Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 581 · 2 trials · 1 indication
Number and percent of subjects experiencing adverse events
Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
Summaries over time and/or changes from baseline over time in heart rate
Summaries over time and/or changes from baseline over time in respiratory rate
Summaries over time and/or changes from baseline over time in temperature
Summaries over time and/or changes from baseline over time in ECGs
Subjects' maximum change from baseline in QTc and the number and percentage of subjects in each group
Subjects' maximum post-baseline values and the number and percentage of subjects in each group
Summaries over time and/or changes from baseline over time in changes in Simpson Angus Scale (SAS) score
Summaries over time and/or changes from baseline over time in in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
Summaries over time and/or changes from baseline over time in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
| Arm | Type | Description |
|---|---|---|
| AMG 581 - Dose 1 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 2 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 3 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 4 | ACTIVE_COMPARATOR | - |
| Placebo - Dose 1 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 2 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 3 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 4 | PLACEBO_COMPARATOR | - |
| AMG 581/Midazolam - Drug Interaction | OTHER | - |
| Placebo | PLACEBO_COMPARATOR | - |
| AMG 581 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 581 | DRUG | Active drug |
| Placebo | DRUG | Placebo |
| Midazolam | DRUG | Interaction |
Inclusion Criteria: \- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history o...
AMG 581 is an investigational small molecule being developed for the treatment of schizophrenia or schizoaffective disorder. It is currently in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed, both in the United States.
AMG 581 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is in Phase 1 clinical development for schizophrenia or schizoaffective disorder.
AMG 581 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with a total enrollment of 122 participants.
AMG 581 has two completed Phase 1 trials: NCT02504476, a multiple ascending dose study in healthy subjects or subjects with schizophrenia or schizoaffective disorder, and NCT02567370, a single-ascending dose study with a food-effect cohort. Both trials were conducted in the United States.
AMG 581 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for schizophrenia or schizoaffective disorder. Two Phase 1 trials have been completed, but the drug remains in clinical development.