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NBI-1070770 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| NBI-1070770: Low Dose | EXPERIMENTAL | Participants will receive low-dose NBI-1070770. |
| NBI-1070770: Medium Dose | EXPERIMENTAL | Participants will receive medium-dose NBI-1070770. |
| NBI-1070770: High Dose | EXPERIMENTAL | Participants will receive high-dose NBI-1070770. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| Name | Type | Description |
|---|---|---|
| NBI-1070770 | DRUG | Suspension for oral administration |
| Placebo | DRUG | Suspension for oral administration |
Key Inclusion Criteria: Participants must meet all of the following inclusion criteria: * Primary diagnosis of recurrent MDD or persistent MDD. * Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior ...
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NBI-1070770 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adults with MDD to evaluate its efficacy and safety.
NBI-1070770 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Major Depressive Disorder.
NBI-1070770 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for its efficacy and safety in treating Major Depressive Disorder.
NBI-1070770 has one completed clinical trial, registered as NCT06267846, titled 'A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 73 participants in the United States.
No, NBI-1070770 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval and remains under clinical investigation.