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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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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.