Sunobinop tosilate

Table of contents

• What is sunobinop tosilate?
• How does sunobinop tosilate work?
• Which conditions is sunobinop tosilate studied for?
• How is sunobinop tosilate given?
• What do the clinical trials show?
• What side effects are known?

What is sunobinop tosilate?

Sunobinop tosilate is an investigational substance that has been studied in people with alcohol use disorder. It is also known by the development code V117957. The substance is not authorised as a medicine in any country, and the clinical research on it is still at an early stage. The only trial identified in the registry records is a Phase 2 study, which means the substance has passed initial safety testing and has been tried in a small group of patients to look for signs of benefit.^[1]

How does sunobinop tosilate work?

The registry records do not describe the mechanism of action of sunobinop tosilate. The trial was designed to test whether sunobinop reduces heavy drinking in people with alcohol use disorder, but the biological pathway through which it might do this is not stated in the available data.^[1]

Which conditions is sunobinop tosilate studied for?

• Alcohol use disorder (AUD) — a condition in which a person has difficulty controlling their alcohol consumption despite harmful consequences. The Phase 2 trial tested whether sunobinop could reduce the percentage of heavy drinking days in people with this condition.^[1]

How is sunobinop tosilate given?

Sunobinop tosilate was given by mouth in the form of tablets. The trial compared three different oral doses — 0.5 mg, 1 mg and 2 mg — against a placebo tablet that looked the same but contained no active substance.^[1]

What do the clinical trials show?

One completed Phase 2 trial has investigated sunobinop tosilate in alcohol use disorder. The study enrolled 200 participants and was interventional, meaning participants received the study treatment and were then followed over time. The trial compared three doses of sunobinop (0.5 mg, 1 mg and 2 mg) with placebo, all taken by mouth as tablets.^[1]

The main outcome measured in the trial was the percent heavy drinking days (HDD), assessed using the Timeline Followback interview. This is a method in which participants report their daily alcohol consumption retrospectively, allowing researchers to calculate how many days met the definition of heavy drinking. The purpose of the study was to evaluate whether sunobinop, compared with placebo, would reduce the percentage of heavy drinking days.^[1]

The trial is registered as NCT06545916 and has the status Completed, meaning the study has finished and the data have been collected. The registry record does not include the results of the trial, so it is not possible to say from this source whether sunobinop was effective.^[1]

What side effects are known?

The available registry record does not report side effects for sunobinop tosilate. No supplementary sources were provided, so no information on adverse events is available for this page.