Adial Pharmaceuticals Partners with Thermo Fisher and Cambrex for AD04 Manufacturing

• Adial Pharmaceuticals has signed agreements with Thermo Fisher Scientific and Cambrex for the drug product and drug substance manufacturing of AD04.

• The collaborations will support upcoming clinical trials and the planned NDA submission to the FDA for the treatment of Alcohol Use Disorder.

Adial Pharmaceuticals, Inc. has announced strategic manufacturing agreements with Thermo Fisher Scientific and Cambrex to support the production of its lead investigational therapy, AD04. The drug is being developed for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.

Thermo Fisher has been appointed as the contract development and manufacturing organisation (CDMO) for the AD04 drug product, while Cambrex will serve as the CDMO for the active pharmaceutical ingredient, ondansetron. Demonstration batches have already been completed ahead of clinical and registration batch production.

The agreements cover manufacturing for both clinical trial supplies and the Chemistry, Manufacturing, and Controls (CMC) documentation needed for Adial’s upcoming New Drug Application (NDA) to the U.S. FDA. Adial emphasised the importance of selecting CDMOs with drug substance and drug product capabilities in the United States to mitigate tariff-related risks and ensure commercial readiness.

“As our readiness in planning the future Phase 3 registrational study program for AD04 continues, these agreements with Thermo Fisher and Cambrex are another key component in our planning,” said Cary Claiborne, President and CEO of Adial.