The Russian biopharmaceutical company Promomed has announced the start of a medical study for its new antibiotic Vilpramycin SAR® (active ingredient: josamycin). As reported by the company’s press service, the main objective of the project is to evaluate the efficacy and safety profile of the drug in routine clinical practice.
Full-Cycle Localized Production
The market launch of Vilpramycin SAR®, registered in October 2025, compensated for the shortage of josamycin in pharmacies and medical institutions following the withdrawal of Astellas’ original drug from the Russian market.
To ensure a stable supply and eliminate import dependence, the Promomed Group has localized the full-cycle production of the antibiotic. Manufacturing—from the synthesis of the active pharmaceutical ingredient to the final packaging—is carried out at the Biochemist plant facilities in Saransk.
Pharmacological Properties and Applications
Josamycin belongs to the macrolide class and has the ability to suppress intracellular microorganisms. The drug is used for infections caused by pathogens that have developed resistance to standard therapy. In clinical practice, it is prescribed for the treatment of:
- Upper and lower respiratory tract infections;
- ENT diseases;
- Skin and soft tissue infections;
- Infectious diseases of the eyes and genitourinary system.
The Only Dispersible Form in Russia
The Russian josamycin is produced in the form of soluble (dispersible) tablets with a dosage of 1000 mg. Currently, it is the only josamycin drug available in this form on the Russian market. This formulation is particularly relevant for patients who have difficulty swallowing solid tablets and is actively used in pediatrics.
At the attending physician’s discretion, josamycin can be prescribed to children, as well as to women during pregnancy and breastfeeding. The drug has been officially included by the Russian Ministry of Health in the updated 2025 clinical guidelines for the treatment of community-acquired pneumonia in children.
Objectives of Post-Registration Studies:
Collecting data in real-world clinical practice allows for the study of the drug’s effects across a broad patient population with comorbidities and varying histories of antibiotic therapy. This contributes to building a robust evidence base and increasing the medical community’s confidence in Russian pharmaceutical developments.
