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3-(1-(cyclohexyl(methyl)carbamoyl)-1H-imidazol-4-yl)pyridine 1-oxide

An unanticipated severe neurologic disorder occurred after ingestion of BIA 10-2474 at the highest dose level used in a phase 1 trial,” said the NEJM report. “The underlying mechanism of this toxic cerebral syndrome remains unknown.”Neurology Today16 45 (2016)

In January 2016 an experimental study on a fatty acid amide hydrolase inhibitor of the type FIH, led to death of a healthy volunteer[1] A case of cummulative toxicity [2]

The molecule from Bial pharmaceutical company (Portela ca, Portugal) intended for enhancement of anandamide levels, its has a licking score (a formalin paw test) comparable to reference molecule gabapentine 300mg and 10 mg /Kg has a tail flick test maximum at 8 hour

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Guideline on strategies to identify and mitigate risks for 5 first-in-human and early clinical trials with investigational 6 medicinal products

Previous Article A Death and Other Adverse Events in French Drug Trial Raise Questions About Testing Safety and Ethics

Computational proteome-wide screening predicts neurotoxic drug-protein interactome for the investigational analgesic BIA 10-2474

Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase


  1. letter on access to the BIA 10-2474 clinical trial data
  2. Report by the Temporary Specialist Scientific Committee (TSSC), "FAAH (Fatty Acid Amide Hydrolase)", on the causes of the accident during a Phase 1 clinical trial in Rennes in January 2016.

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