Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-494 · 1 trial · 1 indication
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine). Administered to healthy volunteers and multiple doses of EDP-494 administered to healthy volunteers and subjects with Chronic Hepatitis C (CHC) genotype 1 and 3 infection
| Arm | Type | Description |
|---|---|---|
| EDP-494 SAD Cohorts | EXPERIMENTAL | EDP-494, oral 50 mg, 100mg, 200mg, 400mg and 800 mg, capsules, once daily in one single administration |
| EDP-494 MAD/POC Cohorts | EXPERIMENTAL | EDP-494, oral 200mg, 400mg and 800 mg, capsules, once daily for 14 days |
| EDP-494 SAD Placebo Cohort | PLACEBO_COMPARATOR | - |
| EDP-494 MAD/POC Placebo Cohort | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EDP-494 | DRUG | 10, 100 and 200 mg capsules |
| Placebo | DRUG | placebo to match EDP-494 |
Inclusion Criteria for Healthy Volunteers (SAD and MAD Phases): * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. * All male participants who have not had a vasectomy must use effective co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
EDP-494 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
EDP-494 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating Hepatitis C.
EDP-494 is in Phase 1 clinical development. A Phase 1 study, EDP-494-001, has been completed, which enrolled 100 participants, including healthy volunteers and patients with Hepatitis C. The drug remains investigational and is not yet approved for commercial use.
EDP-494 has one completed Phase 1 clinical trial registered as NCT02652377, titled "EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients." The study was conducted in New Zealand, enrolled 100 participants aged 18 years and older, and was randomized, double-blind, and placebo-controlled.
No, EDP-494 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Hepatitis C. The completed Phase 1 trial was designed to evaluate safety and tolerability, and further studies would be needed before any regulatory approval could be considered.