Luye Pharma Group Ltd. (stock code: 02186) has obtained clearance from the U.S. Food and Drug Administration (FDA) to initiate clinical trials for LY03017, a next-generation serotonin 2A receptor inverse agonist and serotonin 2C receptor antagonist. This investigational new drug is intended to treat Alzheimer’s disease psychosis (ADP), Parkinson’s disease psychosis (PDP), and the negative symptoms of schizophrenia (NSS). Following the waiver of the single ascending dose trial in Phase I, LY03017 can proceed directly to multiple ascending dose trials and subsequent clinical stages in the United States.
Developed on the group’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03017 is also in a Phase I study in China. According to the announcement, there are approximately 45 million Alzheimer’s patients worldwide, 25–50% of whom may experience psychotic symptoms. Parkinson’s disease affects over 8.5 million people globally with a lifetime psychosis prevalence of about 60%, while schizophrenia impacts around 23 million individuals with roughly 60% experiencing NSS. Existing treatments for PDP, ADP, and NSS remain limited, and LY03017’s dual-target mechanism offers potential benefits for managing hallucinations, delusions, and negative symptoms. Preclinical studies indicate higher pharmacological activity, favorable tissue distribution, and improved cardiac safety compared to existing therapies.
CNS disorders constitute a core strategic focus for Luye Pharma. The company has a diversified portfolio addressing major depressive disorder, schizophrenia, bipolar disorder, and Alzheimer’s disease. Its marketed products include Erzofri® and Rykindo® in the U.S.; Rivastigmine patches in Europe, Japan, and China; as well as Ruoxinlin® and Jinyouping® in China. Ongoing research extends to other next-generation therapies such as LY03015 (targeting VMAT2/Sigma-1R), LY03020 (targeting TAAR1/5-HT2CR), and LY03021 (targeting NET/DAT/GABAAR). The announcement was dated 24 November 2025.
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