PROMOMED has registered Russia's first semaglutide in tablets, Semaltara®

PROMOMED has received a registration certificate for the drug Semaltara® (INN semaglutide) in tablet form. This is the first and currently the only representative of the class of glucagon-like peptide-1 (GLP-1) analogues available in tablet form in Russia, which is well known from such global blockbusters as Velgia® and Quincenta®. Registration of the drug Semaltara® is the first step towards ensuring stable availability of therapy and creating an alternative to the imported drug Rebelsas®.

Semaltara® is used to treat adult patients with type 2 diabetes mellitus in addition to diet and exercise. Semaglutide, the active ingredient of the drug, is an analogue of the natural hormone GLP-1, which is released in our body after eating and regulates carbohydrate metabolism. The drug stimulates the production of insulin, lowers glucose levels and helps reduce body weight by regulating appetite.

The release of semaglutide in oral form may become a more preferable option for patients who are not ready for injectable therapy. This empowers doctors and patients to choose an individual treatment strategy. Among the features of this release format are a convenient dosing schedule (three dosages), taking the drug once a day for one tablet, a compact package format that is convenient to carry, as well as simple storage conditions outside the refrigerator.

"We continue to develop our portfolio of drugs for the treatment of diabetes and obesity, offering personalized solutions for each patient. The appearance of the oral form of semaglutide opens up new opportunities for people for whom injections are a barrier to treatment. Semaltara® combines the effectiveness of a well—known active substance with the convenience of administration, which helps to increase adherence to therapy and expands the choice for doctors and patients," commentsKira Zaslavskaya, Director of New Products PROMOMED companies.

The drug will be available in three dosages: 3 mg, 7 mg and 14 mg. The initial dose is 3 mg once a day for a month. Then the dose is increased to 7 mg, and if necessary, further improvement of glycemic control — up to a maintenance dose of 14 mg once a day.

The efficacy and safety of semaglutide were evaluated in eight global randomized controlled clinical trials involving 8,842 patients with type 2 diabetes mellitus. Semaglutide showed high efficacy, a favorable safety profile, and a statistically significant advantage in terms of glycated hemoglobin control both in monotherapy (compared with placebo) and in comparison with other hypoglycemic drugs.