Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-EDG-7500
EDG-7500 · 3 trials · 3 indications
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.
| 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. |
| 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 |
| Name | Type | Description |
|---|---|---|
| EDG-7500 | DRUG | Liquid suspension formulation of EDG-7500 |
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 developed by Edgewise Therapeutics, Inc. (ticker: EWTX). It is being studied in hepatic impairment, renal impairment, and hypertrophic cardiomyopathy. It is a Phase 1/Phase 2 clinical-stage candidate and has not been approved by the FDA.
EDG-7500 is being evaluated for hepatic impairment, renal impairment, and hypertrophic cardiomyopathy. Clinical trials have enrolled adults with these conditions. It remains investigational and is not approved for any indication.
EDG-7500 targets the cardiac sarcomere, a protein complex that drives heart muscle contraction. By acting on the cardiac sarcomere, the drug is designed to modulate contractility, which is relevant to hypertrophic cardiomyopathy.
EDG-7500 is being developed by Edgewise Therapeutics, Inc., which trades on the Nasdaq under the ticker EWTX. The company sponsors the clinical trials evaluating the drug.
EDG-7500 is in Phase 1 and Phase 2 clinical development. A Phase 2 trial in hypertrophic cardiomyopathy is active but not recruiting, while two Phase 1 trials in hepatic and renal impairment have been completed. It is not FDA approved.
EDG-7500 has been studied in three clinical trials: NCT07324616 in adults with hepatic impairment, NCT07034768 in people with renal impairment, and NCT06347159 (CIRRUS-HCM) in adults with hypertrophic cardiomyopathy. The first two are completed Phase 1 studies; CIRRUS-HCM is an active Phase 2 trial.
Yes, [14C]-EDG-7500 is an alternative name for EDG-7500. The [14C] label denotes a carbon-14 radiolabeled version used in certain studies, but it refers to the same investigational drug candidate.