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Find Clinical Drug Pipeline Developments & Deals by Adial Pharmaceuticals
AD04 (ondansetron) is an investigational - genetically targeted serotonin-3 receptor antagonist, which is being evaluated for the treatment of Alcohol Use Disorder.
The net proceeds will be used in the clinical development of AD04 (ondansetron), which is a Serotonin 5-HT3a receptor antagonist. It is being evaluated in the clinical trial studies for patients with alcohol use disorder.
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
The Company’s lead investigational new drug product, AD04 (ondansetron), is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.
At 30 minutes post dose, PNV-5030 reduced pain by 43% compared to the control group, while acetaminophen doses did not have a significant effect. PNV-5030 also demonstrated a 49% improvement in pain reduction over acetaminophen (APAP-25mg/kg).
In the study, PNV-6005 demonstrated statistically significant effect against both primary study endpoints, which are pre-clinical endpoints expected to indicate potential efficacy against ulcerative colitis in humans.
AD04 (ondansetron) achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking.
In studies of Zofran, patients were given AD04 (ondansetron) acutely at dosages up to almost 100 times dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously which results in almost twice exposure level as oral dosing.
Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 (ondansetron) in patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes.
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