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BMS-986511 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BMS-986511: Dose A | EXPERIMENTAL | - |
| BMS-986511: Dose B | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986511 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
Inclusion Criteria: * Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview. * Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale. * Participant must have current MDE duration \>12 weeks at screening. * O...
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BMS-986511 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD) in adults. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a randomized, double-blind, controlled clinical trial.
BMS-986511 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting a Phase 2 clinical trial of BMS-986511 in adults with Major Depressive Disorder.
BMS-986511 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is designed to evaluate the drug in adults with Major Depressive Disorder.
BMS-986511 is being studied in a Phase 2 clinical trial registered as NCT07772531, titled "A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder." The trial is expected to enroll 200 participants in the United States and Czechia, and is currently not yet recruiting.
No, BMS-986511 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. The drug has not completed clinical trials or received marketing authorization from the FDA or other regulatory bodies.