TAVABOROLE · ENCUBE
Tavaborole is a topical oxaborole antifungal indicated for the treatment of onychomycosis of the toenails caused by *Trichophyton rubrum* or *Trichophyton mentagrophytes*. It is applied directly to the affected nail plate.
How TAVABOROLE Works
Tavaborole is an oxaborole antifungal that inhibits fungal protein synthesis. It specifically inhibits aminoacyl-transfer RNA (tRNA) synthetase, specifically leucyl-tRNA synthetase (LeuRS). This inhibition prevents the ligation of leucine to tRNA, thereby halting fungal protein synthesis and inhibiting cell growth.
Details
- Status
- Prescription
- First Approved
- 2014-07-07
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION
TAVABOROLE Approval History
What TAVABOROLE Treats
1 indicationsTAVABOROLE is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Onychomycosis
TAVABOROLE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TAVABOROLE FDA Label Details
Indications & Usage
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes .
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KERYDIN
Full clinical data, patents, trials, and competitive landscape for tavaborole.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.