Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP 305 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Mild hepatic impairment group | EXPERIMENTAL | - |
| Moderate hepatic impairment group | EXPERIMENTAL | - |
| Matching healthy control group | EXPERIMENTAL | Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI |
| EDP 305 SAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP 305 MAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days |
| EDP 305 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily in one single administration |
| EDP 305 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP 305 | DRUG | Each subject will receive a single dose of EDP 305 on Day 1. |
| Placebo | DRUG | placebo to match EDP 305 |
Inclusion Criteria: * Able to understand and willing to sign the ICF and able to comply with the study restrictions * Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent * Female subjects must be non-childbearing potential Additional criteria for hepaticall...
EDP 305 is an investigational small molecule being developed for metabolic conditions, including nonalcoholic steatohepatitis (NASH), primary biliary cholangitis, and presumptive NAFLD. It has been studied in clinical trials for these indications, though it remains in clinical development and is not approved.
EDP 305 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The company has sponsored clinical trials of EDP 305 in patients with liver-related conditions.
EDP 305 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated the drug in primary biliary cholangitis, while Phase 1 trials assessed safety and drug interactions. All listed trials are completed, and EDP 305 is investigational.
EDP 305 has been studied in several completed trials, including NCT03207425 in mild and moderate hepatic impairment, NCT03394924 in primary biliary cholangitis, NCT03748628 an absorption and metabolism study, and NCT03783897 a drug-drug interaction study with oral contraceptives.
Yes, EDP 305 is the same as EDP-305. The drug name is written with or without a hyphen in clinical trial records and publications. Both refer to the same investigational compound developed by Enanta Pharmaceuticals.