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Adial Pharmaceuticals Announces Publication of International PCT Patent Application to Protect Core Assets and Extend IP Exclusivity to at least 2045

January 14, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Adial Pharmaceuticals, addiction, alcohol use disorder, biopharma, clinical trials

New patent based on treatment of populations identified to be particularly responsive to ondansetron treatment after examination of Adial’s clinical data and information

14 January 2026 — Virginia, US — Adial Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced the publication of the international patent application for AD04, filed in July 2024. AD04 is the Company’s lead investigational genetically targeted serotonin-3 receptor antagonist therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 10 drinks/drinking day). The patent, once granted, is expected to protect Adial’s core assets through at least 2045.

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “As we continue to advance the AD04 program with planning for the next phase of our clinical program, the new patent application and its expected approval will extend protection of the core assets of Adial out to at least 2045. This application is the result of an extensive examination of data and information which occurred after Adial hired new patent counsel to bolster and leverage Adial’s intellectual property portfolio.”

About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.