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.