Promomed has launched the JASMINE observational study to assess the efficacy and safety of the antibiotic Vilpramicin SAR (josamycin) for treating respiratory infections in children, the company told GxP News. The drug replaces the original Vilprafen from Japan’s Astellas, which halted supplies to Russia in 2023. No paediatric suspension form of josamycin has yet been registered in Russia.
If the study confirms the expected outcomes, it will broaden the drug’s use in paediatrics, where the choice of systemic antibiotics with proven efficacy and convenient dosing for children under three is limited.
The trial will be conducted at Children’s City Clinical Hospital No. 11 in Yekaterinburg under the auspices of the Ural State Medical University. The programme plans to enrol more than 400 patients aged 1 to 17 years with a diagnosis of acute respiratory infection. Data collection will run from June to December 2026.
The company said the study’s relevance stems from the high proportion of respiratory infections in childhood morbidity – they account for more than 90% of all infections in children, who fall ill four to five times more often than adults. Josamycin is being considered as an alternative to beta‑lactam antibiotics, including for treating atypical pathogens. According to the developer, the drug maintains one of the lowest resistance levels in the population and is suitable for patients with penicillin intolerance.
The company had previously begun studying josamycin’s efficacy in outpatient settings for urogenital infections. The new study aims to confirm its safety profile in children against the backdrop of a seasonal rise in acute respiratory infections in the second half of 2026.
The original drug was manufactured by Japan’s Astellas under the brand name Vilprafen. In 2020, the company announced a global discontinuation of production, and by the end of 2023 it had completely halted supplies to Russia. The decision followed a global business review and affected all dosage forms.
At the time, there were no generics available in Russia. The Health Ministry registered Promomed’s Vilpramicin SAR antibiotic in 2024. That same year, Farmstandard registered its own josamycin generic under the brand name Josafen.
