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BMS-986259 · 3 trials · 3 indications
Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) \<85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP \<90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
| Arm | Type | Description |
|---|---|---|
| BMS-986259 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm A: Normal Renal Function | EXPERIMENTAL | - |
| Arm B: Mild Renal Impairment | EXPERIMENTAL | - |
| Arm C: Moderate Renal Impairment | EXPERIMENTAL | - |
| Arm D: Severe Renal Impairment | EXPERIMENTAL | - |
| Part A SAD - A1 Cohort | EXPERIMENTAL | Single Ascending Dose |
| Part A SAD - A2 Cohort | EXPERIMENTAL | Single Ascending dose |
| Part A SAD- A3 Cohort | EXPERIMENTAL | Single Ascending dose |
| Part A SAD- A4 Cohort | EXPERIMENTAL | Single Ascending dose |
| Part A SAD - A5 Cohort | EXPERIMENTAL | Single Ascending dose |
| Part A SAD- A6 Cohort | EXPERIMENTAL | Single Ascending dose |
| Part B MAD- B1 Cohort | EXPERIMENTAL | Multiple Ascending Dose |
| Part B MAD - B2 Cohort | EXPERIMENTAL | Multiple Ascending Dose |
| Part B MAD - B3 Cohort | EXPERIMENTAL | Multiple Ascending Dose |
| Part B MAD - B4 Cohort | EXPERIMENTAL | Multiple Ascending Dose |
| Part C JMAD - C1 Cohort | EXPERIMENTAL | Japanese Multiple Ascending Dose |
| Part C JMAD - C2 Cohort | EXPERIMENTAL | Japanese Multiple Ascending Dose |
| Part C JMAD - C3 Cohort | EXPERIMENTAL | Japanese Multiple Ascending Dose |
| Name | Type | Description |
|---|---|---|
| BMS-986259 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
| P-Aminohippurate | DIAGNOSTIC_TEST | Diagnostic Agent |
| Iohexol | DIAGNOSTIC_TEST | Diagnostic Agent |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants currently hospitalized for acute decompensated heart failure (ADHF) * Participants must be hemodynamically stable, as assessed by the investigat...
BMS-986259 is an investigational small molecule being studied for acute decompensated heart failure, renal failure, and in healthy participants. It is in clinical development by Bristol-Myers Squibb. The drug has completed Phase 1 and Phase 2 trials, but it is not approved and remains under investigation.
BMS-986259 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of the drug in healthy participants, in participants with renal failure, and in participants with post-acute decompensated heart failure.
BMS-986259 is in Phase 2 clinical development. A Phase 2 study of the drug in participants with post-acute decompensated heart failure has been completed. Earlier Phase 1 trials in healthy participants and in participants with renal failure have also been completed. The drug is investigational and not yet approved.
BMS-986259 has been studied in three completed clinical trials. NCT04008992 was a Phase 1 ascending dose study in healthy participants. NCT04237831 was a Phase 1 study in participants with various levels of kidney function. NCT04318093 was a Phase 2 study in participants with post-acute decompensated heart failure.
BMS-986259 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. The drug is still in clinical development for acute decompensated heart failure and related conditions, and its safety and efficacy have not been established for regulatory approval.