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Covid-19 Botanical Drug Clinical Development Phase I

Developing a known effective herbal medicine formula for early stage Covid19 infection to a prescription botanical drug.

The FDA's "Botanical Drug Development Guideline for Industry" relaxes the requirements and makes it possible for herbal medicines to be developed to prescription drugs in the United States: no longer requires identification of molecular structure, no longer requires description of mechanism of action, and allows a botanical drug product to be mixture of multiple plants.

【Covid-19 Botanical Drug】Project

The Covid-19 pandemic has made the world aware of advantages of herbal medicine. It is known that chemical drugs are lacking effectiveness in treating virus-induced infection. The left option to treat Covid-19 infection is vaccine. Due to rapid virus mutation, and the fact that vaccines are produced months ahead of deployment, vaccines cannot keep up with virus mutation and thus can not be fully effective. When a small percentage of population is infected by Covid-19 virus, the defense line intended by vaccines will collapse. Therefore, the focus of combating Covid-19 infection will be early stage treatment.

Several herbal medicines had shown effectiveness in treating Covid-19 infection in real world settings. It is estimated that the sales of Covid-19 medication in the US to be US$12.8B annual sale, and the global sales will exceed US$40 billion per year. Experts at the ABDA obtained one herbal formula and we intent to develop it to a prescription botanical drug through FDA botanical drug development pathway.

This project is for the clinical trial 1 development and is divided into two stages:

The first stage is to obtaining an IND number from FDA.

Then, the product moves to phase 1 clinical trial drug development:

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