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SINECATECHINS
The exact mechanism of action of sinecatechins in the treatment of genital and perianal warts is unknown, but it has demonstrated anti-oxidative activity in vitro.
Veregen (sinecatechins) is a topical ointment approved for treating external genital and perianal warts in immunocompetent adults aged 18 and older. Its mechanism of action is not fully understood, but it has shown anti-oxidative properties in vitro. Common side effects include local pain, erythema, and skin erosion. The drug is contraindicated in no specific conditions, and its safety and effectiveness have not been established in immunosuppressed patients or for treatments beyond 16 weeks.
At a glance
| Generic name | SINECATECHINS |
|---|---|
| Drug class | Polyphenols |
| Target | Unknown |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2006 |
Mechanism of action
In vitro studies suggest that sinecatechins have anti-oxidative properties, which may contribute to their therapeutic effect, although the clinical significance of this finding is not well understood.
Approved indications
Common side effects
- Local pain
- Erythema
- Vesicles
- Skin erosion/ulceration
- Phimosis
- Inguinal lymphadenitis
- Urethral meatal stenosis
- Dysuria
- Genital herpes simplex
- Vulvitis
- Hypersensitivity
- Pruritus
Key clinical trials
- To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring (PHASE2)
- Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis (PHASE3)
- 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 (PHASE3)
- Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment (PHASE2)
- Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment (NA)
- Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study (PHASE4)
- Topical Green Tea Ointment in Treatment of Superficial Skin Cancer (PHASE2, PHASE3)
- 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 (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7858662 | 2026-10-02 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SINECATECHINS CI brief — competitive landscape report
- SINECATECHINS updates RSS · CI watch RSS