Ministry of Health Approves Clinical Trial of Drug for Diabetic Foot Syndrome

The Ministry of Health has authorized Nextgen (Artgen Biotech) to conduct a Phase III clinical trial of the gene therapy drug Neovasculgen for the treatment of diabetic foot syndrome. The study will involve 188 patients across five clinical centers in Moscow, Voronezh, Novosibirsk, and Stavropol. Phase III, running until March 2027, will comprehensively assess the drug’s efficacy for diabetic foot syndrome – one of the most common complications of diabetes. Neovasculgen, the world's first registered gene therapy drug, is currently used for lower limb ischemia treatment and is included in the Essential Drugs List, national guidelines, and Moscow’s Compulsory Medical Insurance program.