Overview
Tavaborale is a novel, boron-based topical antifungal medication for the treatment of onychomycosis, a fungal infection of the nail and nail bed due to Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole functions by inhibiting Leucyl-tRNA synthetase, or LeuRS, an essential fungal enzyme required for protein synthesis and for the catalysis of ATP-dependent ligation of L-leucine to tRNA(Leu).
Background
Tavaborale is a novel, boron-based topical antifungal medication for the treatment of onychomycosis, a fungal infection of the nail and nail bed due to Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole functions by inhibiting Leucyl-tRNA synthetase, or LeuRS, an essential fungal enzyme required for protein synthesis and for the catalysis of ATP-dependent ligation of L-leucine to tRNA(Leu).
Indication
Indicated for the treatment of onychomycosis (a fungal infection) of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Associated Conditions
- Onychomycosis of the Toenails caused by Trichophyton mentagrophytes
- Onychomycosis of the Toenails caused by Trichophyton rubrum
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/01/23 | Phase 4 | Completed | |||
2008/05/19 | Phase 2 | Completed | |||
2008/05/19 | Phase 1 | Completed | |||
2008/05/19 | Phase 2 | Completed | |||
2008/05/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Padagis US LLC | 0574-0157 | TOPICAL | 43.5 mg in 1 mL | 1/11/2021 | |
| Viona Pharmaceuticals Inc | 72578-102 | TOPICAL | 43.5 mg in 1 mL | 4/12/2023 | |
| Cipla USA Inc. | 69097-686 | TOPICAL | 43.5 mg in 1 mL | 1/9/2024 | |
| Chartwell RX, LLC | 62135-663 | TOPICAL | 43.5 mg in 1 mL | 9/15/2023 | |
| Encube Ethicals Private Limited | 21922-020 | TOPICAL | 43.5 mg in 1 mL | 10/29/2020 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1397 | TOPICAL | 43.5 mg in 1 mL | 5/28/2019 | |
| Mayne Pharma Commercial LLC | 51862-690 | TOPICAL | 43.5 mg in 1 mL | 3/5/2024 | |
| Zydus Lifesciences Limited | 70771-1826 | TOPICAL | 43.5 mg in 1 mL | 4/12/2023 | |
| Bryant Ranch Prepack | 63629-8704 | TOPICAL | 43.5 mg in 1 mL | 2/23/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-467 | TOPICAL | 43.5 mg in 1 mL | 12/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||