Luye Pharma Gets U.S. FDA Nod to Start Trials for New CNS Drug

MT Newswires Live

2025/11/24

Luye Pharma (HKG:2186) received U.S. FDA clearance to begin clinical trials for LY03017, its in-house developed dual-target central nervous system (CNS) drug, the company said in a Monday Hong Kong bourse filing.

The agency also waived the single-ascending-dose requirement, allowing the program to move directly into multiple-ascending-dose testing.

LY03017, intended for Alzheimer's disease psychosis, Parkinson's disease psychosis, and negative symptoms of schizophrenia, is already in a Phase 1 trial in China, the company said.

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