The Russian drug Tirzetta® (INN tirzepatide) has confirmed the highest standards of quality and purity in an independent scientific study

PROMOMED Company announces the publication of the results of an independent comparative study[1] conducted by a consortium of leading Russian scientific centers, including Lomonosov Moscow State University and the Russian University of Medicine. The work, performed in full compliance with international regulatory standards (EMA, FDA, EAEU), was devoted to the analysis of the domestic drug Tirzetta®[2] and its foreign analogue based on the active substance tirzepatide.

Tirzetta® is Russia's first drug based on tirzepatide, a fundamentally new two—receptor agonist. It was developed and released by PROMOMED in 2025. The drug is indicated for the treatment of adult patients with type 2 diabetes mellitus, as well as for weight control in obese or overweight adults with concomitant diseases.

The study not only proved the complete physico-chemical and biological equivalence of the drugs, but also revealed important qualitative advantages of the Russian product developed and manufactured by PROMOMED, such as a high degree of purification of the active substance and a formula free of preservatives.

One of the key conclusions of the work was the establishment of a high purity index of the substance tirzepatide used in Tirzette. Methods of high-precision chromatographic analysis (HPLC-MS/MS) have shown that the Russian preparation contains 4.2 times less impurities compared to the original foreign sample. This factor is of critical importance for the safety of long-term therapy, which is required by such chronic conditions as type 2 diabetes mellitus and obesity. Achieving this level of purity was made possible by the use of advanced synthesis technologies and multi-stage purification at PROMOMED's own full-cycle production facilities.

Scientists have confirmed the uniqueness of the formula of Tirzetta®, which completely excludes antimicrobial preservatives such as phenol and benzyl alcohol. They are no longer needed due to the use of a modern delivery system — a ready-to-use disposable auto-injector. This device ensures complete sterility and stability of the medicinal solution, minimizing the potential risks of allergic reactions and increasing safety for patients with concomitant diseases.

At the same time, in vitro laboratory tests on human cell lines stably expressing target receptors (GLP-1 and GIP) confirmed that the biological activity of Tirzetta has no statistically significant differences with the reference drug (p<0.0001). This provides a reliable scientific basis for extrapolating to Tirzette the impressive results of international clinical programs (SURMOUNT, SURPASS), which demonstrated a reduction in body weight of up to 23% and a significant improvement in glycemic control.

Unlike foreign practice, where tirzepatide is represented by different trade names for the treatment of diabetes and obesity separately, the drug Tirzetta® is registered in Russia for both of these vital indications at once. This versatility simplifies prescribing for doctors and makes modern therapy more accessible to a wide range of patients, which corresponds to the strategic objectives of import substitution and strengthening the pharmaceutical sovereignty of the country. Sources

1. Makarevich P.I., Alexandrushkina N.A., Podlesnaya P.A., Kazaishvili Yu.G., Belyy P.A., Zaslavskaya K.Ya., Taganov A.V., Dyakova I.N., Shcherbakova L.I., Koryanova K.N., Mishchenko E.S., Shcherbakova V.S. Evaluation of Physicochemical Properties and Biolog
2. This drug is a prescription drug and should only be purchased as prescribed by a doctor. The drug has contraindications. Please read the instructions for use. Do not use the drug if it has not been prescribed to you by your