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MYK-461 · 4 trials · 4 indications
Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.
Incidence of adverse events
| Arm | Type | Description |
|---|---|---|
| Open Label | EXPERIMENTAL | MYK-461 |
| MYK-461 | EXPERIMENTAL | Oral Tablet x 28 days |
| Placebo | PLACEBO_COMPARATOR | Oral Tablet x 28 days |
| Name | Type | Description |
|---|---|---|
| MYK-461 | DRUG | - |
| Placebo | DRUG | Placebo comparator |
Key Inclusion Criteria: * Diagnosed with HCM (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with LV wall thickness ≥ 15 mm at time of initial diagnosis or ≥ 13 mm with a positive family history of HCM. * Age 18-70 * BMI 18-37kg/m2 * Documented LVEF ≥ 55%...
MYK-461 is an investigational small molecule being studied for the treatment of hypertrophic cardiomyopathy, including hypertrophic obstructive cardiomyopathy with left ventricular outflow tract obstruction. It has also been evaluated in healthy volunteers in early-phase clinical trials. The drug is in Phase 2 development and is not yet approved by regulatory authorities.
MYK-461 is a small molecule designed to modulate cardiac muscle contraction. While its specific molecular target is not publicly detailed in the available clinical trial information, it is being investigated for its effects on hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle.
MYK-461 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in patients with hypertrophic cardiomyopathy and in healthy volunteers.
MYK-461 is currently in Phase 2 clinical development. It has completed Phase 1 trials in healthy volunteers and patients with hypertrophic cardiomyopathy, and a Phase 2 open-label pilot study in patients with symptomatic hypertrophic obstructive cardiomyopathy has also been completed. The drug remains investigational and has not received FDA approval.
MYK-461 has been studied in four completed clinical trials. These include NCT02329184, a Phase 1 study in patients with hypertrophic cardiomyopathy; NCT02356289 and NCT02480296, Phase 1 single and multiple ascending dose studies in healthy volunteers; and NCT02842242, a Phase 2 open-label pilot study in patients with symptomatic hypertrophic obstructive cardiomyopathy and left ventricular outflow tract obstruction.
MYK-461 is an investigational drug that has been studied under this identifier in clinical trials. It is not stated in the available information whether MYK-461 is the same as mavacamten or any other named compound. The drug is being developed by Bristol-Myers Squibb for hypertrophic cardiomyopathy.