Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EcoNail · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| EcoNail™ | EXPERIMENTAL | econazole 5%/SEPA® 18% nail lacquer |
| Name | Type | Description |
|---|---|---|
| EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) | DRUG | nail lacquer applied daily for 48 weeks |
Inclusion Criteria: * Subjects who are men and women greater than or equal to 18 years of age and less than or equal to 65 years of age. * Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically sterile, have a partner with a vasectomy, or routinely using an acceptable...
EcoNail is an investigational small molecule being developed for the treatment of onychomycosis, a fungal infection of the nail. It is currently in Phase 2 clinical development and has not been approved by the FDA.
EcoNail is being developed by Abeona Therapeutics Inc. (NASDAQ: ABEO). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for onychomycosis.
EcoNail is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug has received orphan drug designation.
EcoNail has one completed Phase 2 clinical trial, NCT00385502, which evaluated its safety and efficacy in treating fungus infections of the great toenail. The trial enrolled 40 participants in the United States and was not randomized or blinded.
No, EcoNail is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for onychomycosis. It has received orphan drug designation from the FDA, but it has not completed the approval process.