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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...
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NBI-1117568 is an investigational small molecule developed by Neurocrine Biosciences for psychiatric disorders. It is being studied in bipolar I disorder with current mania and in schizophrenia. The program includes five clinical trials, four of which are currently recruiting participants, with a combined planned enrollment of 1,938 adults.
NBI-1117568 is being evaluated for the treatment of schizophrenia and for bipolar I disorder with current mania. The schizophrenia program includes relapse prevention and long-term evaluation studies, while the bipolar I disorder program focuses on adults with current mania. It is investigational and has not been approved for any indication.
NBI-1117568 targets the M4 muscarinic acetylcholine receptor. It is a small molecule designed to act at M4, a receptor implicated in psychiatric and central nervous system conditions. This targeted mechanism distinguishes it from broadly acting antipsychotic agents and is the basis for its study in schizophrenia and bipolar I disorder.
NBI-1117568 is developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company is sponsoring the clinical program, including the Phase 2 bipolar I disorder study and the Phase 3 schizophrenia trials currently recruiting participants.
NBI-1117568 is in Phase 2 and Phase 3 clinical development. The bipolar I disorder with mania study is Phase 2, while three schizophrenia studies are Phase 3. The drug is investigational and has not been approved by the FDA for any indication. Five trials are registered, with four actively recruiting.
NBI-1117568 is being studied in five registered trials. These include NCT07288320 in bipolar I disorder with mania, NCT07227818 for schizophrenia relapse prevention, NCT07114874 for long-term schizophrenia evaluation, and NCT07105098 in inpatient adults with schizophrenia. The trials are randomized, double-blind, and placebo-controlled, with a combined planned enrollment of 1,938 participants.