GLEN ALLEN, Va. — March 3, 2026 — Leads & Copy — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) has entered a collaboration framework agreement with Molteni Farmaceutici for a proposed exclusive partnership to commercialize AD04 in Europe.
The agreement is subject to a final definitive agreement. The collaboration framework outlines strategic and financial parameters of the planned partnership, including clinical, regulatory, manufacturing, and commercial terms. Molteni has been granted exclusivity to evaluate the project’s feasibility, conduct planning and due diligence, and assess the requirements for a successful AD04 commercial launch across Europe.
The definitive agreement is expected to include an upfront payment, milestone payments tied to development and commercial progress, and tiered royalties (ranging from high single digits to low double digits) on European AD04 net sales, payable to Adial. The total potential aggregate value from royalties and milestones is estimated at nearly $60 million, assuming AD04 progresses through clinical development and is successfully introduced in the European market.
According to Adial, the collaboration framework represents its first step toward establishing a European commercial pathway for AD04.
Established in 1892 and headquartered in Florence, Italy, Molteni is a specialty pharmaceutical company with a presence in pain management and Substance Use Disorder (SUD) treatment. Molteni has integrated in-house manufacturing, research and development (R&D), regulatory, supply chain, and commercial capabilities, along with distribution coverage across Europe and globally.
Cary Claiborne, President and Chief Executive Officer of Adial, said the agreement represents a significant milestone for Adial and would be its first commercial partnership. Claiborne added that Molteni brings expertise in SUD treatment and a European infrastructure spanning regulatory, manufacturing, and commercialization, making them an ideal partner as Adial advances AD04 toward commercialization. He also stated the company believes this collaboration framework validates the commercial potential of AD04 and supports its strategy to advance AD04 in both Europe and the United States.
Adial says this partnership follows a multi-year effort to restructure, refine and optimize the AD04 clinical development program, informed by prior clinical insights. The Company has implemented advancements designed to position AD04 for commercialization.
Adial states that a rigorous re-analysis of clinical data identified that efficacy is largely driven by a single nucleotide polymorphism (SNP), allowing them to design a more focused, cost-efficient clinical program with a de-risked profile and a high probability of success.
Post-hoc analysis and clinical modeling utilizing a more rigorous U.S. regulatory endpoint increases the probability of achieving the established European Medicines Agency (EMA) clinical endpoint for Alcohol Use Disorder (AUD). This refined strategy supports an integrated clinical program designed for the planned simultaneous development of AD04 for the United States, European Union, and United Kingdom markets.
The Company has secured agreements with leading U.S. manufacturers, including Thermo Fisher Scientific and Cambrex, to support a secure supply chain for the production of AD04 for clinical trials and potential post-approval commercialization.
Adial filed a new patent covering its recent clinical analysis findings. If granted, this patent would extend the Loss of Exclusivity (LOE) date by an additional 14 years, from 2031 to 2045.
The prior blood draw process for genetic screening has been replaced with a modern, fast, and cost-effective cheek swab test.
Gianluca Corbinelli, CEO of Molteni, said the collaboration aligns with Molteni’s strategic focus in Substance Use Disorder treatment, and they believe AD04 represents an opportunity in an area of unmet need. Corbinelli also stated they are excited to enter into this exclusive framework agreement with Adial and begin building the foundation for a potential European commercialization partnership. They believe their integrated capabilities across development, manufacturing, regulatory, and commercialization position them well to support the goal of bringing this genetically targeted therapeutic option to patients in need.
Adial is also engaging with potential commercial partners in the United States as it prepares to initiate its pivotal Phase 3 program.
Adial Pharmaceuticals is focused on developing treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.
Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity.
Source: Adial Pharmaceuticals, Inc.
