A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term

The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703)
Primary diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),.
Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.
Outpatient status at the time of signing the informed consent form informed consent form (ICF).

Schizophrenia is considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks).
History of response to clozapine treatment only or failure to respond to clozapine treatment.
Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma
Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy
Positive pregnancy test result prior to receiving investigational medicinal product

Dr. Carmen L. Espinosa-Perez