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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 Bipolar I Disorder and Schizophrenia. It is being studied in adults with bipolar I disorder with current mania and in adults with schizophrenia, including trials evaluating relapse prevention and long-term treatment.
NBI-1117568 targets the M4 muscarinic receptor. It is an investigational small molecule being developed by Neurocrine Biosciences for psychiatric conditions including Bipolar I Disorder and Schizophrenia.
NBI-1117568 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials of the drug in adults with schizophrenia and bipolar I disorder.
NBI-1117568 is in Phase 2 and Phase 3 clinical development. It is being studied in a Phase 2 trial for bipolar I disorder with mania and in multiple Phase 3 trials for schizophrenia. It is investigational and not yet approved by the FDA.
NBI-1117568 is being studied in several trials. NCT07288320 is a Phase 2 trial in bipolar I disorder with mania. NCT07227818 is a Phase 3 relapse prevention trial in schizophrenia. NCT07114874 is a long-term Phase 3 trial, and NCT07105098 is a Phase 3 inpatient trial in schizophrenia.
No alternative names for NBI-1117568 have been disclosed. The drug is identified solely by its development code NBI-1117568 in clinical trial registrations and company communications.