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 an investigational small molecule developed by Adial Pharmaceuticals, Inc. (ticker ADIL) for the treatment of Alcohol Use Disorder. It is being studied as a treatment for adults with AUD and selected serotonin transporter polymorphisms. AD04 is in Phase 3 clinical development and has not been approved by the FDA.
AD04 is being developed for the treatment of Alcohol Use Disorder (AUD) in adults. The Phase 3 study enrolled adults aged 18 years and older with AUD and selected serotonin transporter polymorphisms. AD04 is investigational and has not been approved for any indication.
AD04 is developed by Adial Pharmaceuticals, Inc., which trades under the ticker ADIL. The company is the sponsor of the Phase 3 clinical program evaluating AD04 in adults with Alcohol Use Disorder and selected serotonin transporter polymorphisms.
AD04 is in Phase 3 clinical development. Its Phase 3 trial, NCT04101227, has been completed. AD04 is investigational and has not been approved by the FDA for Alcohol Use Disorder or any other indication.
AD04 has been evaluated in one Phase 3 clinical trial, NCT04101227, titled "Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms." The trial was completed and enrolled 302 participants across Bulgaria, Croatia, Estonia, Finland, Latvia, Poland, and Sweden.
AD04 is also known as AD04 (ondansetron). The drug is a small molecule being developed by Adial Pharmaceuticals, Inc. for Alcohol Use Disorder, and it is referenced in the literature and company materials under the ondansetron name.