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.
Lumateperone also targets dopamine (D1) receptors, and a useful secondary result of D1 activation is increased glutamatergic N-methyl-D-aspartate (NMDA) GluN2B receptor phosphorylation. This is significant since NMDA-mediated glutamate signaling appears to be impaired in patients who have schizophrenia.
Finally, lumateperone is capable of modulating serotonin by inhibiting serotonin transporters (SERT) and by behaving as a 5-HT2A receptor antagonist.
At the recent SEC meeting for Neurology and Psychiatry held on 29th October 2024, the expert panel reviewed the phase III clinical study protocol no ITI-007-452, Amendment 1, dated 03 Jul 2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm, with the condition that the firm should submit a separate protocol for pharmacokinetic study in statistically significant Indian subjects.
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