Sinecatechins

Generic Name
Sinecatechins
Brand Names
Veregen
Drug Type
Small Molecule
Chemical Formula
-
CAS Number
188265-33-0
Unique Ingredient Identifier
T432289GYZ
Background

Sinecatechins is a botanical drug product for topical use. It is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.

Indication

For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Associated Conditions
Condylomata Acuminata, Perianal Warts
Associated Therapies
-

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring

First Posted Date
2020-10-22
Last Posted Date
2024-08-09
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
360
Registration Number
NCT04597359
Locations
🇺🇸

Bethesda North Hospital, Cincinnati, Ohio, United States

🇺🇸

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

🇺🇸

Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States

and more 350 locations

Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-12-12
Last Posted Date
2012-04-19
Lead Sponsor
MediGene
Target Recruit Count
30
Registration Number
NCT01490008
Locations
🇩🇪

CardioSec Clinical Reasearch GmbH, Erfurt, Germany

Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2011-10-14
Last Posted Date
2014-03-14
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Target Recruit Count
11
Registration Number
NCT01451723
Locations
🇺🇸

LSu Health Sciences Center, New Orleans, Louisiana, United States

Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-09-13
Last Posted Date
2023-05-19
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
23
Registration Number
NCT01433289
Locations
🇺🇸

University of Texas Health Science Center Houston, Houston, Texas, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-02-02
Last Posted Date
2020-04-09
Lead Sponsor
University of Chicago
Target Recruit Count
20
Registration Number
NCT01060345
Locations
🇺🇸

The University of Chicago, Chicago, Illinois, United States

Safety of Polyphenon E in Multiple Sclerosis Pilot Study

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-02-04
Last Posted Date
2013-06-27
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Target Recruit Count
10
Registration Number
NCT00836719
Locations
🇺🇸

Louisiana Health Sciences Center New Orleans, New Orleans, Louisiana, United States

Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2008-06-30
Last Posted Date
2015-04-21
Lead Sponsor
Louisiana State University Health Sciences Center Shreveport
Target Recruit Count
11
Registration Number
NCT00707252
Locations
🇺🇸

LSUHSC-Shreveport, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States

A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-05-13
Last Posted Date
2017-09-21
Lead Sponsor
Louisiana State University Health Sciences Center Shreveport
Target Recruit Count
32
Registration Number
NCT00676793
Locations
🇺🇸

LSU Health Sciences Center, Shreveport, Louisiana, United States

🇺🇸

Columbia Presbyterian Hospital, New York, New York, United States

Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-01-16
Last Posted Date
2019-10-04
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
97
Registration Number
NCT00596011
Locations
🇺🇸

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States

🇺🇸

Jefferson Medical College - Department of Urology, Philadelphia, Pennsylvania, United States

🇺🇸

University of Chicago - Department of Surgery, Chicago, Illinois, United States

and more 7 locations

Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

First Posted Date
2006-08-15
Last Posted Date
2013-11-28
Lead Sponsor
Sherry Chow
Target Recruit Count
178
Registration Number
NCT00363805
Locations
🇺🇸

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States

🇺🇸

Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States

🇺🇸

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea, Tucson, Arizona, United States

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