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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07227818 | Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia | PHASE3 | RECRUITING | 560 | — | — | Dec 16, 2025 | Jul 1, 2029 | Jun 5, 2026 | 20 | United States |
| NCT07105098 | NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia | PHASE3 | RECRUITING | 284 | — | — | Aug 11, 2025 | Nov 1, 2027 | May 15, 2026 | 15 | United States, Bulgaria +3 |
| NCT07114874 | NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia | PHASE3 | RECRUITING | 600 | — | — | Jul 11, 2025 | Dec 1, 2031 | Jun 5, 2026 | 57 | United States, Bulgaria +2 |
| NCT06963034 | NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia | PHASE3 | RECRUITING | 284 | — | — | May 8, 2025 | Oct 1, 2027 | Mar 6, 2026 | 21 | United States |
| NCT05545111 | Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia | PHASE2 | COMPLETED | 210 | — | — | Oct 4, 2022 | Jul 10, 2024 | Jul 11, 2025 | 15 | United States |
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
| Arm | Type | Description |
|---|---|---|
| NBI-1117568 | EXPERIMENTAL | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period. |
| Placebo | PLACEBO_COMPARATOR | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period. |
| Dose Level A | EXPERIMENTAL | Participant administered Dose Level A (6 weeks) |
| Dose Level B | EXPERIMENTAL | Participant administered Dose Level B (6 weeks) |
| Dose Level C | EXPERIMENTAL | Participant administered Dose Level C (6 weeks) |
| Dose Level D | EXPERIMENTAL | Participant administered Dose Level D (6 weeks) |
| Placebo Schedule | PLACEBO_COMPARATOR | Participant administered placebo (6 weeks) |
| Name | Type | Description |
|---|---|---|
| NBI-1117568 | DRUG | Oral capsules |
| Placebo | DRUG | Oral capsules |
Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. * Participant had the initial diagnosis of schiz...