Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NBI-1117568 · 6 trials · 3 indications
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...
NBI-1117568 is an investigational small molecule being developed for the treatment of schizophrenia and bipolar I disorder. It is currently in Phase 2 and Phase 3 clinical trials for schizophrenia, with studies also evaluating its use in bipolar I disorder. The drug is not yet approved by regulatory authorities.
NBI-1117568 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting multiple clinical trials for this investigational drug in schizophrenia and bipolar I disorder.
NBI-1117568 is in Phase 2 and Phase 3 clinical development. One Phase 2 trial in schizophrenia has been completed, and three Phase 3 trials are currently recruiting participants. The drug remains investigational and has not received FDA approval.
NBI-1117568 has four active clinical trials: NCT06963034, a Phase 3 study in inpatient adults with schizophrenia; NCT07114874, a long-term Phase 3 study in schizophrenia; NCT07227818, a Phase 3 relapse prevention study in schizophrenia; and NCT05545111, a completed Phase 2 trial in schizophrenia.
NBI-1117568 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.