The Ministry of Health of the Russian Federation has granted permission to Geropharm, a Russian company, to carry out the initial phase of clinical trials for a medication developed with semaglutide—a counterpart of Novo Nordisk’s Ozempic drug. The original drug, originally intended for the treatment of type 2 diabetes, is now also used to combat excess weight.
The initial stage of the injectable drug with the code name GP40221 (semaglutide), is projected to extend until May 2024. In the initial stage, the drug’s pharmacokinetics will be assessed alongside its biosimilarity to Ozempic, using 120 participants as test subjects. The tests are scheduled to take place at Clinical Hospital in Yaroslavl.
In a statement exclusively given to GxP News, Petr Rodionov, the CEO of Geropharm, provided his comments:
“Officially, the clinical trials are set to conclude in May 2024. However, we anticipate being able to finish them more quickly while adhering to all the standards of best practices. Given that the foreign drug is already faulty, it is imperative that patients have immediate access to the alternative”, he said/
Semaglutide molecule patent will remain valid until 2031, with two components of the substance securely protected until 2025 and 2038.
