Approval Probability
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EDG-5506 · 3 trials · 9 indications
| Arm | Type | Description |
|---|---|---|
| Part A - AME | EXPERIMENTAL | Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers |
| Part B - aBA | EXPERIMENTAL | Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers |
| Treatment | EXPERIMENTAL | Drug: EDG-5506 |
| Healthy Volunteer: Single Ascending Dose | EXPERIMENTAL | Single oral ascending dose in healthy volunteers Interventions: Drug: EDG-5506 Drug: Placebo |
| Healthy Volunteer: Multiple Ascending Dose | EXPERIMENTAL | Multiple oral ascending doses in healthy volunteers Interventions: Drug: EDG-5506 Drug: Placebo |
| Becker Muscular Dystrophy: Multiple Ascending Dose | EXPERIMENTAL | Multiple oral ascending doses in adults with Becker muscular dystrophy Interventions: Drug: EDG-5506 Drug: Placebo |
| Name | Type | Description |
|---|---|---|
| EDG-5506 Tablet | DRUG | Single Oral Dose - Tablet |
| Radiolabeled EDG-5506 Suspension | DRUG | Single Oral Dose |
| Radiolabeled EDG-5506 Intravenous | DRUG | Single Intravenous Dose |
| EDG-5506 | DRUG | single oral dose |
| Placebo | DRUG | Placebo is administered orally as a single dose or once daily |
Inclusion Criteria: 1. For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive. 2. For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg. 3. In good health, determined by no clin...
EDG-5506 is an investigational small molecule being developed for muscular dystrophies, including Becker muscular dystrophy. It has been studied in healthy volunteers as well. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
EDG-5506 is being developed by Edgewise Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EWTX. The company is conducting clinical research on this investigational small molecule for muscular dystrophies.
EDG-5506 is in Phase 1 clinical development. It remains an investigational drug and has not been approved for any use. Clinical trials have been completed in healthy volunteers and in adults with Becker muscular dystrophy to assess safety, tolerability, and pharmacokinetics.
EDG-5506 has completed three Phase 1 clinical trials. NCT04585464 assessed safety, tolerability, and pharmacokinetics in healthy volunteers and Becker muscular dystrophy adults. NCT05492734 evaluated non-invasive dried blood sampling feasibility, and NCT05730842 studied absorption, metabolism, excretion, and absolute bioavailability in healthy volunteers.
EDG-5506 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information. It is being studied under this identifier by Edgewise Therapeutics across multiple Phase 1 studies.