Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07424404 | A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively | PHASE3 | RECRUITING | 400 | — | — | Apr 7, 2026 | Mar 8, 2030 | May 11, 2026 | 59 | United States, Argentina +8 |
| NCT07288567 | A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN) | PHASE3 | RECRUITING | 166 | — | — | Jan 29, 2026 | Dec 18, 2029 | Jun 2, 2026 | 41 | United States, Argentina +3 |
| NCT06882785 | A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia | PHASE3 | RECRUITING | 250 | — | — | Jun 10, 2025 | Aug 23, 2029 | May 13, 2026 | 56 | Japan |
| NCT06572449 | Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia | PHASE3 | COMPLETED | 173 | — | — | Oct 28, 2024 | Mar 13, 2025 | Apr 2, 2025 | 6 | United States |
| NCT07061288 | A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia | PHASE1 | RECRUITING | 48 | — | — | Sep 3, 2025 | Oct 15, 2027 | Dec 22, 2025 | 8 | United States |
Open-label extension (OLE) Part
| Arm | Type | Description |
|---|---|---|
| Administration of KarXT for Schizophrenia | EXPERIMENTAL | - |
| Administration of KarXT for Autism-related Irritability | EXPERIMENTAL | - |
| KarXT | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Administration of KarXT | ACTIVE_COMPARATOR | - |
| KarXT on empty stomach and with food | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| KarXT | DRUG | Specified dose on specified days |
| KarXT Matching Placebo | OTHER | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
Inclusion Criteria \- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptabl...