Botanceutical Inc
a botanical drug company
Botanceutical Inc is an U.S-based botanical drug company committed to developing herbal medicines to U.S. prescrition drugs through the FDA's botanical drug IND pathway.
Over the past decades, Botanceutical Inc has been collaborated with herbal manufactures worldwide to:
identify herbal medicines and TCM products outside the U.S., such as skin infection, diabetics, weight loss, autoimmune disease, and oncology
conduct preclinical studies to support FDA IND applications
execute clinial trials and file FDA IND applications
Our mission is to expand therapeutic options in the pharmaceutical market to address unmet medical needs.
Product in Development
We currently have two major products undergoing the U.S. FDA IND process, with several others in the early stages of development.
BP-01
BP-01 is a grandfarthered botanical drug currently saled as US prescription drug in the U.S. It was first used by Indigenous peoples in North America, has been utilized for pain relief in the United States since the 1930s, predating the FDA's establishment. It is a botanical solution made from a single plant called Sarracenia Purpurea and is currently available as a prescription injectable medication in the US market.
Because BP-01 is a grandfarthered drug, there is no associated indication and FDA prohibits active marketing of this product. The current sale's volumn is about US$2M/year, through word-by-mouth among patients, paid by patients, and orderred by doctors to treat:
Sciatic Pain
Intercostal Neuralgia
Alchoholic Neuritis
Occipital Neuralgia
Brachial Plexus Neuralgia
Meralgia Paresthetica
Lumbar Neuralgia
Trigeminal Neuralgia
Route of Administration:
Subcutaneous
intramuscular
intra-articular administration
Investment Needs:
US$50M to conduct 1 phase 3 clinical trial. Product equity will be allocated to investors based on the amount of investment
File NDA to gain FDA approval
With approved indications, we plan to activly market this product and seek insurance coverages. The projected revenue is >US$1B/year
BP-02
Category: BP-02 is a botanical drug product in the US FDA botanical drug IND process
Development Stagte: about to submit phase 2a IND
Submission Date: Sep 30, 2024, expected
Indication: nephrotic syndrome
Accumulcated Data:
full precloinical studies: small animal safety studies, dose abosorption studies
2 phase 1 clinical trials in health Chinese volunteers (conducted in China)
1 phase 2 clinical trial (conducted in China)
Investment Needs if FDA' Grands Approval to start phase 2, to exchange for product equity:
US$7M to complete 1 phase 2 clinical trial study
US$500K to develop the phase 2 study report and file a phase 3 IND regulatory submission
US$30M to complete 1 phase 3 clinical trial study