LY03010

LY03010 is a long-acting injectable (LAI) formulation of paliperidone palmitate, a second-generation antipsychotic, developed by Luye Pharma Group for the treatment of schizophrenia and schizoaffective disorder. It is an extended-release aqueous suspension administered once monthly via intramuscular injection in either the deltoid or gluteal muscle. The drug's mechanism of action involves the antagonism of central dopamine D2 and serotonin 5-HT2A receptors. Developed through the FDA's 505(b)(2) regulatory pathway, LY03010 has demonstrated bioequivalence to Invega Sustenna at steady state while offering an optimized initial dosing regimen intended to improve patient adherence and clinical outcomes. An NDA for LY03010 was submitted to the U.S. FDA in October 2023.

Other names

paliperidone palmitate extended-release injectable suspensionLY 03010LY03010LY-03010