360° Insights: Karuna Therapeutics' KarXT

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Karuna Therapeutics is developing KarXT (xanomeline and trospium) for the treatment of schizophrenia and Alzheimer's disease psychosis. Xanomeline is a new molecular entity that has demonstrated antipsychotic and pro-cognitive properties; trospium is a muscarinic antagonist that offsets the peripheral cholinergic effects of xanomeline. Trospium was first approved as Allergan's Sanctura in 2004 for the treatment of overactive bladder.

Karuna has indicated that it plans to submit a New Drug Application (NDA) to the FDA for schizophrenia in mid-2023, which would allow for approval of KarXT sometime in 2024. The company has also indicated it will submit a supplemental NDA (sNDA) for use of KarXT as an adjunctive treatment for schizophrenia soon after filing for the monotherapy indication.

If approved, KarXT would be the first muscarinic agonist for the treatment of schizophrenia to enter the market. Herein, we provide a selection of key points included in our full reports.