Luye Pharma’s Rykindo® approved by FDA for treatment of schizophrenia and bipolar 1 disorder

pharmafile | January 16, 2023 | News story | Research and Development  

International pharmaceutical company, Luye Pharma, has announced that Rykindo® has received FDA approval for the treatment of schizophrenia in adult patients, and alongside lithium or valproate for the treatment of bipolar 1 disorder in adult patients.

The drug is an extended-release injectable suspension treatment, developed by Luye Pharma on its microsphere technology platform. Administered via an intramuscular injection once every two weeks, the drug delivers the active ingredient, risperidone, through a long-acting and extended-release microsphere technology.

With 40 million bipolar disorder patients worldwide in 2019 and currently approximately 24 million schizophrenia patients, new treatments for these mental disorders are in demand.

Rykindo® has been approved for marketing in China since 2021 for the treatment of schizophrenia, and is progressing in Europe, with plans to launch in various other countries going forward.

Yang Rongbing, president of Luye Pharma Group, commented: “Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and the society. Rykindo® is our first new drug developed in-house and approved for marketing in the US, demonstrating our long-standing commitment to serving patients around the world with innovative therapies. At Luye Pharma, we continue to enrich our product portfolio in the CNS field by focusing on the unmet needs of patients, and we look forward to making further contributions to the mental health community by providing better care and better services to those in need.”


Betsy Goodfellow

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