ADIL

Adial Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of alcohol use disorder (AUD). Headquartered in Charlottesville, Virginia, the company's primary asset is AD04, a genetically targeted therapeutic agent designed for patients with specific genetic markers associated with increased alcohol consumption. The company employs a precision medicine approach, utilizing a companion diagnostic test to identify patients most likely to respond to treatment based on their genetic profile. Adial completed its Phase 3 ONWARD clinical trial of AD04 in 2021, which evaluated the drug's efficacy in reducing heavy drinking days among AUD patients with certain serotonin transporter gene variants. In 2022, the company submitted a New Drug Application (NDA) to the FDA for AD04, marking a significant regulatory milestone. The AUD treatment market represents a substantial opportunity, with approximately 29 million Americans affected by the disorder according to recent estimates. Adial differentiates itself through its pharmacogenetic approach, targeting a specific patient population rather than pursuing a one-size-fits-all treatment strategy. The company continues to engage with regulatory authorities and prepare for potential commercialization activities while exploring partnership opportunities to maximize AD04's market potential.