Identification
- Summary
Sinecatechins is a topical agent used to treat external genital and perianal warts in immunocompetent adult patients.
- Brand Names
- Veregen
- Generic Name
- Sinecatechins
- DrugBank Accession Number
- DB01266
- 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.
- Type
- Small Molecule
- Groups
- Approved, Investigational, Nutraceutical
- Synonyms
- CAMELLIA SINENSIS LEAF CATECHINS
- Kunecatechins
- Polyphenon E
- Sinecatechins
Pharmacology
- Indication
For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Condylomata acuminata •••••••••••• Treatment of Perianal warts •••••••••••• - Contraindications & Blackbox Warnings
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The mode of action of Sinecatechins (as ointment) involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.
- Mechanism of action
While the exact mechanism of action of catechins is unknown, they are powerful anti-oxidants and are linked to to evidence of fighting tumors as well as enhancing immune system function.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
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Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Veregen Ointment 10 % w/w Topical Paladin Labs Inc 2014-07-04 Not applicable Canada 
Veregen Ointment 150 mg/1g Topical PharmaDerm a division of Fougera Pharmaceuticals Inc. 2007-12-14 2024-11-29 US 
Veregen Ointment 150 mg/1g Topical ANI Pharmaceuticals, Inc. 2022-11-10 Not applicable US
Categories
- ATC Codes
- D06BB12 — Sinecatechins
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- T432289GYZ
- CAS number
- 188265-33-0
- InChI Key
- Not Available
- InChI
- Not Available
- IUPAC Name
- Not Available
- SMILES
- Not Available
References
- General References
- Not Available
- External Links
- PubChem Substance
- 46506183
- 753346
- PharmGKB
- PA164749508
- Wikipedia
- Sinecatechins
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Perianal Warts / Warts, Genital 1 4 Completed Treatment Verruca (Warts) 1 3 Completed Treatment Condylomata Acuminata 1 3 Unknown Status Treatment High Grade Anal Intraepithelial Neoplasia 1 3 Unknown Status Treatment Lamellar Ichthyosis 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Doak Dermatologics
- Dosage Forms
Form Route Strength Ointment Cutaneous 10 % Ointment Topical 10 % w/w Ointment Topical 150 mg/1g Ointment Cutaneous 100.0 mg - Prices
Unit description Cost Unit Veregen 15% ointment 19.86USD g DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US5795911 No 1998-08-18 2020-10-31 US US5968973 No 1999-10-19 2017-04-10 US US7858662 No 2010-12-28 2026-10-02 US US9770406 No 2017-09-26 2025-07-12 US US10434059 No 2019-10-08 2022-11-18 US
Properties
- State
- Solid
- Experimental Properties
- Not Available
- Predicted Properties
- Not Available
- Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
- Chromatographic Properties
Collision Cross Sections (CCS)
Not Available
Drug created at May 16, 2007 20:06 / Updated at April 18, 2024 09:15