Tavaborole

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).

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
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents	2018/01/23	NCT03405818	Phase 4	Completed	Pfizer
Cumulative Irritation Test	2008/05/19	NCT00680095	Phase 1	Completed	Pfizer
Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis	2008/05/19	NCT00680134	Phase 2	Completed	Pfizer
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)	2008/05/19	NCT00680160	Phase 2	Completed	Pfizer
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)	2008/05/19	NCT00679601	Phase 2	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tavaborole	Padagis US LLC	0574-0157	TOPICAL	43.5 mg in 1 mL	1/11/2021
Tavaborole	Viona Pharmaceuticals Inc	72578-102	TOPICAL	43.5 mg in 1 mL	4/12/2023
TAVABOROLE	Cipla USA Inc.	69097-686	TOPICAL	43.5 mg in 1 mL	1/9/2024
Tavaborole	Chartwell RX, LLC	62135-663	TOPICAL	43.5 mg in 1 mL	9/15/2023
Tavaborole	Encube Ethicals Private Limited	21922-020	TOPICAL	43.5 mg in 1 mL	9/15/2025
Tavaborole	Encube Ethicals, Inc.	21922-020	TOPICAL	43.5 mg in 1 mL	9/15/2025
TAVABOROLE	Taro Pharmaceuticals U.S.A., Inc.	51672-1397	TOPICAL	43.5 mg in 1 mL	5/28/2019
tavaborole	Mayne Pharma Commercial LLC	51862-690	TOPICAL	43.5 mg in 1 mL	3/5/2024
Tavaborole	Zydus Lifesciences Limited	70771-1826	TOPICAL	43.5 mg in 1 mL	4/12/2023
Tavaborole	Bryant Ranch Prepack	63629-8704	TOPICAL	43.5 mg in 1 mL	2/23/2022

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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