CLINICAL TRIALS PROFILE FOR VEREGEN

All Clinical Trials for Veregen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	Charité Research Organisation GmbH	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	Charité Research Organization GmbH	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	MediGene	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01222000 ↗	Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous	Unknown status	Centre Hospitalier Universitaire de Nice	Phase 3	2010-10-01	Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2). No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects. Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression. The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment. The secondary objectives - To estimate the duration of remission obtained after the treatment - To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement. - To estimate the action of cutaneous Veregen on the pruritus - And to estimate the global level of acceptability by the patient of the Veregen 10 %
NCT01490008 ↗	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	MediGene	Phase 1	2011-12-01	Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects. Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin exposure following dermal administration in the patient group will only be calculated if sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations. If applicable, a safety margin for ointment use might need to be established with respect to intolerable systemic exposures of catechins following application of Veregen® ointment. In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg three times daily: in the morning, at midday, and in the evening on the defined anogenital administration area (total dose of 750 mg/d) for one week . In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea beverage ("Lipton® Green Limone" distributed by PepsiCo Deutschland GmbH, Neu-Isenburg, Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500 mL/d) for one week. Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24 hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first dosing). To avoid any influence on overall systemic catechin exposure deriving from any other source than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages known to containing catechins (a list of all prohibited and allowed foods and beverages will be provided to all subjects). For concomitant medication, only paracetamol and oral contraceptives are allowed.

Clinical Trial Conditions for Veregen

Condition Name

Condition Name for Veregen
Intervention	Trials
Female Sexual Dysfunction	1
Vulvovaginal Atrophy	1
Genital Warts	1
Genito-Pelvic Pain/Penetration Disorder	1

Condition MeSH

Condition MeSH for Veregen
Intervention	Trials
Warts	4
Condylomata Acuminata	3
Atrophy	1
Vulvar Vestibulitis	1

Clinical Trial Locations for Veregen

Trials by Country

Trials by Country for Veregen
Location	Trials
United States	27
Germany	3
Netherlands	1
France	1
Guam	1

Trials by US State

Trials by US State for Veregen
Location	Trials
Texas	2
New York	2
Colorado	1
California	1
Arkansas	1

Clinical Trial Progress for Veregen

Clinical Trial Phase

Clinical Trial Phase for Veregen
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for Veregen
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for Veregen

Sponsor Name

Sponsor Name for Veregen
Sponsor	Trials
MediGene	2
University of Texas Southwestern Medical Center	1
GTO Pharmaceutical, LLC	1

Sponsor Type

Sponsor Type for Veregen
Sponsor	Trials
Other	8
Industry	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for VEREGEN

Last updated: October 29, 2025

Introduction

VEREGEN (sinecatechins 15%), developed by Golden Peach LLC, is a botanical therapeutic indicated primarily for the topical treatment of external genital and perianal warts caused by human papillomavirus (HPV) in immunocompetent adult patients. As one of the few phytotherapeutics sanctioned by the FDA for this indication, VEREGEN’s market trajectory hinges on ongoing clinical validation, competitive positioning, and regulatory developments. This report provides a comprehensive update on its clinical trial landscape, analyzes current market dynamics, and offers future projections based on emerging trends and data.

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Clinical Trials Landscape for VEREGEN

While VEREGEN received FDA approval in 2006, recent updates highlight the limited ongoing pivotal clinical trials. The drug's primary validation hinges on robust, evidence-based efficacy and safety profiles established during initial trials. However, the company has explored additional uses and combination therapies indirectly related to VEREGEN’s existing indication.

Regulatory and Post-Market Surveillance Activities

Post-approval, Golden Peach LLC has maintained vigilant pharmacovigilance, with periodic safety update reports (PSURs) submitted to regulators. No significant safety concerns have emerged since approval, reinforcing its safety profile for the approved indication.

Investigational Studies and Off-Label Developments

Currently, no large-scale, randomized controlled trials (RCTs) are underway to expand VEREGEN’s indications or optimize its formulation. Nonetheless, some smaller studies and observational research have examined the efficacy of sinecatechins in treating other HPV-related lesions, such as genital intraepithelial neoplasia, but these are not yet at the phase to influence regulatory status.

Emerging Trends Influencing Clinical Development

• Limited R&D Investment: Due to the niche market and FDA approval fulfilling specific needs, private investment into VEREGEN’s clinical pipeline remains modest.
• Interest in Natural Therapeutics: Growing consumer preference for botanical treatments might encourage further clinical validation, though no recent trials have been publicly announced.
• Regulatory Flexibility: The FDA's willingness to approve botanical drugs like VEREGEN under the botanical drugs pathway suggests potential in expanding the product’s indications with targeted trials, should new evidence emerge.

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Market Analysis

Current Market Position

VEREGEN operates in a specialized dermatological segment focused on genital wart treatment—predominantly a symptomatic management market. The drug's unique selling points include:

• Botanical Composition: Differentiates itself from chemical-based therapies.
• FDA Approval for HPV-Related Warts: Provides credible efficacy claims.
• Topical Application: Offers non-invasive, patient-friendly administration.

