What are Botanical Drugs？
Botanical drugs are therapeutic materials derived from plants, plant extracts, algae, fungi, or other natural sources. These materials may come from a single plant or a combination of multiple plants. As per the regulations of the US FDA, the collective combination of these components is recognized as the active pharmaceutical ingredient (API) for a botanical drug.
Botanical Reference Standards
The botanical reference standards repository bank holds over 10,000 botanical ingredient standards with each precisely dosed at 20mg in vials and boasting a purity of HPLC≥98%. Those standards serve as an essential asset for the research and development in botanical and pharmaceutical fields.
While sharing similarities with traditional IND processes for small and large molecules, cell therapies, and gene therapies, botanical drug INDs have unique considerations. The FDA's Botanical Drug Development Guidance for Industry outlines a streamlined approach, exempting plant-derived products from the rigorous requirements of detailing molecular structure, mechanism of action, and specific active ingredients. However, botanical products must still undergo robust clinical trials to demonstrate safety and efficacy, aligning with the stringent standards for all prescription medications. Currently approved botanical drugs are Veregen, Fulyzaq/Mytesi,, NexoBrid, and Filsuvez.
The FDA's Botanical Drug Development Guidance for Industry provides clear and actionable direction for conducting botanical INDs. The limited number of botanical drug approvals may be attributed to the following factors:
1. The concept of "botanical drugs" is relatively new, and there has been insufficient investment in this area.
2. The guidance was introduced to the industry only in recent years, and developing a drug product typically takes more than a decade. Currently, many botanical drug candidates are in Phase 3 clinical trials.
3. Botanical drug APIs often involve full-spectrum extractions from plants. Quality control presents a challenge for chemists accustomed to working with single-molecule drugs.
