Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDG-7500 · 5 trials · 5 indications
Area under the plasma concentration time-curve from time zero to the last measured concentration
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Area under the concentration-time curve during the dosing interval
Maximum plasma concentration observed
Maximum plasma concentration at steady state determined directly from the concentration-time profile
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-last)
Area under the plasma concentration time-curve from zero to extrapolated infinite time (AUC0-inf)
The time measured for the plasma concentration to decrease by one half.
To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses
| Arm | Type | Description |
|---|---|---|
| Part A: EDG-7500 Single Dose | EXPERIMENTAL | - |
| Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy | EXPERIMENTAL | EDG-7500 once daily for up to 28 days. |
| Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy | EXPERIMENTAL | EDG-7500 once daily for up to 28 days. |
| Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy | EXPERIMENTAL | EDG-7500 daily for up to 24 months in new participants and participants who have completed Part B or C. |
| Cohort 1 - Healthy Japanese Adults | EXPERIMENTAL | Single and Multiple Dose EDG-7500 |
| Cohort 2 - Healthy Japanese Adults | EXPERIMENTAL | Single and Multiple Dose EDG-7500 |
| Cohort 3 - Healthy Caucasian Adults | EXPERIMENTAL | Single and Multiple Dose EDG-7500 |
| Healthy Adults | EXPERIMENTAL | - |
| Mild Hepatic Impairment | EXPERIMENTAL | - |
| Moderate Hepatic Impairment | EXPERIMENTAL | - |
| Healthy Volunteers | EXPERIMENTAL | - |
| Severe Renal Impairment | EXPERIMENTAL | - |
| Moderate Renal Impairment | EXPERIMENTAL | - |
| Mild Renal Impairment | EXPERIMENTAL | This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment |
| Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose | EXPERIMENTAL | Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years |
| Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses | EXPERIMENTAL | Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years |
| Part D: Healthy Volunteer Food Effect and Relative Bioavailability | EXPERIMENTAL | Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation |
| Name | Type | Description |
|---|---|---|
| EDG-7500 | DRUG | Liquid suspension formulation of EDG-7500 |
| Placebo | DRUG | Placebo is administered orally once daily |
Key Inclusion Criteria: * Male or nonpregnant female, age ≥18 years to \<85 years. * Body mass index (BMI) ≥18 to \<35 kg/m2; weight ≥50 kg at Screening (BMI ≥ 18 to \< 40 kg/m2 is permitted for participants \< 50 years). * Diagnosed with hypertrophic cardiomyopathy at the time of Screening consist...
EDG-7500 is an investigational small molecule being developed by Edgewise Therapeutics for hypertrophic cardiomyopathy, a condition of thickened heart muscle. It is also being studied in healthy volunteers and in people with renal or hepatic impairment to evaluate how the body processes the drug.
EDG-7500 targets the cardiac sarcomere, the protein machinery in heart muscle cells responsible for contraction. By modulating this target, the drug aims to address the underlying dysfunction in hypertrophic cardiomyopathy.
EDG-7500 is being developed by Edgewise Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol EWTX.
EDG-7500 is in Phase 2 clinical development for hypertrophic cardiomyopathy, with an active Phase 2 trial (CIRRUS-HCM) that is not yet recruiting. It has also completed Phase 1 trials in healthy volunteers and in people with renal impairment.
EDG-7500 has been studied in several clinical trials, including NCT06011317 in healthy adults, NCT06347159 in adults with hypertrophic cardiomyopathy (CIRRUS-HCM), NCT07034768 in people with renal impairment, and NCT07456059 in Caucasian and Japanese adults.
Yes, EDG-7500 is the same as EDG-7500. The drug is referred to by the name EDG-7500 in clinical trial records and by the developer Edgewise Therapeutics.