Luye Pharma Wins FDA IND Clearance for Next-Generation CNS Drug LY03017
Luye Pharma Group Ltd. has received FDA clearance for its IND application for LY03017, a next-generation CNS drug. This approval allows the company to start clinical trials in the U.S. for treating Alzheimer’s disease psychosis, Parkinson’s disease psychosis, and negative symptoms of schizophrenia. The FDA has also exempted the single ascending dose trial in Phase I, allowing direct progression to multiple ascending dose and subsequent trials.
Luye Pharma Group Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for LY03017, a next-generation serotonin 2A receptor (5-HT2AR) inverse agonist and serotonin 2C receptor (5-HT2CR) antagonist. This regulatory approval allows Luye Pharma to initiate clinical trials in the United States for LY03017, which is intended for the treatment of Alzheimer’s disease psychosis, Parkinson’s disease psychosis, and the negative symptoms of schizophrenia. The FDA has also exempted the single ascending dose trial in the Phase I study, permitting the company to proceed directly to multiple ascending dose and subsequent clinical trials. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Luye Pharma Group Ltd. published the original content used to generate this news brief on November 24, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
