Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NBI-1065845 · 6 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Open-label Treatment Period: NBI-1065845 | EXPERIMENTAL | Participants will be treated with NBI-1065845 during the open-label treatment period. |
| Randomized Double-blind Maintenance Period: NBI-1065845 | EXPERIMENTAL | Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period. |
| Randomized Double-blind Maintenance Period: Placebo | EXPERIMENTAL | Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period. |
| NBI-1065845 | EXPERIMENTAL | NBI-1065845 administered orally once a day. |
| Placebo | PLACEBO_COMPARATOR | Placebo identical in appearance to NBI-1065845 will be administered orally once a day. |
| NBI-1065845 Low Dose | EXPERIMENTAL | Participants will receive low-dose NBI-1065845 orally once a day. |
| NBI-1065845 High Dose | EXPERIMENTAL | Participants will receive high-dose NBI-1065845 orally once a day. |
| Name | Type | Description |
|---|---|---|
| NBI-1065845 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
Key Inclusion Criteria: * Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. * Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * Participant must have been taking oral antide...
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