Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NBI-1065845
TAK-653 · 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...
Top 20 of 31 competitors
TAK-653 is an investigational small molecule being developed by Neurocrine Biosciences, Inc. (ticker NBIX) for depressive disorder. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved medicine.
TAK-653 is being investigated for depressive disorder, a psychiatric condition. The clinical work completed to date studied the drug in healthy adult volunteers rather than in patients with depression, so its use in depressive disorder remains investigational and unproven.
TAK-653 is being developed by Neurocrine Biosciences, Inc., which trades under the ticker NBIX. The company is the sponsor of the clinical program for the asset in depressive disorder.
TAK-653 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early-stage testing, and the drug is investigational rather than approved.
TAK-653 has been studied in one completed Phase 1 trial, NCT02561156, titled TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants. It enrolled 88 participants in the United Kingdom, was randomized, double blind, and controlled, and included healthy volunteers aged 18 years and older.
Yes. The completed Phase 1 study of TAK-653, NCT02561156, was conducted in healthy participants rather than in patients with depressive disorder. It was a randomized, double blind, controlled dose escalation study of single and multiple doses that enrolled 88 participants in the United Kingdom.