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EDP-788 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| EDP-788 | EXPERIMENTAL | Single doses with dose escalation to continue in successive cohorts |
| Placebo | PLACEBO_COMPARATOR | Single dose with matching placebo |
| Name | Type | Description |
|---|---|---|
| EDP-788 | DRUG | EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses |
| Placebo | DRUG | Matching placebo capsules or matching suspension |
Key Inclusion Criteria: * In good general health * BMI between 18 - 32 kg/m2 * Women must be of non-childbearing potential (surgically sterilized) * Normal electrocardiogram * Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 8 - ...
EDP-788 is an investigational small molecule being studied for safety in normal volunteers. It is not approved for any disease and is in clinical development to evaluate its safety and pharmacokinetics after a single oral dose.
EDP-788 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA.
EDP-788 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.
EDP-788 has one completed Phase 1 clinical trial, NCT01999725, titled 'Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788.' The trial enrolled 80 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.
No, EDP-788 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not been approved for any use.