Adial Pharmaceuticals is a clinical-stage biopharmaceutical company with a single drug candidate, AD04, targeting alcohol use disorder (AUD). AD04's active ingredient is ondansetron — already approved at higher doses for nausea — administered at a very low dose (0.33mg) to patients who carry specific genetic variants in serotonin receptor genes HTR3A and HTR3B. A companion diagnostic test identifies these genotype-positive patients before treatment begins. Unlike the four FDA-approved AUD drugs, which require abstinence and carry significant side effects, AD04 is designed as a harm-reduction therapy: patients do not need to stop drinking before starting, and the goal is reducing heavy drinking rather than mandating full abstinence. Adial believes this addresses a major unmet need, given that only roughly 2.5% of the estimated 27.9 million Americans with AUD receive any medication today. Adial has no approved products and generates no revenue. If AD04 is approved, the intended model is a conventional branded pharmaceutical approach, sold through a U.S. commercial partner to genotype-positive patients at a branded price. Adial is also pursuing a European partnership with Molteni, under which Adial would receive milestones and tiered royalties on European sales. Adial licenses its core IP from the University of Virginia, paying a 2% royalty on net sales in patent-covered countries. Longer-term, Adial aims to expand AD04's label into opioid use disorder, obesity, smoking cessation, and other indications, though near-term resources are focused entirely on completing the AUD clinical program.