Watch as Dr James Q Del Rosso discusses the clinical significance of berdazimer topical gel, 10.3%, for molluscum contagiosum, including application details, efficacy, and safety

Ligand Pharmaceuticals Incorporated has achieved a groundbreaking milestone with the recent approval of ZELSUVMI™ (berdazimer topical gel, 10.3%) by the US Food and Drug Administration (FDA). This marks a significant advancement in the treatment of molluscum contagiosum in adult and pediatric patients aged one year and older. 

A novel approach to molluscum treatment

ZELSUVMI is the first and only topical prescription medication that can be applied by patients, parents, or caregivers outside of a medical setting for the treatment of molluscum contagiosum. 

Together with the July 2023 approval of YCANTH (cantharidin topical solution 0.7%), ZELSUVMI has significantly expanded the therapeutic options available for molluscum. 

ZELSUVMI is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties, but the mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown. 

Clinical trial insights

FDA appproval is supported by results from the 12-week pivotal Phase 3 trial B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of molluscum lesions compared with 19.7% of those in the vehicle group (P < .001). 

Safety profile

Common adverse reactions reported included application site reactions such as burning or stinging sensations (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). 

Only 4.1% of patients on berdazimer gel 10.3% and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. 

Future outlook

ZELSUVMI is anticipated to be available in the United States in the second half of 2024, bringing a new level of convenience and effectiveness to the treatment of molluscum contagiosum. This FDA approval marks a significant stride forward in the treatment of molluscum, offering patients and caregivers a user-friendly alternative for managing this condition.