Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AD04 (ondansetron)
AD04 · 1 trial · 1 indication
Change from baseline in the percentage of monthly HDDs, where (heavy) drinking is defined as the consumption of ≥ 60 g alcohol/day (if male) or ≥ 40 g alcohol/day (if female).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | AD04 (ondansetron) |
| Placebo Arm | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| AD04 (ondansetron) | DRUG | AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID) |
| Matching placebo | DRUG | Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID) |
| Companion Diagnostic for Genetic Testing | DEVICE | Companion Diagnostic for Genetic Testing |
| Brief Psychological Counseling | BEHAVIORAL | Brief Psychological Counseling |
Inclusion Criteria: 1. The subject has signed the Informed Consent Form. 2. The subject has breath alcohol concentration (BAC) of 0.00% at the Screening and \< 0.02 % at the Baseline visit. 3. The subject has moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Me...
AD04 is being developed for the treatment of alcohol use disorder (AUD) in adults. It is a small molecule therapeutic candidate studied in a Phase 3 clinical trial that enrolled 302 adults aged 18 and older with AUD. The trial was conducted in Bulgaria, Croatia, Estonia, Finland, Latvia, Poland, and Sweden.
AD04 targets the serotonin-3 receptor, a receptor in the serotonin system. By acting on this receptor, AD04 is designed to modulate serotonin signaling, which is being investigated for its role in alcohol use disorder. The drug is a small molecule developed by Adial Pharmaceuticals.
AD04 is being developed by Adial Pharmaceuticals, Inc., a biopharmaceutical company whose common stock trades under the ticker symbol ADIL. Adial Pharmaceuticals is advancing AD04 as a potential treatment for alcohol use disorder.
AD04 is in Phase 3 clinical development for alcohol use disorder. It has completed one Phase 3 trial, NCT04101227, which was a randomized, double-blind, placebo-controlled study that enrolled 302 participants. AD04 is investigational and has not been approved by the FDA.
AD04 has been studied in the Phase 3 trial NCT04101227, titled "Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms." This trial is completed and enrolled 302 adults across seven European countries. No other clinical trials of AD04 are currently active.
AD04 is also known as AD04 (ondansetron). The active ingredient in AD04 is ondansetron, a small molecule that targets the serotonin-3 receptor. Adial Pharmaceuticals is developing AD04 as a potential treatment for alcohol use disorder.