Adial Pharmaceuticals Completes FDA Meeting, Advances AD04 into Phase 3 Clinical Development

Adial Pharmaceuticals has completed a successful End of Phase 2 meeting with the FDA, aligning on the design of the Phase 3 clinical development program for its lead investigational drug, AD04, for treating Alcohol Use Disorder. The FDA has provided input on the adaptive study design, population, endpoints, inclusion/exclusion criteria, dose regime, and biomarker positive/negative groups. Adial is now prepared to advance AD04 into its Phase 3 program.

Title: Adial Pharmaceuticals Completes Successful End of Phase 2 Meeting with FDA, Advances AD04 into Phase 3 Clinical Development

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) has completed a successful End of Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA), marking a significant milestone in its clinical development program. The FDA provided valuable input on the design of the Phase 3 clinical development program for AD04, the company's lead investigational drug aimed at treating Alcohol Use Disorder (AUD) [1].

The EOP2 meeting focused on aligning with the FDA on key elements of the Phase 3 adaptive study design, including population, endpoints, inclusion/exclusion criteria, dose regime, and biomarker positive/negative groups. This regulatory alignment is crucial for the clinical development of AD04, a serotonin-3 receptor antagonist, and will help refine the trial design to focus on the AUD population most likely to benefit from the treatment [1].

Adial Pharmaceuticals is now prepared to advance AD04 into its Phase 3 clinical development program for the treatment of AUD in individuals with heavy drinking and select genotypes, including the AG+ genotype. The company's CEO, Cary Claiborne, expressed optimism about the FDA's feedback and the progress made over the past several months, which included advanced statistical analytics and simulation modeling to refine the trial design [1].

The successful completion of the EOP2 meeting is expected to strengthen Adial's position in discussions with potential partners, as regulatory clarity is a key de-risking milestone in the decision-making process. The company is now well-positioned to advance its clinical program for AD04 and achieve a successful outcome in the Phase 3 program [1].

References:
1. [Adial Pharmaceuticals Completes Successful EOP2 FDA Meeting](https://www.globenewswire.com/news-release/2025/08/06/3128272/26135/en/Adial-Pharmaceuticals-Completes-Successful-EOP2-FDA-Meeting.html)