Clinical Trials

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major universities, and specialized research institutes, the trials encompass completed, active, terminated, and withdrawn recruitment statuses.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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(+)-Catechin functions as an antioxidant flavonoid that scavenges reactive oxygen species and inhibits pro-inflammatory cascades, thereby mitigating downstream lipid peroxidation and suppressing cell stress pathways. By preserving mitochondrial function and attenuating oxidative damage, (+)-catechin demonstrates anti-proliferative and cytoprotective effects directly applicable to clinical trials in bladder cancer, cirrhosis, and muscular disorders.

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.