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Biotechnology: Pharmaceutical Preparations
Clinical TrialApr 22, 2026, 09:38 AM

Adial Completes AD04 Demonstration Batch for Phase 3 Program

AI Summary

Adial Pharmaceuticals announced the successful completion of the demonstration batch production for AD04, its lead investigational drug for Alcohol Use Disorder. This milestone confirms the manufacturing process meets targeted specifications for the planned Phase 3 clinical program and matches the dissolution profile of the previous Phase 2 batch. The successful technical transfer to a new CDMO enables the production of clinical and registration batches, which are essential for conducting the upcoming clinical trial and updating the Investigational New Drug (IND) application with the FDA.

Key Highlights

  • Successfully completed AD04 demonstration batch production.
  • Process met targeted specifications for planned Phase 3 clinical program.
  • Matched dissolution profile of previous Phase 2 batch.
  • Enables production of clinical and registration batches.
  • Supports ongoing discussions with the FDA for AD04.