Amygdala Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for ANS-858

ANS-858 is being developed to reduce pathological craving associated with alcohol and other substance use disorders.

Amygdala's ALDH2 inhibitor platform offers additional therapeutic opportunities in binge eating, obesity, and precision oncology.

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."

A New Approach

Amygdala Neurosciences has developed what it believes are the first and only known selective, orally bioavailable, once-daily inhibitors of ALDH2. The Company's first-in-class platform is protected by composition-of-matter intellectual property and is designed to provide multiple potential therapeutic opportunities by targeting ALDH2, which Amygdala has identified as an important regulator of pathological craving and disease biology.

ANS-858 is initially being advanced as a potential treatment for alcohol use disorder and other substance use disorders. By selectively and reversibly inhibiting ALDH2, Amygdala believes ANS-858 has the potential to reduce pathological craving, a major driver of substance use and relapse. Clinical proof of concept with ANS-858 would build upon existing human genetic and clinical evidence supporting ALDH2 inhibition and provide important validation of the Company's proprietary ALDH2 therapeutic platform.

The Company is also evaluating ANS-858 in compulsive eating disorders associated with binge eating and obesity, based on similarities between the biological mechanisms underlying pathological food craving and those involved in substance use disorders. ANS-858 has the potential to be developed as a once-daily oral therapy to reduce pathological food cravings and support long-term weight management, either as a standalone therapy or as an adjunct to GLP-1 receptor agonists.

Separately, Amygdala Neurosciences is evaluating its proprietary library of selective ALDH2 inhibitors in precision oncology, including as a potential therapeutic approach for colorectal cancers harboring APC mutations. APC is a tumor-suppressor gene that plays a central role in colorectal cancer biology. The Company estimates that APC mutations are present in approximately 70% of colorectal cancer cases, representing a large genetically defined patient population for evaluation of an ALDH2-targeted therapeutic approach.

Funding Acknowledgement

The discovery and development of ANS-858 have been supported, in part, by NIH grants R43AA029311 and U43AA030689 and by investment support from ABMRF/The Foundation for Alcohol Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About Amygdala Neurosciences

Amygdala Neurosciences, Inc. is a clinical-stage biotechnology company developing a proprietary platform of first-in-class, selective ALDH2 inhibitors for multiple therapeutic applications. The Company is led by an experienced team of scientist-entrepreneurs with a track record of developing and commercializing novel therapeutics, including Ranexa® and Lexiscan®. CEO Brent Blackburn, Ph.D., previously led Research and Development at CV Therapeutics and founded Rapiscan Pharma Solutions, which was acquired by GE Healthcare.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development and potential therapeutic applications of ANS-858 and Amygdala Neurosciences' ALDH2 inhibitor platform, including the initiation and conduct of clinical trials. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. ANS-858 is investigational and has not been approved by the FDA or any other regulatory authority. Amygdala Neurosciences undertakes no obligation to update these statements except as required by applicable law.

SOURCE Amygdala Neurosciences Inc.