EXCLUSIVE: Adial Pharmaceuticals Expands Patent Portfolio With New US Patent For Lead Drug For Alcohol And Opioid Use Disorders

The United States Patent and Trademark Office (USPTO) issued patent number 12,274,692 to Adial Pharmaceuticals, Inc.’s ADIL AD04 on Thursday.

The patent covers a method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients.

This newly issued patent strengthens Adial’s intellectual property portfolio by covering the administration of AD04, the company’s investigational drug.

Also Read: EXCLUSIVE: After FDA Response, Adial Starts Manufacturing Clinical Supplies For Upcoming Phase 3 Program Of Lead Candidate For Alcohol Use Disorder

The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations.

The granted claims include specific genetic profiles associated with treatment efficacy and the corresponding dosing regimens. 

Specifically for AUD, the patent claims cover a method of treatment for a broad definition of alcohol-related disorders, including disorders associated with alcohol use such as alcohol-induced or associated anxiety, bipolar, sexual dysfunction, sleep disorder, or gambling disorder, as well as alcohol withdrawal. 

In February, Adial Pharmaceuticals announced the United States Patent and Trademark Office issued patent number 12,221,654.

The patent expanded 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 drug product.

In January, Adial Pharmaceuticals completed the AD04-103 pharmacokinetics (PK) study for AD04, confirming predictable bioavailability, dose proportionality, no food effect, and a safety profile consistent with ondansetron’s use.

In November 2024, Adial Pharmaceuticals completed a pharmacokinetics (PK) study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than ten drinks/drinking day).

The results of this study showed that, due to the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states. 

Price Action: At the last check on Thursday, ADIL stock was down 0.52% to $0.69 during the premarket session.

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