Drugs / Sinecatechins
last change Mar 2026 re-read 9 days ago

Sinecatechins

Developed for
anogenital human papillomavirus infection · lung cancer · multiple sclerosis · precancerous condition · actinic keratosis · Barrett esophagus · breast cancer · colon adenocarcinoma
+16 more · colorectal adenoma · common wart · ductal breast carcinoma in situ · estrogen-receptor negative breast cancer · female breast carcinoma · intraepithelial neoplasia · non-small cell lung carcinoma · plasma cell neoplasm · progesterone-receptor negative breast cancer · prostate cancer · prostate carcinoma · skin basal cell carcinoma · ulcerative colitis · benign prostatic hyperplasia · sexual disorder · vulvodynia
Investigated by
National Cancer Institute (NCI) · MediGene · Louisiana State University Health Sciences Center Shreveport · British Columbia Cancer Agency · Louisiana State University Health Sciences Center in New Orleans · National Center for Complementary and Integrative Health (NCCIH)
+18 more · University of Cincinnati · Aresus Pharma GmbH · Barbara Ann Karmanos Cancer Institute · Charité Research Organisation GmbH · Columbia University · ECOG-ACRIN Cancer Research Group · Hospital Universitari Vall d'Hebron Research Institute · Maastricht University Medical Center · Mayo Clinic · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · Polyphenon E International,Inc. · Polyphenon Pharma · Sherry Chow · University of Chicago · University of Louisville · University of Texas Southwestern Medical Center · Will-Pharma

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) VEREGEN — 2007-12-19 fda.gov ↗
Approved US (FDA) VEREGEN — 2006-10-31 fda.gov ↗

Trials 22

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials · 2 met primary
Phase 1 NCT01490008 Dec 2011 → Mar 2012 anogenital human papillomavirus infection MediGene Completed No outcome recorded
Phase 1 NCT00836719 Feb 2009 → Nov 2010 multiple sclerosis Louisiana State University Health Sciences Center in New Orleans Completed Met primary
Phase 1 NCT00707252 Jan 2008 → Nov 2012 non-small cell lung carcinoma Louisiana State University Health Sciences Center Shreveport Terminated No outcome recorded
Phase 1 NCT00516243 Jul 2007 → Mar 2010 estrogen-receptor negative breast cancer, female breast carcinoma, progesterone-receptor negative breast cancer National Cancer Institute (NCI) Completed Met primary
Phase 1 NCT00233935 Nov 2005 → Nov 2010 Barrett esophagus National Cancer Institute (NCI) Completed No outcome recorded
Phase 211 trials · 1 met primary · 1 missed
Phase 2 NCT04597359 Oct 2021 → Dec 2026 expected prostate carcinoma ECOG-ACRIN Cancer Research Group Active not recruiting No outcome recorded
Phase 2 NCT01606124 Jun 2012 → May 2015 colon adenocarcinoma, colorectal adenoma Mayo Clinic Terminated Missed primary
Phase 2 NCT01451723 Jul 2011 → Feb 2013 multiple sclerosis Louisiana State University Health Sciences Center in New Orleans Terminated No outcome recorded
Phase 2 NCT01060345 May 2010 → Sep 2015 ductal breast carcinoma in situ University of Chicago Terminated No outcome recorded
Phase 2 NCT00942422 Nov 2009 → Mar 2012 plasma cell neoplasm, precancerous condition Barbara Ann Karmanos Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00718094 Mar 2008 → Oct 2011 ulcerative colitis University of Louisville Completed Met primary
Phase 2 NCT00573885 Jan → Nov 2008 lung cancer, nicotine dependence British Columbia Cancer Agency Completed No outcome recorded
Phase 2 NCT00611650 Oct 2006 → Jun 2011 lung cancer, precancerous condition, substance-related disorder British Columbia Cancer Agency Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00363805 May 2004 → Mar 2009 lung cancer Sherry Chow Completed No outcome recorded
Phase 2 NCT00676793 May 2004 → Dec 2009 breast cancer Louisiana State University Health Sciences Center Shreveport Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02029352 Nov 2014 → Sep 2015 skin basal cell carcinoma Maastricht University Medical Center Completed No outcome recorded
Phase 33 trials · 1 met primary · 1 missed
Phase 3 NCT07137819 Sep 2024 → Mar 2026 overdue actinic keratosis Aresus Pharma GmbH Recruiting No outcome recorded
Phase 3 NCT04055142 Sep 2020 → Jan 2024 intraepithelial neoplasia Hospital Universitari Vall d'Hebron Research Institute Completed Missed primary
Phase 3 NCT00449982 Jul 2003 → Aug 2004 anogenital human papillomavirus infection MediGene Completed Met primary
Phase 42 trials
Phase 4 NCT02622568 Jul 2015 → Jun 2016 common wart University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 4 NCT01082302 Jan → Aug 2010 anogenital human papillomavirus infection MediGene Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT03682601 Comparator Aug 2018 → Feb 2021 physiological sexual disorder, postmenopausal atrophic vaginitis, sexual disorder, vulvodynia GTO Pharmaceutical, LLC Terminated No outcome recorded
Phase 2 NCT00596011 Comparator Nov 2007 → Mar 2014 benign prostatic hyperplasia H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
— NCT02147353 Comparator Sep 2011 → Dec 2012 anogenital human papillomavirus infection Icahn School of Medicine at Mount Sinai Completed No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as sinecatechins “A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves)...” NCT07137819 ↗
7

“OBJECTIVE: To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts.” PMID 18515521 ↗ Jun 2008

“Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d)” NCT01490008 ↗

NCT03682601 ↗

NCT04597359 ↗

NCT04055142 ↗

NCT02029352 ↗

NCT02147353 ↗

Known as Camellia sinensis catechins ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗
Known as Camellia sinensis leaf catechins ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗
Known as defined green tea catechin extract “Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response...” NCT00573885 ↗
1

“Polyphenon E, a defined green tea catechin extract” NCT00611650 ↗

Known as EGCG “Our results show a significant reduction in serum levels of PSA, HGF, and VEGF in men with prostate cancer after brief treatment with EGCG (Polyphenon E), with no elevation of...” PMID 19542190 ↗ Jun 2009
Known as Green Tea Extract “Polyphenon E (Green Tea Extract)” NCT00676793 ↗
Known as Kunecatechins ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗
Known as POLYE “I. The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in...” NCT00233935 ↗
2

“We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor-negative breast cancer of an oral green tea extract, polyphenon E (Poly...” PMID 22827973 ↗ Jul 2012

“whether POLYE (Polyphenon E) treatment is associated with a significant percent decrease” NCT01606124 ↗

Known as Polyphenon E “Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response...” NCT00573885 ↗
16

“I. The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in...” NCT00233935 ↗

“Demonstrate the safety of green tea catechin extract (Polyphenon E) in women with a history of hormone receptor-negative breast cancer.” NCT00516243 ↗

“Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily” NCT00942422 ↗

“whether POLYE (Polyphenon E) treatment is associated with a significant percent decrease” NCT01606124 ↗

“Polyphenon E, a defined green tea catechin extract” NCT00611650 ↗

“Polyphenon E” NCT00516243 ↗

NCT00676793 ↗

NCT00836719 ↗

NCT00363805 ↗

NCT00596011 ↗

Show 6 more sources

Known as Veregen “Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d)” NCT01490008 ↗
2

“Polyphenon E (Veregen) 15% ointment” NCT01082302 ↗

NCT02622568 ↗

Action Inhibit “inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro” PMID 19542190 ↗ Jun 2009
Route Oral “Given orally” NCT00363805 ↗