Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07196501 | A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | PHASE3 | RECRUITING | 550 | — | — | Aug 18, 2025 | Jul 1, 2028 | Mar 19, 2026 | 45 | United States, Australia +9 |
| NCT06963021 | NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | PHASE3 | RECRUITING | 200 | — | — | May 30, 2025 | Jul 1, 2027 | Apr 15, 2026 | 30 | United States, Belgium +5 |
| NCT06966401 | Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | PHASE3 | RECRUITING | 850 | — | — | Apr 16, 2025 | May 1, 2030 | Apr 23, 2026 | 87 | United States, Belgium +14 |
| NCT06911112 | NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | PHASE3 | RECRUITING | 200 | — | — | Mar 31, 2025 | Jul 1, 2027 | Dec 1, 2025 | 10 | United States |
| NCT06786624 | Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | PHASE3 | RECRUITING | 200 | — | — | Jan 22, 2025 | Jul 1, 2027 | Oct 29, 2025 | 18 | United States |
| NCT05203341 | Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD) | PHASE2 | COMPLETED | 183 | — | — | Feb 21, 2022 | Feb 21, 2024 | Jan 15, 2025 | 41 | United States, Bulgaria +4 |
| 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...