BCD-089

Originator investigational product
List of clinical studies

BCD-089 is one of the medicinal products in BIOCAD’s clinical development program.

BCD-089 (international non-proprietary name: levilimab) is an investigational medical product for human use, a monoclonal antibody for the treatment of rheumatoid arthritis and novel coronavirus disease (COVID-19).

A monoclonal antibody is a protein created by scientists in the laboratory, which is equivalent to natural immune system antibodies and designed to bind to a specific target in the human body. Levilimab specifically binds to the interleukin-6 receptor protein, which results in a strong anti-inflammatory effect. Levilimab was previously studied in several non-clinical and clinical studies and is currently authorized by the Ministry of Health of the Russian Federation in the form of a solution for subcutaneous injection for the pathogenesis-based therapy of cytokine release syndrome in severe novel coronavirus infection (COVID-19) and for the treatment of moderate to severe rheumatoid arthritis in adults who have inadequately responded to therapy with one or more disease-modifying antirheumatic drugs, including those for slowing down radiological progression.

The clinical trial BCD-089-5/LUNAR evaluates the efficacy and safety of levilimab when administered intravenously, as well as when administered subcutaneously in new dosing regimens for the indication of rheumatoid arthritis.

  1. State Register of Medicines
  2. Ilsira® (Levilimab) official website

This website section contains information about the clinical study of the medicinal product for human use.