Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-297 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| EDP-297 SAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration |
| EDP-297 MAD Cohorts | EXPERIMENTAL | EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days |
| EDP-297 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily in one single administration |
| EDP-297 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral solution, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-297 | DRUG | EDP-297 Oral solution |
| Placebo | DRUG | placebo to match EDP-297 |
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. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * Pregnant or nursing fe...
EDP-297 is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. It is intended to address the metabolic condition characterized by fat accumulation in the liver, inflammation, and scarring. The drug is currently in clinical development and has not been approved for any use.
EDP-297 is a small molecule designed to target pathways involved in nonalcoholic steatohepatitis (NASH) with liver fibrosis. While the specific molecular target has not been disclosed, the drug is being studied for its potential to modify the disease process in this metabolic liver condition.
EDP-297 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ENTA. The company is conducting clinical research on this investigational small molecule for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis.
EDP-297 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received FDA approval and is still undergoing clinical evaluation to assess its safety and tolerability in humans.
EDP-297 has been studied in one completed Phase 1 clinical trial, identified as NCT04559126. This randomized, double-blind, placebo-controlled study enrolled 82 healthy volunteers in the Netherlands and evaluated the safety and tolerability of the drug. The trial is now completed.
EDP-297 is not known to have any alternative names. It is a distinct investigational compound developed by Enanta Pharmaceuticals for nonalcoholic steatohepatitis (NASH) with liver fibrosis. No other names or aliases have been associated with this drug in clinical development.