Given the limited data available from clinical trials, it is not easy to make an early, accurate assessment of a new drug. Ketoconazole, initially known by its development number, R 41400, is no exception. At this point, ketoconazole seems to be a highly efficacious, broadspectrum, oral antifungal agent that may be the most important drug of its class ever developed.
A new drug application for ketoconazole was filed with the Food and Drug Administration in July 1980. The FDA assigned ketoconazole a 1-A rating, which signifies a new compound of special therapeutic merit deserving "fast track" review by that agency. In June 1981, ketoconazole was approved by the FDA as indicated for the treatment of candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, coccidioidomycosis, histoplasmosis, chromoblastomycosis, and paracoccidioidomycosis.
The in vivo mechanism of action of ketoconazole is fairly well understood.1 Ergosterol, the major fungal sterol critical to membrane integrity, must
Jones HE. Ketoconazole. Arch Dermatol. 1982;118(4):217-219. doi:10.1001/archderm.1982.01650160007009