MSN Laboratories Gets CDSCO Panel Nod To study Brexpiprazole Tablets

New Delhi: Considering the bioequivalence study of Brexpiprazole Tablets 0.25mg /0.5 mg/1mg/2mg/3mg/4mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to drug maker MSN Laboratories to conduct a Phase III clinical trial study of the Brexpiprazole Tablets.

However, this approval is subject to the condition that the clinical trial sites should be geographically distributed with 50% government sites and include a qualified psychiatrist by training and experience as the principal investigator, as the drug (brexpiprazole) will be evaluated in psychiatric patients.

This came after the firm presented a proposal for a grant of permission to manufacture and market Brexpiprazole Tablets 0.25mg/0.5 mg / 1mg /2mg /3mg /4mg, along with a bioequivalence study report and phase III clinical trial protocol, before the committee.

Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist called a serotonin-dopamine activity modulator (SDAM). It has a high affinity for serotonin, dopamine, and alpha (α)-adrenergic receptors.

Although the exact mechanism of action of brexpiprazole in psychiatric disorders has not been fully elucidated, the efficacy of brexpiprazole may be attributed to combined partial agonist activity at 5-HT1A and dopamine D2 receptors and antagonist activity at 5-HT2A receptors. Brexpiprazole binds to these receptors with subnanomolar affinities. These therapeutic targets have been implicated in psychiatric conditions such as schizophrenia and depression.

At the recent SEC meeting for Neurology and Psychiatry held on 19th March 2025, the expert panel reviewed the proposal for grant of permission to manufacture and market Brexpiprazole Tablets 0.25mg/0.5 mg/1mg/2mg/3mg/4mg, along with Bioequivalence study report and Phase III Clinical trial protocol.

After detailed deliberation, the committee considered bioequivalence study results and recommended granting permission to conduct a Phase III clinical trial study as per the protocol presented, subject to the following conditions.

1. Clinical trial sites should be geographically distributed with 50% government sites.

2. The firm should include a qualified psychiatrist by training and experience as the principal investigator, as the drug (brexpiprazole) will be evaluated in psychiatric patients.

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