The aim. To conduct a comprehensive analysis of the clinical and pharmacological efficacy of progestins (dydrogesterone, dienogest, and norethisterone acetate) for the treatment of endometriosis by systematizing data on their pharmacodynamic, pharmacokinetic characteristics, and safety profile to optimize the selection of a personalized therapeutic strategy.

Materials and methods. The search of the literature was conducted regarding randomized controlled trials (RCTs), cohort studies, and meta-analyses for the period from 1958 to 2025 from the PubMed, Cochrane Library, and eLibrary.ru databases.

Results. It was found that dienogest, dydrogesterone, and norethisterone acetate demonsrates comparable efficacy in reducing the intensity of endometriosis-associated pelvic pain. Dienogest showed efficacy comparable to gonadotropin-releasing hormone agonists with a better tolerability profile. Dydrogesterone exhibited the best safety profile with minimal impact on metabolic parameters. Norethisterone acetate showed efficacy comparable to dienogest, but with more pronounced androgenic effects. Key pharmacological features affecting the safety profile of drugs were identified, and the need for a personalized approach to the choice of therapy was justified. The main limitation is the insufficient number of direct comparative studies of various progestins.

Conclusion. All the progestins considered are effective treatments for endometriosis, but have different safety profiles, which determines the need for individual drug selection, taking into account the patient’s characteristics and concomitant pathology. Promising areas for future research include conducting large multi-center RCTs, developing algorithms for personalized therapy selection, and studying the long-term effects of treatment.

The aim. To conduct a comparative analysis of long-term trends and structural features of patenting in the field of biotechnology at the national and regional levels.

Materials and methods. The study is based on data from two patent offices: the Federal Service for Intellectual Property (Rospatent) and the Eurasian Patent Office (EAPO) for the period from 2005 to 2024. The methodology includes a quantitative analysis of patent applications with classification by applicant countries and industry areas of biotechnology.

Results. It was found that the share of biotechnological patents is 4.68% in Rospatent and 8.33% in EAPO. The phenomenon of strategic duality was revealed: in the Russian Federation, Russian applicants dominate (61% of patents), while in the EAPO their share is only 9%, while non-residents form extensive patent portfolios there. The dynamics of patent activity demonstrates a clear correlation with external factors: an increase in the activity of non-residents in the EAPO after 2014 and a shift in industry priorities in the Russian Federation from medical to industrial biotechnology after 2019. At the same time, domestic patent activity in Rospatent has decreased by 16.5% the last five years.

Conclusion. The results indicate a systemic imbalance: Russia pursues a predominantly internally oriented patent strategy, focusing on the domestic market, and is significantly inferior in the formation of legal positions in the Eurasian space. The predominance of foreign patents in the EAPO creates long-term risks for the competitiveness of Russian developments in the region. The data obtained can be useful in the development of state programs to improve Russia’s competitiveness in the framework of biotechnological areas in the global market.

The aim. To analyze and summarize modern scientific data on the use of medicinal plant raw materials as a source of biologically active substances and herbal medicines (phytopreparations) in the therapy of chronic infectious and inflammatory diseases of the kidneys and urinary tract.

Materials and methods. The search for scientific data was carried out in international scientific electronic databases Google Scholar, Science Direct, PubMed, elibrary.ru and cyberleninka.ru. Publications for the period from 2010 to 2025 were studied. This review includes 446 sources of scientific information.

Results. Chronic infectious and inflammatory diseases of the kidneys and urinary tract (CIDKUT) are becoming an increasingly important problem and require special attention. Modern medicine and pharmacy have a variety of official medicinal plant raw materials (MPRMs) at their disposal, which are a source of biologically active substances (BASs) and phytopreparations for the treatment and prevention of kidney diseases. In addition, new promising plant objects are being actively studied. The presented results of preclinical phytochemical and pharmacological, as well as clinical studies, reliably indicate the presence of a significant influence of the identified BASs, in particular, components of essential oils and phenolic compounds, on the main links of pathogenesis and on the development of diuretic, anti-inflammatory, uroseptic, litholytic and antilithogenic effects. All of the above stimulates the development of new combined phytopreparations, for which various approaches have been noted in their standardization, the choice of methods for analyzing leading and related BAS.

