Sinecatechins

The mode of action of Veregen 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.

• Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1) . Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses (1.2) .

• None None (4)contraindicated

• Veregen is to be applied three times per day to all external genital and perianal warts (2.1) . • Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts (2.1) . • Veregen is not for ophthalmic, oral, intravaginal, or intra-anal use (2.1) . 2.1 General Dosing Information Veregen is to be applied three times per day to all external genital and perianal warts. Apply about an 0.5 cm strand of the Veregen to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen. It is not necessary to wash off the ointment from the treated area prior to the next application. Veregen ® is not for ophthalmic, oral, intravaginal, or intra-anal use. 2.2 Treatment Period Treatment with Veregen should be continued until complete clearance of all warts, however no longer than 16 weeks. Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen has not been tested under these circumstances. • Veregen should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease (5) . • Use of Veregen on open wounds should be avoided (5) . • Avoid exposure of Veregen treated areas to sun/UV-light as Veregen has not been tested under these circumstances (5) .

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers. Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1.

8.1 Pregnancy Risk Summary There are no available data on Veregen use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, sinecatechins did not cause malformations, but did affect the developing fetus in the presence of maternal toxicity when given to pregnant rabbits and rats by intravaginal or systemic routes of administration during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of sinecatechins observed in the animal studies to the systemic exposure that would be expected in humans after topical use of Veregen. Data Embryo-fetal development studies were conducted in rats and rabbits using intravaginal and systemic routes of administration, respectively. Oral administration of sinecatechins during the period of organogenesis (gestational Days 6 to 15 in rats or 6 to 18 in rabbits) did not cause treatment-related malformations or effects on embryo-fetal development at doses of up to 1,000 mg/kg/day.

Metabolism

Systemic exposure to EGCg, EGC, ECg, and EC were evaluated following either topical application of Veregen to subjects with external genital and perianal warts (250 mg applied 3 times a day for 7 days) or following oral ingestion of green tea beverage (500 mL ingested 3 times a day for 7 days). Following topical application of Veregen, plasma concentration of all 4 catechins were below the limit of quantification (<5 ng/mL) on Day 1.

• Oct 31, 2006NDANDA021902Ani Pharms

1. 1Cellulitis611%
2. 2Application Site Pain59.4%
3. 3Drug Ineffective59.4%
4. 4Pain47.5%
5. 5Product Use Issue47.5%
6. 6Application Site Erythema35.7%
7. 7Erythema35.7%
8. 8Off Label Use35.7%
9. 9Application Site Discharge23.8%
10. 10Application Site Pruritus23.8%
11. 11Application Site Ulcer23.8%
12. 12Condition Aggravated23.8%
13. 13Genital Herpes23.8%
14. 14Haemorrhage23.8%
15. 15Hypersensitivity23.8%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Sinecatechins as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
  Active not recruiting · Phase 2 · Interventional · 360 enrolled · ECOG-ACRIN Cancer Research Group
  NCT04597359updated 2026-05-05
• Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
  Recruiting · Phase 3 · Interventional · 280 enrolled · Aresus Pharma GmbH
  NCT07137819updated 2025-08-22
• Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
  Completed · Phase 3 · Interventional · 108 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT04055142updated 2024-07-10
• Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
  Terminated · Phase 2 · Interventional · 32 enrolled · GTO Pharmaceutical, LLC
  NCT03682601updated 2022-07-27
• Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment
  Completed · Interventional · 42 enrolled · Icahn School of Medicine at Mount Sinai
  NCT02147353updated 2019-06-14
• Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
  Completed · Phase 4 · Interventional · 28 enrolled · University of Texas Southwestern Medical Center
  NCT02622568updated 2017-09-08
• Topical Green Tea Ointment in Treatment of Superficial Skin Cancer
  Completed · Phase 2 · Phase 3 · Interventional · 42 enrolled · Maastricht University Medical Center
  NCT02029352updated 2016-05-18
• 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
  Completed · Phase 1 · Interventional · 30 enrolled · MediGene
  NCT01490008updated 2012-04-19
• Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
  Unknown · Phase 3 · Interventional · 8 enrolled · Centre Hospitalier Universitaire de Nice
  NCT01222000updated 2010-10-18
• Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage
  Completed · Phase 4 · Interventional · 43 enrolled · MediGene
  NCT01082302updated 2010-09-08

Frequently asked questions

How does Sinecatechins work?

The mode of action of Veregen 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.

What is Sinecatechins used for?

According to FDA labeling, Sinecatechins carries indications including: Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1) . Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses (1.2) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sinecatechins?

Sinecatechins is classified as Antivirals.

What are the brand names for Sinecatechins?

Sinecatechins is marketed under brand names including Veregen.

What are the contraindications for Sinecatechins?

Sinecatechins labeling lists contraindications including: None None (4). Always consult the full prescribing information and a clinician.