Market Size and Segments

The global genital warts market was valued at approximately USD 600 million in 2021, with an expected CAGR of around 3-4% through 2028, driven by increasing HPV prevalence and awareness campaigns. North America dominates, accounting for over 40% of the market share, with Europe and Asia-Pacific following.

Within this landscape, VEREGEN commands a niche segment favored by patients seeking botanical remedies, especially those with concerns over chemical-based treatments’ side effects.

Competitive Landscape

VEREGEN faces competition from other topical agents such as Imiquimod (Aldara), Podofilox, and cryotherapy. While Imiquimod remains the market leader due to broader indication approval and extensive data, VEREGEN's botanical nature appeals to a subset of patients and providers emphasizing natural treatments.

Regulatory and Reimbursement Factors

Coverage varies among insurers; in the United States, Medicare and Medicaid reimbursements are consistent with other topical treatments. However, price points and formularies impact market penetration.

Market Challenges and Opportunities

• Challenges: Limited indications restrict market expansion; substantial competition; relatively high cost compared to chemical therapies may limit adoption.
• Opportunities: Expanding indications into HPV-associated lesions, leveraging botanical branding, and patient preference shifts towards natural therapies could present growth avenues.

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Market Projections

Short-term Outlook (2023–2025)

Market growth will largely depend on:

• The stability of current demand.
• Adherence to safety profiles.
• Continued physician familiarity within the niche area.

Forecasts estimate modest annual growth, around 2-3%, maintaining its position as a niche therapeutic within HPV management.

Medium to Long-term Outlook (2025–2030)

Potential expansion hinges on:

• Conducting additional clinical trials to demonstrate efficacy in precursor lesions such as vulvar intraepithelial neoplasia or anal intraepithelial neoplasia.
• Development of combination therapies integrating sinecatechins with other agents for synergistic effects.
• Increasing consumer preference for natural remedies.

If trials demonstrate effectiveness in broader HPV-related conditions, VEREGEN could see market expansion, potentially doubling its current market size by 2030 in favorable scenarios.

Regulatory Pathways and Innovation

Applying for new indications via the FDA’s botanical drug pathway or pursuing orphan status for specific HPV-related lesions could accelerate market success. Additionally, exploring formulation improvements, such as combination with immunomodulators, may broaden therapeutic applicability.

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Conclusion and Key Takeaways

VEREGEN remains a niche but stable player within HPV wart management, primarily supported by its botanical origin and existing FDA approval. The clinical trial landscape is largely static, with no recent high-profile studies underway. Market growth is constrained by limited indications and stiff competition but has potential for expansion through targeted clinical research and shifting consumer preferences. The future success of VEREGEN will depend on strategic clinical trials, regulatory initiatives, and market positioning aligned with evolving healthcare trends favoring natural therapies.

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Key Takeaways

• VEREGEN's clinical validation history is robust but lacks recent large-scale trials aiming to expand its indications.
• The global HPV-related wart treatment market is growing modestly, with VEREGEN occupying a niche segment emphasizing botanical therapeutics.
• Market growth prospects are cautious but promising if new clinical evidence supports broader use.
• Strategic efforts to demonstrate efficacy in additional HPV-related lesions could unlock new revenue streams.
• Resource allocation toward clinical innovation and regulatory alignment will be critical to extend VEREGEN’s market relevance.

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FAQs

1. What are the primary clinical benefits of VEREGEN compared to conventional treatments for genital warts?
VEREGEN’s main advantage lies in its botanical formulation, offering a non-invasive, topical treatment with a well-established safety profile. Unlike chemical therapies, it may cause fewer local side effects and is preferred by patients seeking natural remedies.

2. Are there ongoing clinical trials investigating new uses for VEREGEN?
No publicly available large-scale or pivotal clinical trials are currently underway. Most recent research focuses on safety and efficacy within its approved indication.

3. What are the main barriers to expanding VEREGEN’s indications?
Barriers include limited clinical data beyond current approvals, competition from well-established treatments, and regulatory challenges associated with broadening botanical drug indications.

4. How does VEREGEN’s market share compare with its competitors?
While exact market share figures are proprietary, VEREGEN accounts for a small niche segment primarily driven by patients seeking natural treatment options, with Imiquimod being the dominant therapy due to broader approved indications.

5. What strategies could support VEREGEN’s growth in the coming years?
Investing in clinical trials targeting other HPV-related conditions, engaging with regulatory pathways to expand indications, and marketing emphasizing its botanical origins can bolster its market presence.

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References

1. Bloomberg, Global Genital Warts Market Analysis, 2022.
2. FDA, VEREGEN (Sinecatechins) Drug Approval Information, 2006.
3. MarketResearch.com, HPV Treatment Market Forecast, 2021.
4. Golden Peach LLC, VEREGEN Product Monograph, 2022.
5. Statista, Market Size of Genital Warts Treatments, 2022.