Adial Applauds Congressional Directive Advancing Alternative Clinical Trial Endpoints for Substance Use Disorders, Strengthening Regulatory Path for AD04
GLEN ALLEN, Va., Feb. 04, 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 applauded the passage by Congress and signing into law by President Donald J. Trump of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill, 2026.
The final legislation incorporates Senate Report 119-55, which includes a significant Congressional directive to the U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) to collaborate on the establishment of alternative clinical trial endpoints for medications treating substance use disorders, including Alcohol Use Disorder (AUD). The directive, titled “Alternative Clinical Trial Endpoints for Substance Use Disorders,” calls for endpoints beyond abstinence that demonstrate meaningful clinical benefit.
Specifically, Congress directed the FDA to consider endpoints such as reduced cravings or reduced disorder severity, where such measures reflect clinically meaningful improvement for patients. These non-abstinence-based outcomes align with the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA) updated definition of recovery, which recognizes improvements in functioning and symptom reduction as valid and impactful treatment goals.
Adial’s lead investigational therapy, AD04, is designed to address AUD using a precision medicine approach and is aligned with these non-abstinence recovery outcomes. As federal agencies including the FDA and NIDA are now formally directed to collaborate on defining and implementing these alternative endpoints, the measures are expected to strengthen the regulatory framework for innovative therapies such as AD04.
“This Congressional directive reflects a meaningful evolution in how substance use disorders are evaluated and treated,” said Cary Claiborne, President and Chief Executive Officer of Adial. “By embracing endpoints that recognize real-world clinical improvement beyond abstinence alone, policymakers are helping to modernize regulatory expectations and support innovation. We believe this action enhances the regulatory path for AD04 and reinforces Adial’s strategy to address the substantial unmet need in AUD with precision-based therapies.”
AUD remains a significant public health challenge, with millions of affected individuals and limited treatment options that achieve durable outcomes. Adial believes that regulatory clarity around alternative endpoints may help accelerate development timelines and broaden the clinical relevance of emerging therapies.
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 designing AD04 to address AUD using a precision medicine approach, the measures strengthening the regulatory framework for innovative therapies such as AD04, the policymakers helping to modernize regulatory expectations and supporting innovation, the action enhancing the regulatory path for AD04 and reinforcing Adial’s strategy to address the substantial unmet need in AUD with precision-based therapies, regulatory clarity around alternative endpoints helping to accelerate development timelines and broaden the clinical relevance of emerging therapies 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
