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Int J Toxicol ; 33(5): 419-27, 2014.
Article in English | MEDLINE | ID: mdl-25201897

ABSTRACT

Tavaborole, a cyclized boronic acid, has been approved by the Food and Drug Administration for the topical treatment of toenail onychomycosis. This novel, low-molecular-weight pharmaceutical compound has broad-spectrum antifungal activity against dermatophytes, yeasts, and molds responsible for the disease. Tavaborole was tested in 2-year carcinogenicity studies in mice (once daily dermal administration) and rats (once daily by oral gavage) as part of the extensive nonclinical safety program. There was no evidence of tavaborole-related neoplasms observed in either study. Based on the data gathered from these 2 carcinogenicity studies, tavaborole is considered noncarcinogenic.


Subject(s)
Antifungal Agents/toxicity , Boron Compounds/toxicity , Bridged Bicyclo Compounds, Heterocyclic/toxicity , Carcinogens/toxicity , Administration, Topical , Animals , Antifungal Agents/blood , Boron Compounds/blood , Bridged Bicyclo Compounds, Heterocyclic/blood , Carcinogenicity Tests , Dose-Response Relationship, Drug , Female , Male , Mice , Onychomycosis/drug therapy , Rats , Rats, Sprague-Dawley , Skin Neoplasms/chemically induced , Skin Neoplasms/pathology , Survival Analysis , Weight Gain/drug effects
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