AD04 is the company’s lead investigational genetically targeted serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients, following the ...

The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the company's lead asset, AD04 (low-dose ondansetron), and the placebo group among ...

Adial Pharmaceuticals (ADIL) announced a “positive” response from the U.S. FDA regarding its proposed in vitro bridging strategy for AD04. The FDA’s feedback follows Adial’s submission on ...

FDA feedback confirms Adial’s proposed in vitro bridging strategy to the Phase 3 formulation to fulfill the bridging requirement for the ...

Adial secured a new U.S. patent expanding methods for identifying genetic markers linked to substance use disorders and AD04 treatment. The company completed a pharmacokinetics study confirming ...

The FDA agreed with Adial’s proposed 505(b)(2) bridging strategy, supporting AD04's progression to Phase 3 trials in 2025. Adial’s AD04-103 study shows bioavailability, dose proportionality ...

This patent expands the covered methods of identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the Company’s investigational new ...

(RTTNews) - Adial Pharmaceuticals, Inc. (ADIL), a clinical-stage biopharmaceutical company, on Wednesday announced promising results from its AD04-103 Pharmacokinetics or PK Study for AD04 ...

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on ...

The FDA’s feedback follows Adial’s submission on November 19, 2024, in which the Company sought the Agency’s guidance on the alignment of its AD04 formulation strategy and bridging approach.

Successful completion of AD04-103 pharmacokinetics (PK) study of AD04, corroborating bioavailability, dose proportionality, no food effect, and safety profile consistent with the use of Ondansetron.