IQVIA Gets CDSCO Panel Nod to Study KarXT in Schizophrenia

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to IQVIA RDS (India) for conducting the trial of KarXT, a combination of Xanomeline Tartrate and Trospium Chloride.

This came after the firm presented phase III clinical study protocol no. KAR-013 version 5.0 dated 02 Nov 2023. This is an open-label extension study to assess the long-term safety and tolerability of adjunctive KarXT in subjects with inadequately controlled symptoms of schizophrenia.

Xanomeline is a dual M1 and M4-preferring muscarinic receptor agonist that does not block D2 dopamine receptors, unlike all currently approved treatments for schizophrenia. Xanomeline-trospium (KarXT) combines xanomeline with the peripherally restricted muscarinic receptor antagonist trospium chloride with the goal of ameliorating xanomeline-related adverse events associated with peripheral muscarinic receptors.

At the recent SEC meeting for Neurology and Psychiatry held on 16th October 2024, the expert panel reviewed the phase III clinical study protocol no. KAR-013 version 5.0 dated 02 Nov 2023.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the condition that protocol no. KAR-012 shall be approved by CDSCO.

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