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Also known as TAK-653
NBI-1065845 · 7 trials · 2 indications
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
| 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. |
| Part 1 Cohort 1: TAK-653 0.3 mg | EXPERIMENTAL | TAK-653 0.3 milligram (mg), tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 2: TAK-653 1.0 mg | EXPERIMENTAL | TAK-653 1.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 3: TAK-653 3.0 mg | EXPERIMENTAL | TAK-653 3.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 4: TAK-653 5.0 mg | EXPERIMENTAL | TAK-653 5.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 5: TAK-653 9.0 mg | EXPERIMENTAL | TAK-653 9.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 6: TAK- 653 18 mg | EXPERIMENTAL | TAK-653 18 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. Dose escalation to be decided (TBD) based on safety, tolerability, and available PK and pharmacodynamics (PD) data from previous cohorts. |
| Part 1 Additional Cohorts: TAK- 653 Placebo | EXPERIMENTAL | TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Cohort 1: TAK-653 0.3 mg | EXPERIMENTAL | TAK-653 0.3 mg, tablet, orally, once on Day 1, and once daily (QD) from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 2: TAK-653 1.0 mg | EXPERIMENTAL | TAK-653 1.0 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 3: TAK-653 3.0 mg | EXPERIMENTAL | TAK-653 3.0 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 4: TAK-653 6 mg | EXPERIMENTAL | TAK-653 6 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Cohort 5: TAK-653 9 mg | EXPERIMENTAL | TAK-653 9 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Additional Cohorts: TAK-653 Placebo | EXPERIMENTAL | TAK-653 placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Name | Type | Description |
|---|---|---|
| NBI-1065845 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
| TAK-653 Placebo | DRUG | TAK-653 placebo-matching tablets. |
| TAK-653 | DRUG | TAK-653 tablets. |
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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NBI-1065845 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD) in adults. It is being studied as an adjunctive treatment, meaning it is added to existing antidepressant therapy. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
NBI-1065845 targets the AMPA receptor, a type of glutamate receptor in the brain. By modulating this receptor, the drug is believed to enhance glutamatergic signaling, which may contribute to its antidepressant effects. This mechanism is being investigated in clinical trials for Major Depressive Disorder.
NBI-1065845 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NBIX. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety as an adjunctive treatment for Major Depressive Disorder.
NBI-1065845 is currently in Phase 3 clinical development. It has completed a Phase 2 trial (NCT05203341) and has three ongoing Phase 3 trials, including studies for adjunctive treatment, long-term safety, and maintenance of effect. The drug remains investigational and has not received FDA approval.
NBI-1065845 has one completed Phase 2 trial (NCT05203341) and three recruiting Phase 3 trials: NCT06911112 (adjunctive efficacy and safety), NCT06966401 (long-term safety and tolerability), and NCT07196501 (maintenance of effect). These trials enroll adults with Major Depressive Disorder across multiple countries.
NBI-1065845 is the sole name provided for this investigational compound. No alternative names or brand names have been disclosed in the available clinical trial information. The drug is being studied exclusively under this identifier in trials for Major Depressive Disorder.