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HNO Donor · 2 trials · 3 indications
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
| Arm | Type | Description |
|---|---|---|
| Placebo/BMS-986231/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Placebo/NTG/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/Placebo/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/BMS-986231/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/Placebo/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/NTG/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Part 1 Cohort 1 HNO Donor | EXPERIMENTAL | - |
| Placebo Part 1 Cohort 1 | PLACEBO_COMPARATOR | - |
| Part 2 Cohort 2 HNO Donor- low dose | EXPERIMENTAL | - |
| Part 2 Cohort 2 HNO Donor- high dose | EXPERIMENTAL | - |
| Placebo Part 2 Cohort 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| HNO Donor | DRUG | Infusion |
| Nitroglycerin (NTG) | DRUG | Infusion |
| Placebo | OTHER | Infusion |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less) * Stable guideline directed therapy for heart failure including oral diu...
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HNO Donor is an investigational small molecule being studied for the treatment of heart failure. It is a nitroxyl donor that has been evaluated in hospitalized patients with heart failure and in patients with heart failure and impaired systolic function. The drug is currently in Phase 2 clinical development.
HNO Donor is a nitroxyl (HNO) donor, meaning it releases nitroxyl, a reactive nitrogen species that can modulate cardiac function. Nitroxyl is believed to enhance myocardial contractility and vasodilation, which may be beneficial in heart failure. The drug is being developed to address reduced cardiac output and related symptoms.
HNO Donor is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for heart failure.
HNO Donor is in Phase 2 clinical development. It has completed two Phase 2 trials, with a total of 378 participants enrolled. The drug is not yet approved and remains investigational, meaning it has not been authorized for commercial use by regulatory authorities.
HNO Donor has been studied in two completed Phase 2 trials. The first, NCT03016325, evaluated 48-hour infusions in 329 hospitalized patients with heart failure. The second, NCT03357731, studied continuous infusions in 49 patients with heart failure and impaired systolic function. Both trials were randomized, double-blind, and controlled.
HNO Donor is a nitroxyl donor, not nitroxyl itself. It is a compound that releases nitroxyl (HNO) in the body. The drug is designed to deliver nitroxyl to exert its effects on the cardiovascular system, particularly in heart failure. It is not referred to by any other name in the available data.