Green Tea for Genital and Perianal Warts
The leaves of green tea are a source of medicinal compounds useful to general health and the treatment of specific ailments.
I know this wasn’t the direction you may have been expecting from me for a post on green tea, but hear me out! This is an incredible example of translational science and the development of a topical FDA-approved pharmaceutical agent for folks suffering from external genital and perinanal warts. In fact, VEREGEN® (sinecatechins) Ointment, a cocktail of sinecatechins (potent plant compounds found in green tea leaves) was the first ever drug to pass the approval of the FDA’s special “Botanical Drug” regulatory pathway (approved in 2006).
What is a Botanical Drug?
A botanical drug is distinct from a dietary supplement in several ways. A dietary supplement is a product taken by mouth and may include dietary ingredients such as vitamins, minerals, herbs, or extracts of plants. Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which specifies that they cannot include claims on the diagnosis or treatment of medical conditions.
A Botanical Drug, on the other hand, is intended for “use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.” The Food and Drug Administration (FDA) outlines the parameters of a botanical drug product to be:
A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof.
A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection.
Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products.
Importantly, the FDA requires that the drug be tested and subjected to the same level of rigor as any other FDA-approved drug. So far, only two botanical drug products have been approved for marketing as prescription drugs. One is sinecatechins, Veregen (a topical ointment for genital warts) and the other is crofelemer, Mytesi™, an oral therapy for non-infectious HIV-related diarrhea.
What Causes Genital Warts?
Genital warts, a common sexually transmitted infection, are caused by the human papillomavirus (HPV). There are different types of HPV (>80) and nearly all sexually active individuals likely to be infected at some point. Condoms can provide some protection against HPV transmission.
External genital warts typically manifest as small, skin-colored bumps on the moist tissues of the genital area, sometimes resembling cauliflower, though they can be too tiny to see. HPV strains differ in their effects; while some lead to genital warts, others may cause cancer. Vaccines are available to offer protection against certain strains of HPV.
What is Veregen®?
Veregen®, a 15% sinecatechin ointment derived from green tea leaves (Camellia sinensis), is the first botanical drug approved by the FDA for treating external genital warts, containing over 80% catechins and polyphenols. This is composed of a proprietary blend of eight different catechins and other green tea components, with epigallocatechin-3-gallate (EGCG) being the primary catechin at >55% and the other catechins including epicatechin , epigallocatechin (EGC), epicatechin gallate, gallocatechin gallate, gallocatechin, catechin gallate, and catechin.
These catechins are recognized for their anti-inflammatory, immunostimulatory, antiangiogenic, and antimicrobial properties. Clinical trials have demonstrated its effectiveness and tolerability as a self-applied treatment for genital warts, with common side effects limited to mild local reactions such as redness, itching, burning, pain, and skin erosion. One challenge to clinical implementation is that it is dosed three times a day, which can be a major barrier to patient compliance.
Interestingly, despite its well-documented efficacy in the treatment of external genital warts (EGW), the mechanism of action for sinecatechins (Veregen®) remains unknown.
The Takeaway
Veregen® is a great example of how a chemically complex botanical ingredient can be successfully developed into a prescription drug that meets the rigorous criteria of the FDA approval process. I’m excited about future opportunities for botanicals to be developed through this pathway.
Yours in health, Dr. Quave
Cassandra L. Quave, Ph.D. is a scientist, author, speaker, podcast host, wife, mother, explorer, and professor at Emory University School of Medicine. She teaches college courses and leads a group of research scientists studying medicinal plants to find new life-saving drugs from nature. She hosts the Foodie Pharmacology podcast and writes the Nature’s Pharmacy newsletter to share the science behind natural medicines. To support her effort, consider a paid or founding subscription, with founding members receiving an autographed 1st edition hardcover copy of her book, The Plant Hunter.
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