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
  • Kunecatechins
  • Sinecatechins

Pharmacology

Indication

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

Pharmacology
Reduce drug development failure rates
Build, train, & validate machine-learning models
with evidence-based and structured datasets.
See how
Build, train, & validate predictive machine-learning models with structured datasets.
See how
Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
Avoid life-threatening adverse drug events
Improve clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.
Learn more
Avoid life-threatening adverse drug events & improve clinical decision support.
Learn more
Pharmacodynamics

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
Adverseeffects
Improve decision support & research outcomes
With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.
Learn more
Improve decision support & research outcomes with our structured adverse effects data.
Learn more
Toxicity

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

Products2
Drug product information from 10+ global regions
Our datasets provide approved product information including:
dosage, form, labeller, route of administration, and marketing period.
Access now
Access drug product information from over 10 global regions.
Access now
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
VeregenOintment150 mg/1gTopicalPharmaDerm a division of Fougera Pharmaceuticals Inc.2007-12-142024-11-29US flag
VeregenOintment10 % w/wTopicalPaladin Labs Inc2014-07-04Not applicableCanada flag

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
PubChem Substance
46506183
RxNav
753346
PharmGKB
PA164749508
Wikipedia
Sinecatechins

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentPerianal Warts / Warts, Genital1
4CompletedTreatmentVerruca (Warts)1
3Not Yet RecruitingTreatmentHigh-grade Anal Intraepithelial Neoplasia1
3Unknown StatusTreatmentLamellar Ichthyosis1
2RecruitingPreventionProstate Cancer1
2TerminatedTreatmentArousal Disorders, Sexual / Female Sexual Dysfunction (FSD) / Genito-Pelvic Pain/Penetration Disorder / Painful Intercourse / Postmenopausal Syndrome / Sexual Pain Disorders / Sexual; Disorder, Arousal, Female / Vestibulodynia / Vulvo Vaginal Atrophy / Vulvodynia1
2, 3CompletedTreatmentCarcinoma, Basal Cell (BCC)1
1CompletedTreatmentExternal Genital Warts1
Not AvailableCompletedTreatmentExternal Genital Warts1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • Doak Dermatologics
Dosage Forms
FormRouteStrength
OintmentCutaneous10 %
OintmentTopical10 % w/w
OintmentTopical150 mg/1g
Prices
Unit descriptionCostUnit
Veregen 15% ointment19.86USD g
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US5795911No1998-08-182020-10-31US flag
US5968973No1999-10-192017-04-10US flag
US7858662No2010-12-282026-10-02US flag
US9770406No2017-09-262025-07-12US flag
US10434059No2019-10-082022-11-18US flag

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

Drug created at May 16, 2007 20:06 / Updated at December 01, 2021 01:05