EXCLUSIVE: Adial Pharma Eyes Europe Deal For Lead Drug For Alcohol Use Disrder Worth Up To $60 Million

Adial Pharmaceuticals Inc. (NASDAQ:ADIL) on Tuesday entered into a collaboration framework agreement with Molteni Farmaceutici for a proposed exclusive partnership covering the commercialization of AD04 in Europe.

The collaboration framework, which is subject to execution of a final definitive agreement, sets forth the strategic and financial parameters of the planned partnership, covering clinical, regulatory, manufacturing, and commercial terms.

Lead Drug AD04 Overview

AD04 is the company's lead investigational program for Alcohol Use Disorder (AUD) in heavy drinking patients.

Adial is currently planning to conduct a new Phase 3 clinical trial program for 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.

Deal Could Bring Nearly $60 Million in Milestones and Royalties

Under the framework, Molteni has been granted a period of exclusivity to evaluate the feasibility of the project, conduct planning, due diligence, and a comprehensive assessment of the requirements for the successful commercial launch of AD04 across Europe.

The definitive agreement is expected to include an upfront payment, milestone payments, 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 over time is estimated at nearly $60 million, assuming AD04 progresses through clinical development and is successfully introduced in the European market.

The collaboration framework represents Adial's first step toward establishing a European commercial pathway for AD04.

Cary Claiborne, President and CEO of Adial, commented, "This agreement represents a significant milestone for Adial and would be our first commercial partnership…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."

U.S. Trial Pathway

Adial is also actively engaging with potential commercial partners in the U.S. as it prepares to initiate its pivotal Phase 3 program in the near term.

In September 2025, Adial Pharmaceuticals received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July.

The minutes provide the FDA's formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy.

ADIL Price Action: Adial Pharmaceuticals shares were up 7.69% at $2.66 during premarket trading on Tuesday. The stock is trading near its 52-week low of $2.27.