Adial Pharmaceuticals Announces Publication of International PCT Patent Application to Protect Core Assets and Extend IP Exclusivity to at least 2045
Rhea-AI Summary
Adial (NASDAQ: ADIL) announced publication of an international PCT patent application for AD04 on January 14, 2026. AD04 is described as the company’s lead investigational genetically targeted serotonin-3 receptor antagonist for treating Alcohol Use Disorder (AUD) in heavy drinking patients (defined in the release as < 10 drinks/drinking day). The company said the patent, if granted, is expected to protect Adial’s core assets through at least 2045. Management attributed the application to an extensive examination of clinical data after hiring new patent counsel and said the filing was originally made in July 2024.
Positive
- Published PCT application for AD04 (Jan 14, 2026)
- Patent, if granted, would extend IP protection to at least 2045
- AD04 identified as lead genetically targeted AUD therapeutic
Negative
- Application is published but not yet granted, outcome uncertain
- Company remains clinical-stage with no commercial revenue
News Market Reaction – ADIL
On the day this news was published, ADIL declined 1.15%, reflecting a mild negative market reaction. Argus tracked a trough of -11.8% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $73K from the company's valuation, bringing the market cap to $6M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ADIL was down 3.05% while peers were mixed: BCLI +0.17%, VYNE +0.96%, TNFA -9.72%, CELZ -20.18%, and ALZN flat. With no peers in the momentum scanner and no same-day peer news, the move appears stock-specific rather than a coordinated biotech sector reaction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 26 | Warrant financing | Neutral | +1.0% | Warrant inducement raising about $2.86M gross via exercised warrants. |
| Nov 14 | Earnings update | Neutral | +1.9% | Q3 2025 results with cash of $4.6M and funding into Q2 2026. |
| Oct 17 | Media appearance | Neutral | -3.4% | CEO featured on The Big Biz Show expanding company visibility. |
| Oct 09 | Partnership deal | Positive | +4.7% | Genomind partnership and 100% concordant cheek-swab companion test validation. |
| Sep 16 | Clinical update | Positive | -0.9% | FDA supported adaptive Phase 3 design and biomarker-positive strategy for AD04. |
Recent news, including financing, FDA interactions, and IP updates, has often seen modest positive or mixed price reactions, with no consistent pattern of strong rallies or selloffs following announcements.
Over the last few months, ADIL has focused on financing, regulatory milestones, and precision-medicine positioning for AD04. A September 16, 2025 update highlighted favorable FDA End-of-Phase 2 feedback and adaptive Phase 3 plans. An October Genomind partnership and cheek-swab test validation supported the biomarker strategy and referenced patent protection to 2045. Q3 2025 earnings on November 14, 2025 reiterated funding into Q2 2026. A November 26, 2025 warrant inducement raised about $2.86M. Today’s patent publication and IP extension fit this ongoing effort to strengthen AD04’s commercial and regulatory foundation.
Regulatory & Risk Context
An effective S-3 filed on 2025-12-12 registers up to 13,823,512 shares of common stock for resale upon exercise of Series F warrants. Adial would receive cash only if these warrants are exercised, with the filing highlighting that the registered shares are large relative to the existing equity base, creating potential dilution and stock overhang if fully issued.
Market Pulse Summary
This announcement highlights publication of an international patent application for AD04, filed in July 2024, which is expected to protect Adial’s core assets through at least 2045. It reinforces the company’s focus on a genetically targeted serotonin-3 receptor antagonist for Alcohol Use Disorder in heavy drinking patients defined as < 10 drinks/drinking day. In context of prior FDA End-of-Phase 2 guidance and recent financing activity, investors may watch how this IP position supports Phase 3 execution and partnering or funding strategies.
Key Terms
international pct patent application regulatory
serotonin-3 receptor antagonist medical
alcohol use disorder (aud) medical
genetically targeted medical
AI-generated analysis. Not financial advice.
New patent based on treatment of populations identified to be particularly responsive to ondansetron treatment after examination of Adial’s clinical data and information
GLEN ALLEN, Va., Jan. 14, 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, 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.
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 with planning for the next phase of Adial’s clinical program, bolstering and leveraging the Company’s intellectual property portfolio 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, 2024, 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
FAQ
What did Adial (ADIL) announce about AD04 on January 14, 2026?
How long could the AD04 patent protect Adial (ADIL) if granted?
What is AD04 and which patients is it intended for in Adial's (ADIL) program?
Does publication of a PCT application mean Adial’s (ADIL) patent is approved?
What action by Adial preceded the new PCT application publication?
