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 ongoing 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 a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. KarXT also demonstrated reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS negative Marder factor subscales, which were secondary endpoints in the trials.
KarXT was found to be generally well-tolerated, with the most common adverse events being cholinergic in nature and rated mild to moderate in severity. Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials. Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms.
When will it be available in Europe?
I hope its not the same as current meds as they said the same for 2nd gen APs that they improved negatives. In reality they make it worse.
I don’t know, but probably in 2026-2027. It takes 2 to 6 years to see a medication approved in another country.
Totally agree. KarXT, unlike conventional antipsychotics, does not generate negative symptoms. Because it doesn’t block the D2 receptors, that’s why I think.
i hope that karxt does not regulate all of the dopamine and doesnt make you emotionally numb
I wonder where the phase 3 study will be in detail. I should look it up on the internet.
go for it 151515
I am so excited for KarXT - karuna. Dont let me down pls