Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic potential of (-)-epigallocatechin gallate (EGCG) across diverse indications, including malignancies (bladder cancer, plasma cell neoplasms), dermatological conditions (acne vulgaris, radiation dermatitis), and neurodegenerative or inflammatory disorders (Alzheimer's disease, traumatic brain injury, interstitial pneumonia). Conducted by major academic medical centers and national research institutes such as the National Cancer Institute, Mayo Clinic, and Seoul National University Hospital, these studies encompass various recruitment statuses—including completed, actively recruiting, terminated, suspended, and enrolling by invitation—to evaluate safety and efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06068543 SUSPENDED
Frailty; Inflammation
University of Rochester
 2024-10-25 PHASE2
NCT07647198 RECRUITING
Uterine Fibroids (Leiomyoma)
Sheikh Shakhbout Medical City
 2026-08-22 PHASE2
NCT06015022 RECRUITING
Cirrhosis, Liver
University of Texas Southwestern Medical Center
 2024-09-01 PHASE2
NCT07697196 NOT_YET_RECRUITING
HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix
IRCCS San Raffaele
 2026-07
NCT07344337 NOT_YET_RECRUITING
HPV Infection; Infertilities
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2026-03
NCT07320183 NOT_YET_RECRUITING
HPV - Anogenital Human Papilloma Virus Infection; Infertilities
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2026-03-01
NCT07578311 NOT_YET_RECRUITING
Postoperative Pain; Flare Up, Symptom; Flare up
Minia University
 2026-07
NCT07572396 RECRUITING
High-risk HPV (Any Strain); LSIL, Low Grade Squamous Intraepithelial Lesion; ASC-US; HPV Infection; Cervical Abnormalities; Uterine Cervical Dysplasia
Amplexd Therapeutics, Inc.
 2026-04-30 PHASE2
NCT07149506 ENROLLING_BY_INVITATION
Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin
CARLOS FRANCISCO SAAVEDRA GARCIA
 2025-09-01 PHASE3
NCT07754253 RECRUITING
Peridontitis
Mansoura University
 2026-03-16 PHASE1
NCT05195918 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
 2023-08-24 PHASE1
NCT07725900 COMPLETED
Hyperpigmentation; Dry Skin; Erythema
Naniek Widyaningrum
 2025-12-01 PHASE2; PHASE3
NCT06285357 RECRUITING
HPV Infection
Lo.Li.Pharma s.r.l
 2024-02-19
NCT06265532 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
 2024-02-07 PHASE1
NCT05811403 COMPLETED
Irreversible Pulpitis
Cairo University
 2023-07-01
NCT06661083 COMPLETED
HPV (Human Papillomavirus)-associated
AGUNCO Obstetrics and Gynecology Centre
 2024-08-01
NCT06524609 UNKNOWN
Chemotherapy-induced Peripheral Neuropathy
Han Xi Zhao
 2023-11-30 PHASE1; PHASE2
NCT02891538 COMPLETED
Colon Cancer
The University of Texas Health Science Center at San Antonio
 2017-01-31 EARLY_PHASE1
NCT06924749 COMPLETED
Pneumonia, Interstitial; Cancer Patients
Shandong Cancer Hospital and Institute
 2023-06-05 PHASE2
NCT06098456 COMPLETED
Papilloma-induced Cervical Lesions
Centro di Ricerca Clinica Salentino
 2023-11-01 PHASE2
NCT05758571 UNKNOWN
Interstitial Pneumonia; Neoplasms Malignant
Shandong Cancer Hospital and Institute
 2023-01-05 PHASE1; PHASE2
NCT05680662 UNKNOWN
Breast Cancer Female; Triple Negative Breast Cancer
Ministry of Health, Saudi Arabia
 2023-01-01 EARLY_PHASE1
NCT05039983 COMPLETED
Esophageal Obstruction
Shandong Cancer Hospital and Institute
 2021-08-20 PHASE1
NCT04553666 COMPLETED
Frailty; Inflammation
University of Rochester
 2021-04-28 PHASE2
NCT01744587 COMPLETED
NPC
National Health Research Institutes, Taiwan
 2013-04
NCT03978052 COMPLETED
Alzheimer Disease; Cognitive Decline
Parc de Salut Mar
 2019-10-30
NCT05758571 Recruiting
Interstitial Pneumonia|Neoplasms Malignant
Shandong Cancer Hospital and Institute
 2023-01-05 Phase 1|Phase 2
NCT02832271 COMPLETED
Endometriosis
Chinese University of Hong Kong
 2016-12-08 PHASE2
NCT05116098 UNKNOWN
Tuberculosis
Ministry of Health, Saudi Arabia
 2021-11-30 PHASE1
NCT01481818 UNKNOWN
Epigallocatechin Gallate; Radio Dermatitis; Radiation Mucositis
Shandong Cancer Hospital and Institute
 2011-09 PHASE1; PHASE2
NCT02577393 UNKNOWN
Lung Neoplasms; Esophagitis; Prevention & Control; Epigallocatechin Gallate
Shandong Cancer Hospital and Institute
 2015-04 PHASE2
NCT05349903 COMPLETED
Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2
