Lurasidone, developed by Sumitomo Pharma in Japan, is a medication prescribed for the treatment of schizophrenia and bipolar depression. In April 2017, Bukwang Pharmaceutical entered into an exclusive licensing agreement for the domestic development, marketing, sales, and distribution of Lurasidone.
Lurasidone is an antagonist that blocks dopamine D2, serotonin 5-HT2A, and serotonin 5-HT7 receptors, key neurotransmitters in the brain. Furthermore, it partially acts on serotonin 5-HT1A receptors, with minimal affinity for histamine H1 and muscarinic M1 receptors.
Compared to conventional atypical antipsychotic medications, Lurasidone offers a competitive advantage with lower incidence of metabolic side effects such as weight gain, increased prolactin, abnormal lipid levels, and elevated blood glucose. This advantage contributes significantly to enhancing patients' social functioning and overall quality of life.
Currently marketed as 'Latuda®' in North America, this product has achieved blockbuster status, with North America sales around $2 billion as of 2021. It has received approvals for schizophrenia treatment in 45 countries worldwide, including the United States, Canada, and the European Union (EU).
In July 2022, Bukwang Pharmaceutical confirmed the statistical significance of non-inferiority in a Phase 3 clinical trial comparing Lurasidone to the established schizophrenia treatment Quetiapine, among domestic schizophrenia patients.
Building on the positive Phase 3 clinical trial results, In October 2022, Bukwang Pharmaceutical submitted a New Drug Application (NDA) for Lurasidone to the Ministry of Food and Drug Safety, marking a significant step toward achieving domestic product approval.