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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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 

Clinical Trial Investigator

Dr. Carmen L. Espinosa-Perez