Liver Monitoring: Drug Induced Liver Injury (DILI)
DILI is the most frequent single cause of safety-related drug marketing withdrawals according to the FDA (1). More than 900 drugs are known to cause liver injury, and drugs account for 20-40% of all instances of fulminant hepatic failure (2). In oncology, certain class of drugs such as Immuno-checkpoint-inhibitors (ICI) tend to be 4 times more toxic than the standard chemotherapy agents. Regular liver monitoring for DILI is required for treatment with an ICI drug in oncology. Similarly, in the autoimmune disease space, such as in multiple sclerosis, BTK inhibitors, the most promising candidates, tend to be associated with a high rate of DILI (3), requiring regular liver enzyme monitoring. Even in the obesity drug space, some promising candidates tend to show unacceptable rate of DILI, resulting in their discontinuation (4). Currently, there is no device in the market that enables quantitative at-home test of primary DILI marker ALT. The Pelican device from FemtoDx offers the only solution for at-home ALT monitoring (5), making it possible to avoid hospital visits and hospital stays.
(1) FDA: Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation. https://www.fda.gov/media/116737/download
(2) FDA: Drug Induced Liver Injury Rank (DILIrank) Dataset: https://www.fda.gov/science-research/liver-toxicity-knowledge-base-ltkb/drug-induced-liver-injury-rank-dilirank-dataset
(3) Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis, https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-13-06-00-00-2996609
(4) Pfizer scraps daily weight loss pill after liver injury in one patient: https://www.cnbc.com/2025/04/14/pfizer-scraps-daily-weight-loss-pill-danuglipron.html
(5) Alanine aminotransferase assay biosensor platform using silicon nanowire field effect transistors: https://www.nature.com/articles/s44172-023-00057-4.pdf