Adial's Patent Play: Securing a 2045 Horizon for its Genetic AUD Drug

GLEN ALLEN, VA – January 14, 2026 – Adial Pharmaceuticals has taken a significant step to secure the long-term future of its lead drug candidate, AD04, by announcing the publication of an international patent application. The move, if the patent is ultimately granted, is expected to extend intellectual property protection for the novel Alcohol Use Disorder (AUD) therapy to at least 2045. This strategic filing underscores the company's confidence in its genetically targeted approach and aims to create a durable competitive advantage in the multi-billion-dollar market for addiction treatments.

AD04 is an investigational therapeutic agent designed to treat AUD in patients with specific genetic markers. The publication of the Patent Cooperation Treaty (PCT) application, which was filed in July 2024, makes the company's claims public on an international stage and represents a critical milestone in its global commercial strategy.

“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,” stated Cary Claiborne, President and CEO of Adial. He noted that the application stemmed from a deep analysis of clinical data after the company engaged new patent counsel to fortify its intellectual property portfolio.

A Strategic IP Fortress

For a clinical-stage biopharmaceutical company like Adial, a robust intellectual property portfolio is paramount. While the active ingredient in AD04, ondansetron, is a well-known compound available in generic form for treating nausea, Adial's strategy hinges on patenting a specific method of use. This new PCT application is the latest pillar in a carefully constructed IP fortress designed to protect its unique therapeutic approach from competition.

Adial's patents do not cover the chemical ondansetron itself, but rather its application in a highly specific context: an ultra-low dose (0.33 mg) administered to AUD patients who possess certain genetic variations. This precision-medicine strategy is protected by a series of patents that create a high barrier to entry. For example, U.S. Patent No. 12,274,692, granted in April 2025, covers the method of treating alcohol-related disorders by administering AD04 to patients with specific genotypes related to serotonin receptors, such as HTR3A, HTR3B, and the serotonin transporter gene SLC6A4.

Another key patent, U.S. Patent No. 12,150,931, issued in late 2024, further broadened this protection by covering a wider range of genotype combinations identified by Adial's proprietary diagnostic test. By patenting the link between the genetic panel and the treatment protocol, Adial aims to prevent competitors from using ondansetron for this purpose without conducting their own extensive and costly clinical trials to validate a different genetic panel. The new international application seeks to solidify and extend this protection on a global scale for more than two decades, a crucial factor in attracting potential partners and securing long-term value.

Personalizing Addiction Treatment

The scientific foundation of AD04 represents a potential paradigm shift in how addiction is treated. For decades, the approach to AUD has largely been a one-size-fits-all model, with existing medications showing variable efficacy across the patient population. Adial is pioneering a personalized approach by targeting the underlying genetic predispositions that can influence drinking behavior.

AD04 is a serotonin-3 receptor antagonist that works by modulating the brain's reward pathways associated with alcohol consumption. The treatment is intended for patients identified by Adial's companion diagnostic test as being "biomarker positive for AG+." This genetic profile, estimated to be present in about one-third of the AUD patient population, is believed to make individuals particularly responsive to AD04's mechanism of action. The goal is to reduce the craving for and rewarding effects of alcohol, thereby decreasing heavy drinking days.

This genetically targeted strategy was validated in the company's ONWARD pivotal Phase 3 trial, which showed promising results in reducing drinking among heavy-drinking patients who had the target genotypes. The trial also demonstrated a favorable safety profile with no significant tolerability concerns. By identifying the right patient for the right drug, Adial hopes to deliver more consistent and superior outcomes than currently available therapies, addressing a significant unmet need in addiction medicine. The company also believes AD04 holds potential for treating other addictive disorders like Opioid Use Disorder, pathological gambling, and obesity, which could further expand its future market impact.

Navigating the Path to Market

With a fortified IP position, Adial is also making significant headway on the regulatory front. The company is actively planning a new Phase 3 clinical trial program designed in collaboration with Cytel Inc., a leader in advanced statistical trial design. This partnership has helped refine the trial's strategy to maximize its probability of success based on a deeper analysis of data from the ONWARD study.

A pivotal moment came in September 2025, when Adial received final minutes from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The agency provided what the company described as "favorable comments" and "constructive dialogue" regarding the proposed adaptive design for the upcoming Phase 3 trial. The FDA aligned with Adial on several critical design elements, including the use of "zero heavy drinking days during months 5 and 6" as the primary efficacy endpoint for the trial.

Furthermore, the FDA supported the plan to stratify patient populations based on their biomarker status and to pre-specify key secondary endpoints intended for the final product label. This regulatory clarity provides a well-defined path forward for Adial as it prepares to initiate the registrational trial. The alignment is expected to de-risk the clinical program and has already become a key catalyst in accelerating discussions with potential strategic partners who can help fund and execute the final stages of development and commercialization.

Investor Confidence and Partnership Potential

The combination of strengthening IP and regulatory progress has not gone unnoticed by the market. Following previous positive patent news in May 2025, Adial's stock (NASDAQ: ADIL) saw a significant surge as investors reacted to the de-risking of the company's lead asset. The latest patent filing is expected to further bolster investor confidence by demonstrating a clear, long-term strategy for value creation.

For a clinical-stage company with cash and equivalents of $4.6 million as of its last reporting, securing a strategic partnership is a critical next step. The extended market exclusivity to 2045 makes AD04 a far more attractive asset for larger pharmaceutical companies looking to enter the addiction space with an innovative, late-stage product. The clear regulatory pathway mapped out with the FDA provides an additional layer of validation that is crucial in partnership negotiations.

As Adial implements the FDA's recommendations and prepares to launch its new, precision-focused Phase 3 trial, the company stands at a crucial juncture. The successful publication of its international patent application is more than a procedural step; it is a foundational piece of its ambition to bring a new generation of personalized medicine to the millions of people worldwide struggling with Alcohol Use Disorder.