Adial And Molteni Enter Collaboration Explore Exclusive European Partnership For AD04, Deal Valued At Nearly $60M

Adial Pharmaceuticals, Inc. announced it has entered into a collaboration framework agreement with Molteni Farmaceutici to explore an exclusive partnership for the commercialization of AD04 in Europe. The framework outlines the strategic and financial structure of the proposed partnership and is subject to the execution of a final definitive agreement.

Under the terms of the framework, Molteni has been granted a period of exclusivity to evaluate the project. During this time, the company will conduct due diligence, assess clinical, regulatory, manufacturing, and commercial requirements, and develop launch planning strategies for AD04 across European markets.

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “This agreement represents a significant milestone for Adial and would be our first commercial partnership. Molteni brings deep expertise in SUD treatment and a well-established European infrastructure spanning regulatory, manufacturing, and commercialization. Molteni’s longstanding focus in SUD treatment and integrated European platform make them an ideal partner as we advance AD04 toward commercialization. We believe this collaboration framework validates the commercial potential of AD04 and supports our strategy to advance AD04 in both Europe and the United States.”

If finalized, the agreement is expected to include an upfront payment to Adial, milestone payments linked to development and commercial progress, and tiered royalties ranging from high single digits to low double digits on European net sales. The total potential value from milestones and royalties is estimated at nearly $60 million, assuming AD04 advances successfully through clinical development and achieves commercial launch in Europe. This marks Adial’s first formal step toward building a European commercialization pathway for the asset.

Molteni, founded in 1892 and headquartered in Florence, Italy, brings established expertise in pain management and Substance Use Disorder (SUD) treatments, supported by integrated in-house manufacturing, R&D, regulatory, supply chain, and commercial capabilities, along with broad European and global distribution reach.

Gianluca Corbinelli, CEO of Molteni, added, “This collaboration aligns with Molteni’s strategic focus in Substance Use Disorder treatment, and we believe AD04 represents a compelling opportunity in a large area of unmet need. We are excited to enter into this exclusive framework agreement with Adial and begin building the foundation for a potential European commercialization partnership. We believe our integrated capabilities across development, manufacturing, regulatory, and commercialization position us well to support the goal of bringing this genetically targeted therapeutic option to patients in need.”

The partnership follows several strategic upgrades to Adial’s AD04 development program. These include a genotype-driven precision medicine approach targeting patients with a specific single nucleotide polymorphism (SNP) linked to efficacy, alignment of U.S. and European regulatory strategies to strengthen endpoint probability, manufacturing agreements with Thermo Fisher Scientific and Cambrex to support supply continuity, and a newly filed patent that could extend exclusivity from 2031 to 2045. Additionally, Adial has simplified its genetic screening process by replacing blood-based testing with a cheek swab method to improve scalability. The company is also engaging potential U.S. commercial partners as it prepares to initiate its pivotal Phase 3 program.