Drug intelligence / Profile preview

ITI-007 long-acting injectable

Development stage: Unknown
Lead developer: Intra-Cellular Therapies
Modality: Small Molecules
Administration: Subcutaneous, Intramuscular

Overview

ITI-007 long-acting injectable (ITI-LLAI) is an extended-release formulation of lumateperone, a small molecule antipsychotic developed by Intra-Cellular Therapies. It is designed for once-monthly administration via subcutaneous or intramuscular injection to treat schizophrenia and schizoaffective disorder. The drug's unique mechanism of action involves potent serotonin 5-HT2A receptor antagonism, cell-type-specific dopamine D2 receptor modulation (acting as a post-synaptic antagonist and pre-synaptic partial agonist), glutamate receptor modulation through the stimulation of NMDA-NR2B receptor phosphorylation, and serotonin reuptake inhibition. This multi-target profile aims to provide efficacy in treating positive and negative symptoms of schizophrenia while maintaining a favorable safety and tolerability profile, particularly regarding metabolic and motor side effects. It is currently in Phase 1 clinical development.

Other names: lumateperone long-acting injectable

Targets

DRD2 (Dopamine D2 Receptor)HTR2A (Serotonin receptor 5-HT2A)SERT (Sodium-dependent serotonin transporter)

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