FDA Approves ZELSUVMI™ as a First-in-Class Medication for Molluscum Contagiosum

ZELSUVMI™ is expected to be commercially available during the second half of 2024.

Ligand Pharmaceuticals Incorporatedtoday announced that the US 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.¹ 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. 

“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.”

Stephen W. Stripling, MD, pediatrician, study investigator and molluscum researcher, added in a press release: “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."

ZELSUVMI is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties.² 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.³ The B-SIMPLE Phase 3 program enrolled 1,598 patients.⁴ 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.

References

1. ZELSUVMI Package Insert. LNHC Inc. 2023.
2.  Ward BM, Riccio DA, Cartwright M, Maeda-Chubachi T. Anitviral effect of berdazimer sodium on molluscum contagiosum virus using a novel in vitro methodology. Viruses. 2023;15(12):2360. doi:10.3390/v15122360
3. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide−releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878
4. Sugarman JL, Hebert A, Browning JC, et al. Berdazimer gel for molluscum contagiosum: an integrated analysis of 3 randomized controlled trials. J Am Acad Dermatol. 2023;doi:10.1016/j.jaad.2023.09.066