Russian pharmaceutical company Promomed has initiated the Phase IV clinical trials for its drug containing the active ingredient risdiplam, the company’s press service announced. The medication is intended for the treatment of spinal muscular atrophy (SMA), a disease that affects motor neurons, leading to progressive muscle weakness, atrophy, and paralysis.
In 2025, the company completed the full development cycle and obtained a marketing authorization for its risdiplam-based drug for the treatment of SMA in adults and children from 16 days of age.
The current study is investigating the safety and efficacy of administering risdiplam to patients who have previously received other disease-modifying therapies for SMA. The trial is being conducted across six centers, including the Veltischev Research Clinical Institute for Pediatrics and Pediatric Surgery, the Russian Center for Neurology and Neuroscience, the National Medical Research Center for Children’s Health, and the Moscow Regional Research Clinical Institute (MONIKI).
According to the company, the therapy’s outcomes will be evaluated over a two-year period in patients with infantile-onset SMA as well as in those with a later manifestation of the disease.
The foreign manufacturer of the original risdiplam-based drug, Roche, has already filed a lawsuit seeking to block the entry of its generic counterpart onto the Russian market. However, the court has refused to satisfy Roche’s injunction request.
