Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-305 · 3 trials · 2 indications
Percent change was calculated as \[(ALP at Week 12 - ALP at Baseline)/ALP at Baseline\] \*100. The participant was considered to have successfully achieved a 20% reduction in ALP if the result was ≤-20. The participant was considered to have successfully achieved ALP normalization if ALP was abnormal at Baseline and normal at Week 12.
| Arm | Type | Description |
|---|---|---|
| EDP-305 1 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 2.5 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects will take two tablets once a day orally for 12 weeks |
| EDP-305 and Oral Contraceptive | EXPERIMENTAL | - |
| Single arm EDP-305 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| EDP-305 1 mg | DRUG | Two tablets daily for 12 weeks |
| EDP-305 2.5 mg | DRUG | Two tablets daily for 12 weeks |
| Placebo | DRUG | Two tablets daily for 12 weeks |
| EDP-305 | DRUG | Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3 |
| Oral Contraceptive | DRUG | Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3 |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at...
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.