An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)

Inclusion Criteria:

1. Subject is aged 18 to 65 years, at time of enrollment into the preceding acute study (KAR-007/009).

2. Subject is capable of providing informed consent.

3. A signed informed consent form must be provided before any study assessmentsare performed.

4. Subject must be fluent in (oral and written) English (United States only) orlocal language (Ukraine only) to consent.

5. Subject has completed the treatment period on study drug (through Day 35 -2 days) ofStudies KAR-007 or KAR-009.

6. Subject resides in a stable living situation, in the opinion of the investigator.

7. Subject has an identified, reliable informant/caregiver willing to be able toaddress some questions related to certain study visits, if needed. Aninformant/caregiver may not be necessary if the subject has been the patient of theinvestigator for ≥1 year.

8. Women of childbearing potential or men with sexual partners of childbearingpotential must be sexually abstinent (in line with their preferred and usuallifestyle) or willing and able to use at least 1 highly effective method ofcontraception during the study and for at least 7 days after the last dose of KarXT.Sperm donation is not allowed for 7 days after the final dose of KarXT.

Exclusion Criteria:

1. Risk for suicidal behavior during the study as determined by the investigator'sclinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).

2. Any clinically significant abnormality, including any finding(s) from the physicalexamination, vital signs, ECG, or laboratory test at the end-of-treatment visit ofStudies KAR-007 or KAR-009 that the investigator, in consultation with the medicalmonitor, would consider to jeopardize the safety of the subject.

3. Female subject is pregnant.

4. If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable forenrollment in the study or subject has any finding that, in the view of theinvestigator (and/or Sponsor), may compromise the safety of the subject or affecthis/her ability to adhere to the protocol visit schedule or fulfill visitrequirements.

5. Subjects with extreme concerns relating to global pandemics such as coronavirusdisease 2019 (COVID-19) that preclude study participation.

6. Risk of violent or destructive behavior.

7. Subjects participating in another investigational drug or device trial or planningon participating in another clinical trial during the course of the study.