Purdue University
 2021-11-10
NCT04177693 COMPLETED
Uterine Fibroids
Yale University
 2020-11-24 PHASE1
NCT03624556 COMPLETED
Down Syndrome; Fragile X Syndrome
Parc de Salut Mar
 2018-01-29
NCT02580279 UNKNOWN
Breast Neoplasms; Dermatitis; Prevention & Control; Epigallocatechin Gallate
Shandong Cancer Hospital and Institute
 2014-12 PHASE2
NCT03928847 COMPLETED
Idiopathic Pulmonary Fibrosis
Hal Chapman
 2017-12-01 EARLY_PHASE1
NCT01183767 COMPLETED
Duchenne Muscular Dystrophy
Charite University, Berlin, Germany
 2010-12-30 PHASE2; PHASE3
NCT02015312 COMPLETED
Light Chain (AL) Amyloidosis; Cardiac Involvement
Florian Michel
 2013-04 PHASE2
NCT02011451 WITHDRAWN
Multiple Sclerosis
Louisiana State University Health Sciences Center in New Orleans
 2015-12 PHASE2
NCT03194620 COMPLETED
Healthy
University of California, Davis
 2016-08
NCT02558933 COMPLETED
Fetal Alcohol Syndrome (FAS)
Fundacion Clinic per a la Recerca Biomédica
 2016-03
NCT02008721 COMPLETED
Multiple System Atrophy
Dr. Johannes Levin
 2014-01 PHASE3
NCT01511263 TERMINATED
Primary Amyloidosis of Light Chain Type
Fondazione IRCCS Policlinico San Matteo di Pavia
 2012-01 PHASE2
NCT00799890 COMPLETED
Multiple Sclerosis
Friedemann Paul
 2009-05 PHASE2; PHASE3
NCT00434499 WITHDRAWN
Hypertension; Obesity; Type 2 Diabetes; Insulin Resistance
University of Maryland, Baltimore
 2007-02 PHASE2
NCT02731495 COMPLETED
Traumatic Brain Injury
National Nutrition and Food Technology Institute
 2015-03 PHASE2; PHASE3
NCT01855971 COMPLETED
Fragile X Syndrome
Parc de Salut Mar
 2013-06-11 PHASE2
NCT01357681 COMPLETED
Huntington Disease
Charite University, Berlin, Germany
 2011-09 PHASE2
NCT00889434 COMPLETED
Cystic Fibrosis
Hadassah Medical Organization
 2011-11-01
NCT00951834 COMPLETED
Alzheimer's Disease
Charite University, Berlin, Germany
 2009-10 PHASE2; PHASE3
NCT01556321 COMPLETED
Obesity
Maastricht University Medical Center
 2012-06
NCT02147041 UNKNOWN
Diabetes Mellitus; Hyperlipidemia
Taipei City Hospital
 2012-05 PHASE2; PHASE3
NCT01433289 COMPLETED
HIV Infection
Baylor College of Medicine
 2010-12 PHASE1
NCT01699711 COMPLETED
Down Syndrome (DS)
Parc de Salut Mar
 2012-02 PHASE2
NCT02381145 COMPLETED
Healthy
Maastricht University Medical Center
 2012-08
NCT01662232 COMPLETED
Cardiovascular Diseases
Charite University, Berlin, Germany
 2012-08
NCT01846338 UNKNOWN
Acne Lesion Counts
National Yang Ming Chiao Tung University
 2012-10
NCT01018615 COMPLETED
Chronic Hepatitis C; Oxidative Stress
University of North Carolina, Chapel Hill
 2009-11 PHASE1
NCT00525668 COMPLETED
Relapsing-remitting Multiple Sclerosis
Charite University, Berlin, Germany
 2007-09 PHASE1; PHASE2
NCT01417312 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Charite University, Berlin, Germany
 2011-07
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
NCT01311869 TERMINATED
Leiomyoma
Meharry Medical College
 2010-12 PHASE2
NCT01394796 COMPLETED
Down Syndrome
Parc de Salut Mar
 2010-05 PHASE2
NCT00981292 COMPLETED
Cognitive Function; Mood
Northumbria University
 2009-08 PHASE4
NCT00867555 COMPLETED
Obesity; Type 2 Diabetes Mellitus
Maastricht University Medical Center
 2008-10
NCT00676780 COMPLETED
Prostate Cancer
Louisiana State University Health Sciences Center Shreveport
 2004-05 PHASE2
NCT01687556 COMPLETED
Acne Vulgaris
Seoul National University Hospital
 2005-07
NCT00153790 COMPLETED
Weight Loss
The Cooper Institute
 2005-04 PHASE1
NCT00461942 COMPLETED
Parkinson's Disease
Xuanwu Hospital, Beijing
 2006-04 PHASE2
NCT00611416 COMPLETED
Obesity
University of Copenhagen
 2005-11

(data from https://clinicaltrials.gov, updated on 2026-06-26)

Check the EGCG ((-)-Epigallocatechin Gallate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

EGCG directly binds to and inhibits key molecular targets including telomerase, DNA methyltransferase, EGFR, and HER-2 receptors, thereby blocking downstream oncogenic signaling cascades and suppressing aberrant cell proliferation. This multi-targeted biochemical inhibition promotes apoptosis and attenuates tissue inflammation, underlying its therapeutic relevance in clinical trials for bladder cancer, interstitial pneumonia, and radiation dermatitis.

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.