Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Econazole Nitrate, 1% · 1 trial · 1 indication
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
| Arm | Type | Description |
|---|---|---|
| Test | EXPERIMENTAL | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Reference Standard | ACTIVE_COMPARATOR | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| Econazole Nitrate Cream, 1% | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy male or non-pregnant, non-lactating female ≥ 18 years of age. * Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hype...
Econazole Nitrate, 1% is a small molecule used for the treatment of tinea pedis, commonly known as athlete's foot. It is a topical antifungal cream being developed by Viatris Inc. for this infectious disease indication.
Econazole Nitrate, 1% is an antifungal agent that works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. This disruption leads to increased fungal cell permeability and ultimately fungal cell death, making it effective against dermatophytes that cause tinea pedis.
Econazole Nitrate, 1% is being developed by Viatris Inc., a global healthcare company. Viatris is publicly traded on the NASDAQ under the ticker symbol VTRS.
Econazole Nitrate, 1% is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its therapeutic equivalence and safety in treating tinea pedis.
Econazole Nitrate, 1% has one completed Phase 3 clinical trial, identified as NCT03129321. This randomized, double-blind, placebo-controlled study enrolled 876 participants aged 18 years and older to assess the therapeutic equivalence and safety of two econazole nitrate cream 1% products in treating tinea pedis.