Ligand Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved ZELSUVMI? (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older.i The FDA approved ZELSUVMI as the first novel drug for the treatment of molluscum infections. ZELSUVMI is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician's office, or other medical setting to treat this highly contagious viral skin infection.

ZELSUVMI is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties.vii The mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown. Nevertheless, ZELSUVMI's efficacy was demonstrated in 2 Phase 3 trials - B-SIMPLE 4 and B-SIMPLE 2. These trials showed ZELSUVMI's ability to reduce lesion counts and was well tolerated when used once a day.viii The B-SIMPLE Phase 3 program enrolled 1,598 patients.ix The most commonly reported adverse reactions (=1%) in clinical trials were application site reactions.

See additional Important Safety Information for ZELSUVMI below. ZELSUVMI is expected to be available in the United States in the second half of 2024.