Adial Pharmaceuticals Advances IP Portfolio with New U.S. Utility Patent Application, Positioning for Potential Market Exclusivity Through 2045

New U.S. utility patent application targeting patient populations with demonstrated heightened responsiveness to ondansetron treatment, reinforcing Adial’s precision-medicine approach

GLEN ALLEN, Va., April 29, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the filing of a new U.S. utility application with the United States Patent and Trade Office (USPTO) directed to AD04, 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. Once the patent is granted, it is expected to protect Adial’s core assets through at least 2045.

The application is being filed with a Request for Track One Prioritized examination to expedite examination. The advantages of a Track One Prioritized examination include a substantially shorter examination time that will assist Adial with early patentability insights to refine strategy and a condensed prosecution.

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “As we advance the AD04 program toward its next clinical phase, this patent application represents a meaningful step in strengthening and extending the long-term value of our intellectual property portfolio. If the patent is granted, it is expected to secure protection for our core assets through at least 2045, reinforcing the durability of our potential commercial opportunity.”

“This application reflects a comprehensive post hoc analysis of our data and demonstrates our disciplined approach to maximizing asset value. It enhances our strategic positioning as we approach potential commercialization—both by supporting early enforcement capabilities and by increasing the attractiveness of AD04 in ongoing licensing discussions. We believe the potential for extended exclusivity meaningfully strengthens our negotiating position with prospective partners and enhances the overall value proposition of AD04 for U.S. and global commercialization opportunities.”

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.

Forward-Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the Company’s new patent application for AD04, the patent protecting Adial’s core assets out to at least 2045 once granted, continuing to advance the AD04 program toward its next clinical phase, strengthening and extending the long-term value of the Company’s intellectual property portfolio, the patent reinforcing the durability of the Company’s potential commercial opportunity once granted, enhancing the Company’s strategic positioning as it approaches potential commercialization both by supporting early enforcement capabilities and by increasing the attractiveness of AD04 in ongoing licensing discussions, the potential for extended exclusivity meaningfully strengthening the Company’s negotiating position with prospective partners and enhancing the overall value proposition of AD04 for U.S. and global commercialization opportunities and the potential of AD04 to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com