Adial Pharmaceuticals announced on September 16, 2025, the receipt of the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA), held on July 29, 2025. These minutes provide the FDA’s formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy.
This positive feedback marks a key milestone in advancing AD04 toward registration. The FDA’s alignment covers critical elements of the planned adaptive study design, including target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and affirmation of the biomarker-positive and biomarker-negative groups.
Adial is implementing FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development. This milestone is expected to accelerate strategic partnership discussions, as regulatory clarity is a significant consideration for potential collaborators.
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