IQVIA Gets CDSCO Panel Nod to Study Antipsychotic drug Lumateperone
New Delhi: IQVIA has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of Lumateperone, an antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia.
However, this approval is subject to the condition that the firm should submit a separate protocol for pharmacokinetic study in statistically significant Indian subjects.
This came after the firm presented phase 3 clinical study protocol no. ITI-007-452, Amendment 1, dated 03 Jul 2024.
Lumateperone is a novel 2nd-generation antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia.
Lumateperone is unique among second-generation antipsychotics based on its target profile and dopamine D2 receptor occupancy. Unlike other antipsychotics, lumateperone has partial agonist activity at presynaptic dopamine (D2) receptors, resulting in reduced presynaptic release of dopamine, and antagonistic activity at postsynaptic dopamine (D2) receptors. These characteristics allow lumateperone to efficiently reduce dopamine signaling.
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