Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-514 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| EDP-514 and Itraconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-514 and Carbamazepine interaction (Part 2) | EXPERIMENTAL | - |
| EDP-514 and Quinidine interaction (Part 3) | EXPERIMENTAL | - |
| EDP-514 HBV MAD Cohorts | EXPERIMENTAL | EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days. |
| EDP-514 HBV MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 28 days. |
| EDP-514 HV SAD Cohorts | EXPERIMENTAL | EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration |
| EDP-514 HV MAD Cohorts | EXPERIMENTAL | EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days |
| EDP-514 HV SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-514 HV MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-514 | DRUG | Subjects will receive EDP-514 on Days 1 and 14 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD for 14 days |
| Carbamazepin | DRUG | Subjects will receive carbamazepine BID for 23 days |
| Quinidine | DRUG | Subjects will receive quinidine BID for 8 days |
| Placebo | DRUG | Placebo to match EDP-514 |
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 55 years, inclusive * Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of...
EDP-514 is an investigational small molecule being developed for the treatment of chronic hepatitis B virus (HBV) infection. It is currently in Phase 1 clinical development and has not been approved by the FDA. Studies have evaluated it in healthy subjects and in patients with chronic HBV infection.
EDP-514 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in available information. It is being studied for its potential to treat chronic hepatitis B virus infection, but the exact mechanism of action is not publicly detailed.
EDP-514 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The company has conducted Phase 1 clinical trials of EDP-514 in healthy volunteers and patients with chronic HBV infection.
EDP-514 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All completed trials for EDP-514 are Phase 1 studies, including those in healthy subjects and in patients with chronic hepatitis B virus infection.
EDP-514 has been studied in three completed Phase 1 trials: NCT04008004 in healthy subjects and chronic HBV patients in the US and Canada, NCT04470388 in untreated chronic HBV patients in Hong Kong and Taiwan, and NCT04783753, a drug-drug interaction study in healthy subjects in the US.
EDP-514 is a distinct investigational small molecule developed by Enanta Pharmaceuticals. No alternative names have been reported for this compound. It is being studied specifically for chronic hepatitis B virus infection and is not known to be identical to any other approved or investigational hepatitis B therapy.