About FDA
Evaluation of Cannabinoid Toxicity using Alternative Models
Description: Despite the increased use of cannabidiol (CBDs) and other cannabinoids such as cannabichromene (CBC), cannabigerol (CBG), and cannabinol (CBN), little research addressing the safety of use of these products exists, particularly the non-CBD cannabinoids (NCC). The goal of the proposed study is to screen NCC for any toxicity effects on different organs (e.g., hepatotoxicity, renal, reproductive and developmental toxicities), and evaluate our tools, which include in silico, in vitro (2D cell cultures, organ chips, and stem cell-derived hepatocytes), and non-vertebrate in vivo methods (C. elegans) to predict their potential organ toxicities; and compare to in vivo studies. This tiered strategy will rapidly screen these compounds for toxicity and select compounds for further testing. These studies will address some of the toxicology data gaps that exist in understanding the safety of CBDs and other cannabinoids such as CBC, CBG, CBN and non-CBD cannabinoids.
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
| 1. Conduct studies to predict adverse effects of cannabinoids using in silico modeling |
12/31/2023 (12/31/2022) |
On Track | |
| 2. Conduct in vivo studies to assess toxicity effects of cannabis extracts on the development and neuronal function in the non-vertebrate C. elegans |
12/31/2023 (6/30/2023) |
On Track | |
| 3. Conduct studies to assess hepatotoxic effects of cannabis extracts in in vitro in stem-cell derived liver cells |
12/31/2023 (6/30/2023) |
On Track | |
| 4. Conduct studies to assess hepatotoxic effects of cannabis extracts on hepatocyte viability, metabolism, and function using primary human hepatocytes, and liver-on-a-chip in vitro |
12/31/2023 (6/30/2023) |
On Track | |
| 5. Conduct studies to determine intestinal permeability and metabolism of cannabis extracts in differentiated Caco-2 cells in vitro |
12/31/2023 (6/30/2023) |
On Track | |
| 6. Conduct studies to determine metabolism of cannabis extracts in kidney cells using human renal proximal tubule cells in vitro using human renal proximal tubule cells in vitro |
8/31/2023 |
Canceled | |
| 7. Conduct studies to determine oromucosal absorption of cannabidiol (CBD) and other cannabinoid extracts from dietary supplements using an in vitro buccal cells assay |
12/31/2023 (6/30/2023) |
On Track | |
| 8. Compare results among the different cannabidiol (CBD) studies |
2/28/2024 (12/31/2023) |
Not Yet Started |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
