Karuna Therapeutics’ NDA for KarXT accepted by USFDA

If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades

Karuna Therapeutics has announced that U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

Bill Meury, President and CEO, Karuna Therapeutics said, “We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process. There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia.”

The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT.

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. KarXT was found to be generally well tolerated, with the most common adverse events being 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.

Rishi Kakar, M.D., CSO and medical director of Segal Trials, and investigator in the EMERGENT program said, “KarXT focuses on a novel pathway through muscarinic receptors to indirectly modulate dopamine signaling in key brain circuits, and in clinical trials completed to date KarXT has demonstrated the much-needed combination of strong tolerability and clinically meaningful symptom reduction. This decision by the FDA marks an important step in working toward a new chapter in the standard of care for those facing the immense, daily struggle of this serious mental illness.”


clinical studydrug approvalNDASchizophreniaUSFDA
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