PALO ALTO, Calif., Aug. 18, 2026 /PRNewswire/ — Amygdala Neurosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ANS-858, enabling the Company to advance ANS-858 into clinical development.

ANS-858 is Amygdala Neurosciences’ lead clinical candidate and a selective, reversible, orally bioavailable inhibitor of ALDH2. The Company plans to initiate a Phase 1 clinical trial designed to support the subsequent evaluation of ANS-858 across multiple indications in Phase 2 clinical trials.

“FDA clearance of our IND for ANS-858 represents an important milestone for Amygdala Neurosciences and our first-in-class ALDH2 therapeutic platform,” said Brent Blackburn, Ph.D., Chief Executive Officer of Amygdala Neurosciences. “Our research has demonstrated the important role of ALDH2 in pathological craving and led to the development of selective inhibitors designed to translate this biology into novel therapeutic approaches. Importantly, the therapeutic rationale for ALDH2 inhibition is supported by both human genetic and clinical evidence linking reduced ALDH2 activity with reduced alcohol consumption. With clearance of the IND, we look forward to advancing ANS-858 into clinical development and building upon this evidence.”