Approval Probability
TA Base Rate
Adjusted LOA
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Bifonazole 1% · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bifonazole cream 1% | DRUG | 1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste |
| Placebo cream | DRUG | 1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste |
Inclusion Criteria: * Age of at least 18 years; * Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails); * Positive mycological findings (positive microscopy and positive culture with identifi...
Bifonazole 1% is an investigational small molecule being studied for the treatment of onychomycosis, a fungal infection of the nails. It is applied as a cream and is being evaluated in combination with nail ablation using urea paste. The drug is currently in Phase 3 clinical development.
Bifonazole 1% is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this antifungal treatment for onychomycosis.
Bifonazole 1% is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to assess its efficacy and safety in patients with onychomycosis, but it remains under investigation.
Bifonazole 1% has one completed Phase 3 clinical trial registered as NCT00781820. This randomized, double-blind, placebo-controlled study enrolled 693 participants with onychomycosis across Czechia, Germany, and Poland. The trial evaluated the comparative efficacy of bifonazole cream versus placebo after nail ablation with urea paste.
Bifonazole 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 membrane permeability and ultimately fungal cell death. The drug is applied topically as a cream to treat nail fungal infections.