Sato Pharmaceutical obtained marketing and manufacturing approval for NAILIN® Capsules 100mg as an oral treatment for onychomycosis.

This product is the first new treatment for the disease in approximately 20 years. NAILIN® Capsules 100mg contains the active ingredient fosravuconazole L-lysine ethanolate which was discovered by Eisai and has improved bioavailability compared to ravuconazole.

Caused by the invasion of the nails by the Trichophyton fungus via the skin of the hands and feet, onychomycosis is a fungal infection that induces symptoms such as the clouding and thickening of nails as well as hyperkeratosis in the area surrounding the nail. Onychomycosis affects 1 in every 10 Japanese people with an estimated approximately 11 million sufferers in Japan, and incidence rises with age.

In Phase III clinical study conducted by Sato Pharmaceutical of NAILIN® Capsules 100mg administered orally once daily for 12 weeks in patients with onychomycosis conducted in Japan, superior efficacy was confirmed for NAILIN® Capsules 100mg compared to placebo.

Going forward, Sato Pharmaceutical will conduct marketing of NAILIN® Capsules 100mg, while Sato Pharmaceutical and Eisai are jointly providing information on its proper use. By expanding the options for treating onychomycosis through NAILIN® Capsules 100mg, the two companies are striving to further contribute to the treatment of onychomycosis patients.