The U.S. Food and Drug Administration (FDA) has approved ZELSUVMI™ (berdazimer topical gel, 10.3%) from Ligand Pharmaceuticals Incorporated for the treatment of molluscum contagiosum in adults and pediatric patients aged one year and above.
It is the second FDA-approved treatment for molluscum contagiosum following the approval of VP-102 (YCANTH™) in July 2023.
ZELSUVMI however, is the first and only topical prescription medication that can be applied by the patient or their parents or caregivers at home, outside of a physician’s office or medical setting.
The approval of ZELSUVMI, a nitric oxide-releasing agent, was based on positive data from the B-SIMPLE 4 Phase 3 trial, which showed statistically significant improvements in the clearance of treatable molluscum contagiosum at week 12. The most commonly reported adverse reactions were application site reactions, erythema, pruritus, exfoliation, and dermatitis.
“The approval of ZELSUVMI is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient, or a family member,” said Mark D. Kaufmann, MD, FAAD, a Clinical Professor of Dermatology in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City and Past President of the American Academy of Dermatology.