Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

Inclusion Criteria:

• Has a primary diagnosis of schizophrenia established by a comprehensive psychiatricevaluation based on the DSM-5 (American Psychiatric Association 2013) criteria andconfirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophreniaand Psychotic Disorder Studies version 7.0.2.

• Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening andBaseline.

• Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.

• Willing and able to discontinue all antipsychotic medications prior to baselinevisit.

Exclusion Criteria:

• History or presence of clinically significant cardiovascular, pulmonary, renal,hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic,neurologic, or oncologic disease or any other condition that, in the opinion of theinvestigator, would jeopardize the safety of the participant or the validity of thestudy results.

• Any primary DSM-5 disorder other than schizophrenia within 12 months beforescreening.

• History of treatment resistance to schizophrenia medications.

• History of allergy/hypersensitivity to KarXT.

• Other protocol-defined Inclusion/Exclusion criteria apply.