The Ministry of Health of the Russian Federation granted the Russian company R-Pharm permission to carry out phase I clinical trials of RB-030 (tirzepatide) for the treatment of diabetes mellitus, according to data from the State Register of Medicines (GRLS). The company plans to compare it with the original drug, Eli Lilly’s Munjaro. Initially, rights to tirzepatide were protected by a patent; however, according to the Eurasian Patent Organization (EAPO), in November 2024, its effect in Russia was terminated at the request of the copyright holder, notably Eli Lilly.
According to the state register, R-Pharm’s drug is a solution for subcutaneous administration with a dosage of 10 mg/ml. R-Pharm intends to conduct comparative studies on pharmacokinetics, bioequivalence, pharmacodynamics, safety, and immunogenicity between RB-030 and Munjaro in healthy volunteers, with 90 participants planned for the trials.
The company has engaged only one Moscow-based organization, OOO Research Lab, to conduct this research.
The US Food and Drug Administration (FDA) registered Munjaro for the treatment of type II diabetes in May 2022. A year later, the FDA approved the drug for weight loss in patients without type 2 diabetes, based on studies involving 2,539 adults.
However, the Eli Lilly medication was never registered in Russia. The patent for tirzepatide was terminated in November 2024, and at the same time, the drug was registered domestically by two companies, Promomed and Geropharm.
Following the termination of patent protection, Geropharm initiated legal proceedings against Eli Lilly, seeking a compulsory license for tirzepatide. The case is now under consideration by the Moscow Arbitration Court, with the Eurasian Patent Organization (EAPO) and Rospatent participating as procedural parties.
