Russia’s Health Ministry has granted Croatian drugmaker Belupo permission to conduct a bioequivalence trial for vortioxetine. The active ingredient was developed and patented by Denmark’s Lundbeck, which markets the drug in Russia under the brand Brintellix. Belupo has engaged a single clinical site for the trial – St Petersburg‑based X7 Clinical Research.
According to the state medicines registry, the trial is expected to be completed by the end of 2026. It will involve 30 healthy volunteers and will test Belupo’s formulation of film‑coated tablets at a 20 mg dosage.
The trial will compare the pharmacokinetics of the original drug and Belupo’s generic to establish bioequivalence. According to the registry, Belupo has not previously held any marketing authorisations for pharmaceuticals in Russia.
The original Brintellix was registered in Russia in early 2016. Although vortioxetine is protected by patents in Russia – one Eurasian patent expires in October 2027 and another in January 2031 – the registry already lists five other trials of analogues of the antidepressant. Earlier trial approvals were granted to chemical holding Kontsentratsiya (formerly AppScience), as well as to drugmakers Ammedart, Otisipharm and Atoll (part of the Ozon Pharmaceuticals Group), and India’s Hetero Labs Limited.
In September 2025, Lundbeck announced a major restructuring involving the closure of its own commercial operations in 27 countries, including Russia, and the transfer of sales of its drug portfolio to regional partners. It was reported that Swixx Group would cover most of the countries (21), mainly in Eastern Europe and South America, including Russia and Israel.
Lundbeck said the move would allow it to focus capital on developing its innovative portfolio and new research areas, while distribution would be maintained through local market players.