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# Karuna NDA for Schizophrenia Accepted by FDA
- URL: https://www.fdaweb.com/karuna-nda-for-schizophrenia-accepted-by-fda/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155879

FDA has accepted for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults. The agency has set a 9/26/2024 review action target date. Karuna says the submission is based on data from the company’s EMERGENT clinical trial program. “In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared to placebo as measured by Positive and Negative Syndrome Scale (PANSS) total score,” it says.

On the safety side, KarXT was found to be generally well tolerated, Karuna says, adding that the most common adverse events reported were cholinergic in nature and mild to moderate in severity. “Notably, KarXT was not associated with common side effects of currently available antipsychotics, including weight gain, somnolence, and movement disorders,” it says.

KarXT works by focusing on a novel pathway through muscarinic receptors to indirectly modulate dopamine signaling in key brain circuits, the company says, adding that unlike other treatments, the drug does not directly block dopamine receptors. It is also being studied as a treatment for psychosis related to Alzheimer’s disease.