Adial has a number of drug candidates. Here is our current pipeline with current stage of development.
At this stage, researchers seek to invent and make potential candidates molecules targeted at a particular receptor and mechanism of action. Numerous candidate molecules are then screened in a battery of in vitro and animal in vivo experiments to gather info regarding potency, selectivity, solubility, biodistribution, dosing and efficacy. Route of administration is also usually determined at this stage.
At this stage, a lead molecule has usually been selected. Additional studies are conducted in vitro and in vivo in animals to further determine the potential efficacy and toxicity before any human studies. Manufacturing of the drug candidate is also developed and conducted in a manner to allow dosing of humans.
Phase 1 & 2
During Phase 1 studies, researchers generally test a new drug candidate in healthy volunteers (healthy people) to evaluate the safety of a new drug candidate. Phase 2 studies, clinicians administer the drug candidate to patients with the targeted disease to initially assess its effectiveness, determine the best dose, and to further study its safety. Phase 1 studies usually have 10-70 patients per study and Phase 2 studies can often have a few hundred.
Phase 3 trials are conducted in patients with the disease. They are intended both to demonstrate the drug candidate’s positive effect in treating the target disease or disorder and to evaluate the drug’s safety and side effects (i.e., tolerability) at the dose expected to be used. Patients are usually randomly assigned to either drug or placebo so that none of the patients, the research clinicians, nor the company/sponsor know which patient receive drug and which received placebo until the end of the trial. Phase 3 trials usually have hundreds of patients and can often have thousands.