Obninsk Chemical and Pharmaceutical Company (part of the Mir-Pharm group of companies) has received the Ministry of Health’s approval for phase 3 of clinical trials of a drug based on molnupiravir. This is evidenced by the data from the State Register of Medicines.
As the protocol describes it, it is “a multicenter, two-stage study, open at the first stage and double-blind at the second stage, to assess the main pharmacokinetic parameters, safety and efficacy against COVID-19 of molnupiravir, 200 mg capsules, in the adult population”.
The trials will be conducted on the basis of four medical institutions in Moscow with the participation of 416 patients. It is planned that the tests will be completed on December 1, 2023.
ZAO Obninsk Chemical and Pharmaceutical Company (ZAO BKhPhC) is a modern production site in Obninsk (Kaluga region). Mir-Pharm is an international group of companies with its own R&D centers and production facilities in Russia and the European Union.
The Ministry of Health of Russia approved Lagevrio based on molnupiravir for circulation.
As it was reported earlier, the Russian pharmaceutical company Promomed has submitted an application for registration of Esperavir (INN molnupiravir), an antiviral drug used in the treatment of COVID-19.