FDA approves first treatment for Molluscum contagiosum

Molluscum contagiosum is a highly contagious viral skin infection that primarily affects children.

The Food and Drug Administration has approved the first at-home topical therapy berdazimer gel 10.3% for treatment of Molluscum contagiosum.The medication (Zelsuvmi) is for application outside a clinic by patients including adults and children ages 1 year and older. 

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.

“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. “I look forward to having this novel medication to treat my molluscum patients.”

Molluscum is a highly contagious viral skin infection characterized by skin-colored to red lesions with a central, umbilicated viral core.ii Approximately 6 million Americans, primarily children, are infected each year. However, up to 73% of children go untreated.v Treating the lesions is critical to preventing the viral infection from spreading to other people or to other areas of the body. 

“It is nice to see that molluscum contagiosum is finally getting the attention it deserves. For those of us in the primary care field, it is wonderful to have an effective option that can be used at home rather than taking a wait and watch approach,” said Stephen W. Stripling, MD, Pediatrician, Study Investigator and Molluscum Researcher.

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.

“We are proud of the team’s accomplishment, having completed the world’s largest clinical program in molluscum to bring this first-in-class topical medication to FDA approval,” said Todd Davis, CEO of Ligand. “Pediatricians, dermatologists, and caregivers have long-sought a convenient approach to treat this highly contagious skin infection. With ZELSUVMI, patients now have an at-home treatment option available.”

ZELSUVMI is expected to be available in the United States in the second half of 2024. Complete prescribing information is available at www.zelsuvmi.com.

About ZELSUVMI™ (berdazimer topical gel, 10.3%)

ZELSUVMI (berdazimer topical gel, 10.3%) is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adults and pediatric patients one year of age and older.