An original domestic drug for the treatment of patients with non-alcoholic fatty liver disease

The website of the Unified Information System in the Sphere of Procurement reported that the St. Petersburg State Chemical-Pharmaceutical University has submitted an application to conduct a phase II clinical trial of maloben in patients with non-alcoholic fatty liver disease. 

112 people will take part in the phase II study of maloben. The study is planned to be completed by 2027. The study will evaluate the efficacy and safety of the drug in tablet form at a dosage of 60 mg. 

The first phase of the study of maloben was conducted at the St. Petersburg Research Center for Eco-Safety and was completed in 2023. The study assessed the safety, tolerability, and pharmacokinetic parameters of the drug. The trial involved 32 healthy people. 

Maloben is a derivative of malonic acid, which has antisteatotic activity (prevention of fat deposition in liver cells). According to Sergei Okovity, head of the Department of Pharmacology and Clinical Pharmacology at the St. Petersburg State Chemical-Pharmaceutical University, maloben reduces the severity of hepatocyte apoptosis, i.e. their programmed death. In addition, it reduces the accumulation of carbohydrates and lipids. 

Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease associated with metabolic dysfunction: lipids accumulate in liver cells (hepatocytes), which in turn leads to lipotoxicity and inflammatory damage to liver cells. 

In 2024, the US Food and Drug Administration (FDA) approved only one drug to combat this disease, called Rezdiffra (resmetirom), which is not registered in Russia.