Adial Pharmaceuticals Gains U.S. Patent for Genetic-Based Alcohol and Opioid Treatment

Adial Pharmaceuticals, Inc., a biopharmaceutical company focused on addiction treatment, announced the issuance of a significant patent on April 15, 2025. The United States Patent and Trademark Office granted patent number 12,274,692, which covers a new method for treating alcohol-related and opioid-related disorders through the use of AD04, a drug developed by Adial for genetically identified patients.

This patent fortifies Adial's intellectual property by detailing the use of AD04 as a precision medicine for individuals with specific genetic markers. The patent outlines a treatment method involving the administration of AD04 to patients exhibiting certain serotonin-related gene variations. These genetic profiles include specific genotypes such as HTR3A, HTR3B, and SLC6A4, along with the LL genotype of 5-HTTLPR and variants like rs1150226, rs17614942, and rs1176713. The patent also specifies genetic profiles that correlate with treatment effectiveness and the corresponding dosage regimens. For Alcohol Use Disorder (AUD), the patent covers a wide range of alcohol-related conditions, including those associated with alcohol use, such as anxiety, bipolar disorder, sexual dysfunction, sleep disorders, gambling disorders, and alcohol withdrawal.

Cary Claiborne, Adial Pharmaceuticals' Chief Executive Officer, expressed that the patent marks a crucial achievement for the company as it pursues its goal of providing targeted treatments for individuals with alcohol and opioid use disorders. By focusing on genetic markers linked to AD04 efficacy, Adial is pioneering a precision medicine approach for AUD that could significantly improve treatment outcomes. The company remains dedicated to advancing AD04 through clinical development and regulatory channels to meet the pressing need for effective, personalized addiction treatments.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing therapies for addiction and related disorders. Its leading investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist designed to treat Alcohol Use Disorder in heavy drinking patients. Recently, AD04 was examined in the ONWARD™ pivotal Phase 3 clinical trial, which aimed to assess its potential for treating AUD in patients with certain target genotypes identified through Adial's proprietary genetic test. The trial demonstrated promising results in reducing heavy drinking among participants without significant safety or tolerability issues.

Beyond AUD, AD04 is also believed to hold potential for treating other addictive disorders, such as Opioid Use Disorder, gambling, and obesity. Adial Pharmaceuticals continues to focus on the development of AD04, as well as other innovative treatments, to address the urgent needs in the field of addiction therapy.