-06 | |
| NCT03826017 | COMPLETED | Cognitive Function |
Chonbuk National University Hospital |
2018-12-05 | |
| NCT03213340 | COMPLETED | Biological Aging |
Abbott Nutrition |
2017-09-14 | |
| NCT02660112 | COMPLETED | Friedreich's Ataxia |
Ralitza Gavrilova |
2016-09 | PHASE2 |
| NCT01856868 | COMPLETED | Becker Muscular Dystrophy |
Craig McDonald, MD |
2013-05 | PHASE1; PHASE2 |
| NCT03382067 | COMPLETED | Test Anxiety |
Prof. Dominique de Quervain, MD |
2017-12-04 | |
| NCT03214133 | COMPLETED | Collagen Synthesis |
University of California, Davis |
2017-05-23 | |
| NCT02964377 | COMPLETED | Duchenne Muscular Dystrophy |
Craig McDonald, MD |
2016-11 | PHASE1; PHASE2 |
| NCT03236662 | COMPLETED | Becker Muscular Dystrophy |
Craig McDonald, MD |
2016-11 | PHASE2 |
| NCT02015312 | COMPLETED | Light Chain (AL) Amyloidosis; Cardiac Involvement |
Florian Michel |
2013-04 | PHASE2 |
| NCT03194620 | COMPLETED | Healthy |
University of California, Davis |
2016-08 | |
| NCT02898571 | UNKNOWN | The Impact of Vitamin c and Epicatechin Upon Antioxidant Capactity |
Newcastle University |
2016-07 | |
| NCT02013856 | COMPLETED | Blood Pressure |
Quadram Institute Bioscience |
2014-07 | |
| NCT02656212 | COMPLETED | Pre-diabetes |
Veterans Medical Research Foundation |
2015-09 | PHASE1 |
| NCT00799890 | COMPLETED | Multiple Sclerosis |
Friedemann Paul |
2009-05 | PHASE2; PHASE3 |
| NCT02292342 | COMPLETED | Vasodilation |
University of Reading |
2014-05 | EARLY_PHASE1 |
| NCT02731495 | COMPLETED | Traumatic Brain Injury |
National Nutrition and Food Technology Institute |
2015-03 | PHASE2; PHASE3 |
| NCT02330276 | COMPLETED | Pre-diabetes |
Veterans Medical Research Foundation |
2014-09 | PHASE1 |
| NCT01606124 | TERMINATED | Advanced Colorectal Adenomas; Adenocarcinoma of the Colon; Stage I Colon Cancer; Stage II Colon Cancer; Stage III Colon Cancer |
Mayo Clinic |
2012-06 | PHASE2 |
| NCT02408289 | COMPLETED | Obesity |
Brooklyn College of the City University of New York |
2015-03 | |
| NCT02068040 | COMPLETED | Heart Failure |
University of California, San Diego |
2014-01 | |
| NCT01671514 | COMPLETED | Heart Failure; Type 2 Diabetes |
University of California, San Diego |
2012-07 | |
| NCT02221791 | COMPLETED | Endothelial Dysfunction; Bioavailability |
Wageningen University |
2014-06 | |
| NCT01880866 | WITHDRAWN | Pulmonary Arterial Hypertension |
University of California, San Francisco |
2013-07 | PHASE1 |
| NCT01585519 | COMPLETED | Cardiovascular Disease |
Queen's University, Belfast |
2012-04 | |
| NCT00253643 | COMPLETED | Precancerous Condition; Prostate Cancer |
OHSU Knight Cancer Institute |
2005-07 | |
| NCT00377507 | TERMINATED | Elderly |
Masahiro Morikawa |
2006-10 | |
| NCT01690676 | COMPLETED | Borderline Hypertension |
Danisco |
2012-08 | PHASE2 |
| NCT01018615 | COMPLETED | Chronic Hepatitis C; Oxidative Stress |
University of North Carolina, Chapel Hill |
2009-11 | PHASE1 |
| NCT01691404 | COMPLETED | Hypertension; Endothelial Dysfunction |
Wageningen University |
2012-09 | |
| NCT00666562 | COMPLETED | Stage I Bladder Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer |
National Cancer Institute (NCI) |
2008-07-02 | PHASE2 |
| NCT00942422 | TERMINATED | Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition |
Barbara Ann Karmanos Cancer Institute |
2009-11 | PHASE2 |
| NCT01490008 | COMPLETED | Anogenital Warts |
MediGene |
2011-12 | PHASE1 |
| NCT00611650 | TERMINATED | Lung Cancer; Precancerous Condition; Tobacco Use Disorder |
British Columbia Cancer Agency |
2006-10 | PHASE2 |
| NCT01097226 | COMPLETED | Healthy |
Quadram Institute Bioscience |
2010-04 | |
| NCT00303823 | COMPLETED | Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 1; Human Papilloma Virus Infection |
National Cancer Institute (NCI) |
2005-09 | PHASE2 |
| NCT00233935 | COMPLETED | Barrett Esophagus |
National Cancer Institute (NCI) |
2005-11 | PHASE1 |
| NCT01082302 | COMPLETED | Genital Warts; Perianal Warts |
MediGene |
2010-01 | PHASE4 |
| NCT00459407 | COMPLETED | Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer |
National Cancer Institute (NCI) |
2007-03 | PHASE1 |
| NCT01008020 | COMPLETED | Influenza Infection |
Masahiro Morikawa |
2009-11 | |
| NCT00516243 | COMPLETED | Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer |
National Cancer Institute (NCI) |
2007-07 | PHASE1 |
| NCT01969994 | COMPLETED | ADME |
The Institutes for Pharmaceutical Discovery, LLC |
2009-12 | |
| NCT00812448 | COMPLETED | Influenza Infection |
University of Shizuoka |
2008-12 | |
| NCT00944827 | COMPLETED | Hypercholesterolemia |
University of Thessaly |
2007-09 | PHASE2 |
| NCT00448513 | COMPLETED | Healthy |
University of Shizuoka |
2007-06 | |
| NCT00573885 | COMPLETED | Lung Cancer; Tobacco Use Disorder |
British Columbia Cancer Agency |
2008-01 | PHASE2 |
| NCT01340599 | TERMINATED | Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer |
Case Comprehensive Cancer Center |
2006-10 | PHASE2 |
| NCT00091325 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
University of Arizona |
2004-10 | PHASE1 |
| NCT00611416 | COMPLETED | Obesity |
University of Copenhagen |
2005-11 | |
| NCT00239213 | COMPLETED | Influenza Infection |
University of Shizuoka |
2005-11 |
(data from https://clinicaltrials.gov, updated on 2025-09-05)
Check the
(+)-Catechin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.