Approval Probability
TA Base Rate
Adjusted LOA
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EDG-15400 · 1 trial · 1 indication
Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF
| Arm | Type | Description |
|---|---|---|
| EDG-15400 25 mg | EXPERIMENTAL | - |
| EDG-15400 50 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EDG-15400 25 mg | DRUG | EDG-15400 administered orally, once daily |
| Placebo to match EDG-15400 25 mg or 50 mg | DRUG | Placebo administered orally, once daily |
| EDG-15400 50 mg | DRUG | EDG-15400 administered orally, once daily |
Inclusion Criteria: * Males and nonpregnant females, ages ≥30 to \<85 years of age at screening * Body weight ≥ 45 kg, BMI \< 40 * LVEF ≥ 50% * Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines f...
EDG-15400 is an investigational small molecule developed by Edgewise Therapeutics, Inc. for heart failure with preserved ejection fraction, a form of heart failure in which the heart's pumping function appears normal but it struggles to fill properly. It is in Phase 2 clinical development and has not been approved by the FDA.
EDG-15400 is being studied as a treatment for heart failure with preserved ejection fraction, or HFpEF. The Phase 2 EQUINOX-HFpEF trial is evaluating the drug in adults aged 30 years and older with this condition. It remains investigational and is not approved for any use.
EDG-15400 targets a cardiac sarcomeric protein, a component of the heart's contractile machinery. The specific molecular target has not been disclosed. Modulating sarcomeric function is the intended approach for addressing the impaired cardiac filling that characterizes heart failure with preserved ejection fraction.
EDG-15400 is being developed by Edgewise Therapeutics, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol EWTX. Edgewise is the sponsor of the Phase 2 EQUINOX-HFpEF study evaluating the drug in heart failure with preserved ejection fraction.
EDG-15400 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 2 EQUINOX-HFpEF trial is currently recruiting participants and is the only clinical trial of EDG-15400 listed for the program.
EDG-15400 is being evaluated in the Phase 2 EQUINOX-HFpEF trial, registered as NCT07795814. The study is titled A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction. It is recruiting in the United States, is randomized, double blind, and placebo controlled, and plans to enroll 90 participants.