Botanceutical Inc is a pharmaceutical company bridging the gap between botanical science and modern prescription
By leveraging the FDA’s specialized Botanical Drug IND pathway, we bring pharmaceutical rigor to nature's most potent compounds, ensuring safety, efficacy, and consistent quality for patients, to transforming high-potential herbal medicines into FDA-approved prescription botanical drugs.
Over the past decades, we have built a robust infrastructure to collaborate with herbal manufacturers worldwide. We handle the full spectrum of drug development:
Global Identification: We scout and select established Herbal Medicines and Traditional Chinese Medicine (TCM) products with proven historical efficacy.
Preclinical Validation: We conduct rigorous scientific studies to substantiate mechanisms of action and safety profiles.
Regulatory Execution: We manage the complex regulatory landscape, executing clinical trials and filing FDA Investigational New Drug (IND) applications to bring these products to the U.S. market.
Our research focuses on conditions where botanical complexity offers unique therapeutic advantages. Our current development pipeline includes:
Bridging Historical Efficacy with Modern Regulatory Standards
BP-01 is a sterile botanical injection derived from Sarracenia purpurea (Purple Pitcher Plant). With a safety and efficacy profile established over nearly a century of use, BP-01 represents a rare opportunity in the pharmaceutical market: a Grandfathered US Prescription Drug currently available to patients.
Historical Context & Current Status First utilized by Indigenous peoples of North America and adopted into U.S. medical practice in the 1930s, BP-01 predates the establishment of the FDA. It is currently available in the U.S. market as a prescription medication. However, due to its grandfathered status, it does not yet have an associated FDA-approved label, preventing active marketing and insurance coverage.
Real-World Evidence Despite marketing restrictions, BP-01 has maintained a consistent user base through physician referrals and patient advocacy. It is currently utilized for the management of various neuropathic pain conditions, administered via subcutaneous, intramuscular, or intra-articular injection.
Common "Word-of-Mouth" Applications:
Sciatic & Lumbar Pain: Managing lower back and leg nerve pain.
Cranial Neuralgias: Including Trigeminal and Occipital Neuralgia.
Peripheral Neuropathies: Such as Intercostal Neuralgia and Meralgia Paresthetica.
Future Development Botanceutical Inc. is preparing to modernize this asset. We are seeking investment to execute a Phase 3 Clinical Trial and file for a formal FDA NDA. Our goal is to secure approved indications, enabling full commercialization, insurance reimbursement, and broad patient access.
Target Indication: Nephrotic Syndrome Regulatory Status: Pre-IND (Phase 2a Ready)
BP-02 is a botanical drug candidate currently advancing through the US FDA Botanical Drug IND pathway. Having successfully completed rigorous testing abroad, BP-02 is positioned for immediate Phase 2 initiation in the United States upon regulatory clearance.
Development Stage We are currently finalizing the Investigational New Drug (IND) application for a Phase 2a Clinical Trial.
Submission Status: Targeted for [Insert Date, e.g., Q3 2024]
Accumulated Clinical & Scientific Data BP-02 is supported by a robust package of existing data, de-risking the U.S. regulatory pathway:
Preclinical Validation: Full suite of studies completed, including small animal safety and pharmacokinetics (dose absorption) profiling.
Human Safety (Phase 1): Two completed Phase 1 trials in healthy volunteers (conducted in China).
Proof of Concept (Phase 2): One completed Phase 2 clinical trial demonstrating efficacy signals (conducted in China).
