FDA Approves Luye Pharma’s Rykindo for Schizophrenia and Bipolar I Disorder

The FDA has approved China-based Luye Pharma’s Rykindo (risperidone) extended-release injectable suspension for adults with schizophrenia and as maintenance treatment, either as monotherapy or as adjunctive therapy with lithium or valproate, in adults with bipolar I disorder.

The treatment is administered by intramuscular injection once every two weeks and delivers the active drug ingredient risperidone through long-acting and extended-release microsphere technology.

Rykindo was approved in China in 2021 for the treatment of schizophrenia. The company now plans to seek regulatory approval in other parts of the world, including Europe.