Hong Kong–listed Luye Pharma Group Ltd. enrolled the first subject in a randomized, double-blind, placebo-controlled Phase II trial of its in-house candidate LY03017 for Alzheimer’s disease-related psychosis (ADP), according to a voluntary announcement dated 15 April 2026.

LY03017 is a next-generation dual-target compound acting as a 5-HT2A receptor inverse agonist and 5-HT2C receptor antagonist, with potential indications that also include Parkinson’s disease psychosis and negative symptoms of schizophrenia. The China Phase II study will evaluate the drug’s preliminary efficacy and safety in treating delusions and hallucinations in Alzheimer’s disease. Regulatory clearance has also been obtained to start clinical trials in the United States.

Unmet medical need remains high: the World Health Organization estimates that 57.00 million people live with dementia globally, of which 60%–70% are Alzheimer’s patients; 25%–50% of these patients develop psychotic symptoms for which no approved therapy currently exists.

In a completed Phase I trial in China, LY03017 demonstrated rapid oral absorption, linear pharmacokinetics, achievement of steady state after about three days of repeat dosing, and a safety profile limited to mild-to-moderate adverse events without serious treatment-emergent events.

Central nervous system (CNS) disorders are a strategic focus for Luye Pharma. Commercialized CNS assets include Erzofri (paliperidone palmitate) and Rykindo (risperidone) extended-release injectables in the United States; a Rivastigmine twice-weekly transdermal patch marketed in Japan, China and several European countries; and Ruoxinlin (toludesvenlafaxine hydrochloride sustained-release tablets) in China. Additional pipeline programs in clinical development target VMAT2/Sigma-1R (LY03015), TAAR1/5-HT2C (LY03020) and GABAAR/NET/DAT (LY03021).

Management stated that accelerating the LY03017 Phase II program is intended to address the substantial unmet needs in AD-related psychosis at the earliest opportunity.