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Adial Prescribed drugs at the moment introduced receipt of the ultimate assembly minutes from its finish of part 2 (EOP2) assembly with the US Meals and Drug Administration (FDA) held on July 29, 2025. The minutes present the FDA’s formal enter and constructive suggestions on the AD04 part 3 adaptive medical trial design and broader medical growth technique.1
The aim of the EOP2 assembly was to align with the FDA on the design of the part 3 medical growth program for Adial’s lead investigational drug, AD04, a genetically focused selective serotonin-3 receptor (5-HT3) antagonist and therapeutic agent in growth for alcohol use dysfunction (AUD) in sufferers who have interaction in heavy consuming (outlined as < 8 drinks/consuming day) and choose genotypes.2
“We consider we’re at an inflection level in Adial’s journey,” mentioned Cary Claiborne, president and chief government officer of Adial. “The profitable completion of our finish of part 2 assembly with the FDA has offered vital steerage that strengthens the medical and statistical framework for our upcoming part 3 trial of AD04. With regulatory alignment on key protocol components, together with affected person inhabitants, efficacy endpoints, biomarker stratification, and adaptive enrichment methods—we at the moment are positioned to advance a streamlined and scientifically rigorous program designed to maximise the chance of success.”
The assembly minutes mirror a “constructive dialogue” on AD04. Highlights from the assembly suggestions embrace:
The FDA supported Adial’s protocol and proposed adaptive trial design core components, such because the outlined biomarker-positive and biomarker-negative sufferers, key inclusion standards focusing on reasonable to extreme AUD, trial length, major endpoints, interim evaluation pattern measurement, and security monitoring framework. The FDA additionally confirmed the proposed major efficacy endpoints for AD04: 0 heavy consuming days throughout months 5 and 6 of the efficacy remark interval. The FDA was on board with Adial’s plan to account for homozygous populations, referencing steerage on growing focused therapies for low-frequency molecular subsets, with implications for research design and potential labeling of uncommon subgroups.
The FDA did advise Adial that key secondary endpoints supposed for future product labeling ought to be prespecified within the protocol. The FDA additionally offered suggestions on the deliberate interim analyses, statistical evaluation plan, and knowledge monitoring committee construction.
“This milestone displays greater than regulatory progress—it demonstrates our dedication to precision medication. By integrating pharmacogenetic insights and validated biomarkers into our growth technique, we’re enhancing medical predictability and setting a brand new benchmark for focused therapeutics in neuropsychiatry,” mentioned Claiborne. “This progress, coupled with the latest announcement of our new patent submitting for AD04 probably extending market exclusivity to 2045, body the AD04 program as an especially enticing future business alternative with a significant affected person affect. We stay targeted on delivering a transformative resolution for sufferers residing with AUD.”
Adial is within the technique of implementing these FDA suggestions, guaranteeing readiness to advance towards registrational part 3 growth. The AD04 program is designed for a subset of the inhabitants with AUD, sufferers who’re biomarker constructive for AG+, recognized via Adial’s proprietary genetic check. Based on analysis, the AG+ biomarker is current in roughly 14% of the overall inhabitants.
“As we advance towards part 3, we consider we’re executing from a place of energy throughout regulatory, medical, and manufacturing fronts. This milestone can be a catalyst for strategic partnership discussions, which we anticipate to speed up with FDA alignment now in place,” concluded Claiborne. “With disciplined execution, we consider AD04 is positioned to turn out to be the primary genetically focused remedy for AUD—addressing a big, underserved affected person inhabitants and unlocking a extremely enticing business alternative.”
References
1. Adial Prescribed drugs supplies enterprise replace following favorable feedback from FDA end-of-phase 2 (EOP2) assembly for AD04. Information launch. September 16, 2025. Accessed September 16, 2025. https://www.globenewswire.com/news-release/2025/09/16/3150713/26135/en/Adial-Prescribed drugs-Offers-Enterprise-Replace-Following-Favorable-Feedback-from-FDA-Finish-of-Part-2-EOP2-Assembly-for-AD04.html
2. Kuntz L. Finish of part 2 assembly with the FDA: Adial prepares to advance AD04 for alcohol use dysfunction. Psychiatric Occasions. August 6, 2025. https://www.psychiatrictimes.com/view/end-of-phase-2-meeting-with-the-fda-adial-prepares-to-advance-ad04-for-alcohol-use-disorder