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KarXT FDA Approval Status

Last updated by Judith Stewart, BPharm on Oct 10, 2023.

FDA Approved: No
Brand name: KarXT
Generic name: xanomeline and trospium
Company: Karuna Therapeutics, Inc.
Treatment for: Schizophrenia; Alzheimer’s Disease Psychosis

KarXT (xanomeline and trospium) is an M1/M4 muscarinic receptor agonist and antimuscarinic combination in development as an antipsychotic treatment for schizophrenia and psychosis related to Alzheimer’s disease.

Development timeline for KarXT

DateArticle
Apr  6, 2024Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society
Apr  6, 2024Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society
Nov 29, 2023Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia
Sep 28, 2023Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

Further information

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