Conclusion. The review examines and analyzes the current state of research in the field of using MPRM as a source of BASs of phytopreparations in the treatment of CIDKUT. It is shown that key classes of BAS of terpenoid and phenolic nature have anti-inflammatory, antibacterial, diuretic, litholytic and antilithogenic effects. A number of promising non-pharmacopoeial types of MPRMs have been identified: true bedstraw herb, annual sunflower roots, rosehip roots, angelica rhizomes and roots, cranberry fruits, which have extensive empirical experience in folk medicine, as well as the results of laboratory chemical and preclinical studies.

This article presents the interim results of the first stage (administration of the drug to patients aged ≥18 years with mucopolysaccharidosis type II) of a multicenter open multi-cohort phase II-III study (IDB-MPS-II-III), the aim of which was to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of veranafusp alfa in patients with MPS II.

Material and methods. The interim analysis included data from 3 patients aged 18 years and older who had previously received idursulfase (2/3) and idursulfase beta (1/3). An individual dose increase (1–2–3 mg/kg) was performed after 2 weeks, followed by administration at a dose of 3 mg/kg for up to 52 weeks (a total of 52 weekly infusions). Standard PK parameters were evaluated. The PD criterion was the level of glycosaminoglycans (GAGs) in urine, blood and cerebrospinal fluid (CSF). Efficacy parameters included assessment of the dynamics of GAGs concentration in urine, blood and CSF, range of motion in joints, liver and spleen volume, change in the 6-minute walk test (6MWT, 6-minute test), left ventricular myocardial mass, forced vital capacity of the lungs (FVC). Safety parameters included assessment of the frequency of adverse events (AEs) and adverse reactions (ARs), including allergic and infusion reactions, as well as assessment of the frequency of formation of anti-drug antibodies (ADAs) and their neutralizing activity.

Results. The studied drug demonstrated non-linear PK in the blood and a dose-dependent increase in concentration in the CSF. Patients showed a decrease or stability in the level of GAG in the urine, a decrease in the level of heparan sulfate (HS) in the CSF in 2 (66.6%) of 3 patients, as well as a decrease in the level of dermatan sulfate (DS) in the CSF in the range of 17.19–80.96%. There was an average decrease in liver volume by 42.500 ± 218.496 cm³, spleen volume by 24.350 ± 9.405 cm³ and left ventricular myocardial mass by 15.333 ± 43.016 g relative to the baseline level. The average increase in walking distance according to the results of the 6MWT, after 1 year of therapy, was 76.067 ± 83.561 m. The average values of FVC and FEV1 did not change statistically significantly. 9 AEs were registered in 3 patients (100.0%) of mild severity, mainly from the liver and biliary tract, and 3 ARs, which were infusion reactions and were registered mainly in the first 4 months of therapy. During the analyzed period, the frequency of formation of ADAs at screening was in 2 patients, and at week 52 — in 3 patients, which indicates the development of de novo ADAs during treatment with veranafusp alfa in 1 patient.

Conclusion. Weekly intravenous administration of the drug under study to adult patients at a dose of 3 mg/kg for 1 year provided control of the level of GAG in the urine and stabilization and/or improvement of somatic symptoms according to spirometry, echocardiography, 6MWT, range of motion in large joints, liver and spleen size, comparable to the results of the effectiveness of treatment with idursulfase in patients previously receiving enzyme replacement therapy. There was a tendency to decrease the level of HS in the cerebrospinal fluid, which may indicate the ability of veranafusp alfa to penetrate the BBB and deliver idursulfase to brain tissue, preventing the accumulation of pathological substrate in the CNS to prevent neurodegenerative changes.

Alzheimer’s disease (AD) is characterized by the progressive accumulation of beta-amyloid and impaired cognitive function. Existing treatments are not effective enough, it’s necessary to search for new therapeutic strategies targeting key pathogenetic mechanisms.

The aim. To investigate the therapeutic potential of intracellular and extracellular forms of heat shock protein HSP70 for correcting cognitive deficits and reducing amyloid load in AD.

