Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986434, MYK-491
Danicamtiv · 3 trials · 2 indications
Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs).
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to the corresponding period.
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to first randomized dose.
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Number of participants with clinically significant laboratory abnormalities.
Number of participants with clinically significant physical examinations abnormalities.
| Arm | Type | Description |
|---|---|---|
| Danicamtiv + Midazolam | EXPERIMENTAL | - |
| Part 1/SAD and Part 2/MAD - drug | OTHER | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
| Part 1/SAD and Part 2/MAD - placebo | OTHER | Part 1/SAD: Crossover, Single ascending dose of MYK-491/placebo Part 2/MAD: Parallel, multiple ascending dose of MYK-491/placebo |
| Single oral dose of MYK-491 | EXPERIMENTAL | single-dose, oral suspension |
| Single oral dose of placebo | PLACEBO_COMPARATOR | single-dose, oral suspension |
| Name | Type | Description |
|---|---|---|
| Danicamtiv | DRUG | Specified dose on specified days |
| Midazolam | DRUG | Specified dose on specified days |
| MYK-491 | DRUG | Single Ascending Dose and Multiple Ascending Dose of MYK-491 |
| Placebo | DRUG | Single Ascending Dose and Multiple Ascending Dose of placebo |
| MYK-491 or placebo | DRUG | Oral suspension |
Inclusion Criteria: * Ambulatory participants with stable HFrEF due to any etiology. * Body mass index (BMI) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive. * Documented left ventricular ejection fraction (LVEF) 15% to 45% (on 2 occasions), including at least once during Screenin...
Danicamtiv is an investigational small molecule developed by Bristol-Myers Squibb Company (ticker: BMY) for heart failure with reduced ejection fraction. It is a cardiac myosin activator and remains in Phase 1 clinical development. It has not been approved by the FDA.
Danicamtiv is being studied for heart failure with reduced ejection fraction, a condition in which the heart muscle pumps blood less effectively. The clinical work to date has focused on how the drug behaves in participants with stable heart failure rather than on confirmatory efficacy outcomes.
Danicamtiv targets cardiac myosin proteins, specifically MYH7, MYH6, MYH7B, MYL3, MYL2, and MYL7. It acts as an activator of these targets. By acting on cardiac myosin, the drug is designed to influence the contractile machinery of heart muscle cells.
Danicamtiv is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor of the clinical program evaluating the drug in heart failure with reduced ejection fraction.
Danicamtiv is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The completed Phase 1 study enrolled 13 participants with stable heart failure and was conducted in the United States.
Danicamtiv has been evaluated in one clinical trial, NCT05952089, titled a study to assess the effect of danicamtiv on the drug levels of midazolam in participants with stable heart failure. That Phase 1 trial is completed, enrolled 13 participants, and was an uncontrolled study in the United States.