Policy & Regulation
Amygdala Neurosciences selects ANS-858 as lead clinical candidate for substance use disorder
3 April 2025 -

US biopharmaceutical company Amygdala Neurosciences Inc announced on Wednesday that it has selected ANS-858 as its lead candidate for clinical development as a novel ALDH2 inhibitor for substance use disorder.

ANS-858 is a new, proprietary, small molecule inhibitor of aldehyde dehydrogenase 2 (ALDH2). By inhibiting ALDH2, ANS-858 aims to reduce the rewarding effects associated with alcohol and other substances, thereby mitigating the risk of relapse and offering a path toward abstinence while also reducing anxiety.

The company said that the selection of ANS-858 follows an extensive preclinical evaluation demonstrating strong efficacy, selectivity and a favourable safety profile. ALDH2 inhibition represents a promising mechanism for reducing consumption of addictive drugs by affecting the mesolimbic dopamine reward pathway to reduce cravings. Compared with traditional therapies, ANS-858 is designed to provide greater tolerability, improved dosing flexibility and optimised pharmacokinetics.

Amygdala Neurosciences is planning to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) and progress ANS-858 into Phase 1 clinical trial.

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