Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-323 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| EDP-323, midazolam, caffeine and rosuvastatin | EXPERIMENTAL | Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days |
| EDP-323 and itraconazole interaction (Part 1) | EXPERIMENTAL | Subjects will receive EDP-323 and itraconazole on respective dosing days |
| EDP-323 and carbamazepine interaction (Part 2) | EXPERIMENTAL | Subjects will receive EDP-323 and carbamazepine on respective dosing days |
| EDP-323 and quinidine interaction (Part 3) | EXPERIMENTAL | Subjects will receive EDP-323 and quinidine on respective dosing days |
| EDP-323 and fluconazole interaction (Part 4) | EXPERIMENTAL | Subjects will receive EDP-323 and fluconazole on respective dosing days |
| EDP-323 SAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration |
| EDP-323 MAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days |
| EDP-323 SAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-323 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-323 | DRUG | Subjects will receive EDP-323 once daily on Days 5-15 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Days 1 and 12 |
| Caffeine | DRUG | Subjects will receive caffeine once daily on Days 1 and 12 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD Days 5-18 |
| carbamazepine | DRUG | Subjects will receive carbamazepine on Days 5 - 27 |
| Quinidine | DRUG | Subjects will receive quinidine on Days 5-12 |
| fluconazole | DRUG | Subjects will receive fluconazole on Days 5-18 |
| Placebo | DRUG | Placebo to match EDP-323, oral administration |
Inclusion Criteria: * An informed consent document signed and dated by the subject * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive * Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2 * Female subjects of childbearing pot...
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EDP-323 is an investigational small molecule being developed for the treatment of RSV infection, a respiratory illness caused by respiratory syncytial virus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
EDP-323 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug.
EDP-323 is in Phase 1 clinical development. All three completed trials for this drug were Phase 1 studies, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
EDP-323 has completed three Phase 1 clinical trials: NCT05587478, a study in healthy subjects; NCT06847464, a drug-drug interaction study with itraconazole, carbamazepine, quinidine, and fluconazole; and NCT06917508, a drug-drug interaction study with midazolam, caffeine, and rosuvastatin. All trials were conducted in the United States.
EDP-323 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with all completed trials being early-stage studies in healthy volunteers. The drug has not yet demonstrated efficacy in patients or received marketing authorization.