Polisan has initiated an international clinical trial to evaluate Citoflavin (inosine/nicotinamide/riboflavin/succinic acid) for the treatment of diabetic polyneuropathy, a common complication of diabetes.
According to the company’s press service, the study is multicenter, double-blind, placebo-controlled, and randomized, assessing the efficacy and safety of a combination therapy — intravenous administration of Citoflavin solution followed by tablets.
The project is being conducted at four research centers in India. Patient preparation has already begun at one of them. Simultaneously, the company has submitted documents to the regulatory authority, the Central Drugs Standard Control Organization (CDSCO), to obtain a license for importing Citoflavin for the study.
The clinical trial is expected to last about one year and conclude by the end of 2026.
The company emphasized that this study is an important step in expanding the evidence base for Citoflavin and confirming its potential in treating neurodegenerative complications of diabetes.
Meanwhile, the number of international clinical trials involving Russia has sharply declined in recent years: from 367 in 2021 to 18 in 2024. Last year, international trials accounted for only 2.9% of all clinical trials in the Russian Federation. However, Russian officials believe that the decline in international trials is successfully offset by local ones.
