Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-EDG-7500
EDG-7500 · 6 trials · 6 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 |
| Human AME | EXPERIMENTAL | - |
| 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 |
| [14C]-EDG-7500 | DRUG | Oral liquid suspension |
| 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 developed by Edgewise Therapeutics, Inc. (ticker: EWTX). It is being studied in Phase 1 clinical trials in healthy adult participants and in people with hepatic impairment, renal impairment, and hypertrophic cardiomyopathy. It has not been approved by the FDA and remains in clinical development.
EDG-7500 targets the cardiac sarcomere, the contractile protein structure of heart muscle cells. By acting on this protein target, the small molecule is designed to modulate cardiac sarcomere function. This mechanism underlies its study in hypertrophic cardiomyopathy, a condition involving abnormal thickening and contraction of the heart muscle.
EDG-7500 is developed by Edgewise Therapeutics, Inc., which trades under the ticker symbol EWTX. The company is running the clinical development program for the drug, including Phase 1 studies in healthy volunteers and in participants with hepatic impairment, renal impairment, and hypertrophic cardiomyopathy.
EDG-7500 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes completed studies in healthy adult participants, people with hepatic impairment, people with renal impairment, and a healthy volunteer study of orally administered [14C]-EDG-7500.
EDG-7500 has been studied in four Phase 1 trials: NCT07456059 in Caucasian and Japanese adults, NCT07324616 in adults with hepatic impairment, NCT07034768 in people with renal impairment, and NCT06738836, which evaluated the absorption, metabolism, and excretion of orally administered [14C]-EDG-7500. All four trials are listed as completed, with total enrollment of 84 participants.
Yes, [14C]-EDG-7500 is a carbon-14 radiolabeled form of EDG-7500 used in a Phase 1 absorption, metabolism, and excretion study, NCT06738836. That trial enrolled 8 healthy male volunteers and was conducted in the United States. The radiolabel allows researchers to track how the drug is absorbed, metabolized, and excreted by the body.