Adial Pharmaceuticals Highlights FDA Policy Direction That May Reduce Pivotal Trial Burden from Two Studies to One
Regulatory Shift Could Significantly Lower Phase 3 Costs and Accelerate Path Toward NDA Submission for AD04
GLEN ALLEN, Va., Feb. 23, 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 highlighted recent U.S. Food and Drug Administration (FDA) policy direction described by FDA Commissioner Martin A. Makary, M.D., M.P.H., and Vinay Prasad, M.D., M.P.H., in a commentary published February 19, 2026, in The New England Journal of Medicine. In the article, FDA leadership outlined a shift in the agency’s default evidentiary posture under which, where scientifically appropriate, approval may be supported by one adequate and well-controlled clinical investigation plus confirmatory evidence, rather than the historic expectation of two independent pivotal studies.
This policy direction reflects a modernization of evidentiary standards, emphasizing trial quality and confirmatory support over the number of trials conducted, while preserving the FDA’s discretion to evaluate each development program on its scientific merits.
Under Section 505(d) of the Federal Food, Drug, and Cosmetic Act, “substantial evidence” of effectiveness must be demonstrated through adequate and well-controlled clinical investigations. While this standard has historically been interpreted to generally require two such studies, FDA guidance and public FDA communications have described circumstances in which approval may be supported by a single adequate and well-controlled clinical investigation together with confirmatory evidence, where scientifically justified.
Cary Claiborne, President and Chief Executive Officer of Adial Pharmaceuticals, stated, “FDA’s policy direction confirming that, under appropriate scientific circumstances, approval may be supported by one adequate and well-controlled clinical investigation plus confirmatory evidence is a potentially transformative development for Adial. Historically, our Phase 3 strategy contemplated two pivotal trials, which represent the most expensive and time-intensive stage of drug development. If AD04 can ultimately be advanced under a one-study framework, the impact could be substantial — significantly lowering Phase 3 costs, improving overall capital efficiency, and accelerating our path toward NDA submission, without compromising agency standards. For a late-stage clinical program like AD04, that type of regulatory modernization meaningfully enhances the strategic and economic profile of the asset.”
Adial’s lead investigational drug candidate, AD04, is a genetically targeted serotonin-3 receptor antagonist for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. The Company is preparing for the next stage of clinical development and intends to engage closely with the FDA regarding the appropriate evidentiary strategy for AD04 consistent with current regulatory standards and policy considerations.
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 FDA’s recent policy direction being a potentially transformative development for the Company, advancing AD04 under a one-study framework, the impact significantly lowering Phase 3 costs, improving overall capital efficiency, and accelerating the path toward NDA submission, without compromising agency standards, meaningfully enhancing the strategic and economic profile of the asset, preparing for the next stage of clinical development and engaging closely with the FDA regarding the appropriate evidentiary strategy for AD04 consistent with current regulatory standards and policy considerations 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.
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