Materials and methods. The study was performed on APPswe/PS1dE9/Blg transgenic mice, modeling AD, and lines created on their basis expressing intracellular (Tg_h) or extracellular (Tg_h_mod) forms of human HSP70. Behavioral tests were used to assess cognitive functions: Open Field, Novel Object Recognition, Y-maze, Barnes Maze. Amyloid load was assessed by histological method.

Results. The extracellular form of HSP70 (Tg_h_mod) significantly reduced amyloid load by 37% (p = 0.0033) and demonstrated marked cognitive improvement — by 40–45% in the Y-maze and Barnes Maze tests, whereas the intracellular form (Tg_h) reduced amyloidosis by 23.6% (p = 0.0273) but did not show significant memory recovery. The results indicate that the neuroprotective effect of extracellular HSP70 is likely mediated not only by chaperone activity but also by additional mechanisms critical for synaptic function.

Conclusion. A comparative study of the effectiveness of intracellular and extracellular forms of HSP70 in correcting both molecular and behavioral disorders in an AD model was conducted for the first time. It was found that the modified form of HSP70 has therapeutic potential. HSP70, especially its extracellular form, is a promising target for the development of AD therapy, providing a comprehensive effect on amyloid pathology and cognitive functions.

In the last decade, developed countries have seen a steady increase in the prevalence of metabolic disorders. The most significant among them are obesity and type 2 diabetes mellitus. Tirzepatide is an innovative drug, representing the first-in-class dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. Tirzepatide combines the action of two key incretin hormones, providing more comprehensive and effective regulation of glycemia and metabolism compared to traditional GLP-1 monoagonists. Tirzepatide was unavailable in Russia for a long time. However, in 2025, the first domestically produced tirzepatide drug, Tirzetta® (LLC “PROMMOMED RUS”), appeared.

The aim. To conduct a comparative evaluation of the efficacy and safety of the reproduced drug Tirzetta® (INN: Tirzepatide, manufacturer LLC “PROMMOMED RUS”) and the reference drug Mounjaro® (INN: Tirzepatide, manufacturer “Eli Lilly”) in a mouse model with induced metabolic syndrome (MS).

Materials and methods. The study was conducted on male mice of the C57BL/6 line. To metabolic syndrome (MS) was induced in animals with a diet high in fat and carbohydrates. Three batches of Tirzetta® and one series of Munjaro® were investigated. The drugs were administered at a dosage of 150 µg/kg subcutaneously once every three days for 15 days. During the experiment, glucose tolerance and insulin sensitivity tests were performed. The type of metabolism was determined by indirect calorimetry data. Mice were euthanized on 25th day for humane reasons upon reaching any of the following criteria: body weight loss of more than 15% in a week; serious injuries (fractures, amputations, etc.), appearance of non-healing wounds; seizures; unconscious state. A complete blood count was performed, and the following parameters were determined: glucose, triglycerides, cholesterol, AST, ALT. Necropsy was performed after euthanasia. During necropsy, the thoracic and abdominal organs of the animals were examined, and organs were dissected and weighed.

Results. In the MS group animals, body weight increased to 39.5 ± 0.6 g compared to the control group (31.9 ± 0.6 g), representing a 24% increase. Significant hyperglycemia was recorded with a glucose concentration of 14.9 ± 2.7 mmol/L versus 6.1 ± 0.4 mmol/L in the control, as well as a pronounced decrease in glucose tolerance in the loading test. The investigated tirzepatide drugs demonstrated a pronounced hypophagic effect with a 26–28% reduction in body weight, normalization of glycemia with a 48–53% decrease in glucose concentration, and improvement in glucose tolerance and insulin sensitivity. Indirect calorimetry data indicated a decrease in the respiratory exchange ratio, suggesting lipolysis activation. A significant reduction in triglyceride content in blood serum and liver was revealed. The bioequivalence of the investigated drugs Tirzetta® and Mounjaro® was established in the experimental MS model in mice based on a set of therapeutic efficacy and safety indicators.

Conclusion. Studies on an experimental model of induced MS in mice showed equivalent efficacy of Tirzetta® (INN: Tirzepatide, manufacturer LLC “PROMMOMED RUS”, Russia) and Mounjaro® (INN: Tirzepatide, manufacturer “Eli Lilly”, USA).