Pelthos Therapeutics has commercially launched ZELSUVMI (berdazimer) topical gel 10.3%, marking a significant milestone as the first and only FDA-approved prescription medication for molluscum contagiosum that patients, parents, or caregivers can apply at home without requiring healthcare supervision. The launch addresses a critical unmet medical need for millions of Americans affected by this highly contagious viral skin infection.
Novel Treatment Mechanism and Clinical Efficacy
ZELSUVMI is a once-daily nitric oxide-releasing topical treatment developed using the proprietary NITRICIL technology platform, now owned by Ligand Pharmaceuticals. The medication received Novel Drug designation from the FDA in 2024, recognizing its innovative approach to treating molluscum contagiosum in adults and pediatric patients one year of age and older.
The treatment's efficacy was demonstrated in the largest Phase 3 clinical study conducted for molluscum contagiosum to date—a multicenter, randomized, double-blind, parallel-group, vehicle-controlled study with 891 participants enrolled. By the 12-week mark, complete lesion clearance occurred in approximately 33% of patients treated with berdazimer topical gel compared to 19.7% in the control arm (P < .001). Many patients began seeing improvements within just two weeks of starting treatment.
Addressing Significant Disease Burden
Molluscum contagiosum is caused by a poxvirus and represents one of the most common skin infections encountered by dermatologists, pediatric dermatologists, and pediatricians. The condition affects an estimated 16.7 million people in the United States, with up to 6 million new cases occurring annually, predominantly in children. Individuals with compromised immune systems face elevated risk, with the condition impacting approximately 20% of HIV patients.
The infection spreads through contact with infected persons or contaminated objects including towels, toys, furniture, swimming pools, and other surfaces. Molluscum infections present as raised, flesh-colored or red bumps that can appear anywhere on the body, including sensitive areas such as the face, hands, trunk, genitals, back of the knees, and armpits.
Despite its prevalence, up to 73% of children with molluscum go untreated. An estimated 30% of children will have lesions that persist beyond 18 months, and patients may suffer from itching, secondary bacterial infections from scratching, atopic dermatitis, and social stigma from visible lesions.
Clinical Expert Perspectives
"Many parents delay seeking treatment for their children's uncomfortable lesions because current procedural treatments and frequent office visits can be inconvenient, while therapeutic options are limited," said Nanette Silverberg, MD, Chief of Pediatric Dermatology at the Mount Sinai Health System. "Untreated molluscum can spread throughout the child's body but also to other family members. A safe and effective topical gel for molluscum, like ZELSUVMI, which can be applied at home or on the go, would make a significant difference for this young patient population and address a serious, unmet medical need."
Todd Davis, CEO of Ligand, emphasized the significance of the launch: "Molluscum impacts millions of people in the U.S., particularly children. We are thrilled to see that ZELSUVMI is now commercially available as it addresses a significant unmet need for these patients as the first at-home treatment for this highly contagious viral skin condition."
Safety Profile and Availability
The most commonly reported adverse reactions (≥1%) were application site reactions including pain 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%). The treatment is considered well-tolerated and can be applied to various parts of the body, including delicate areas like the underarms, face, and groin.
Commercial Strategy and Patient Support
Pelthos has implemented a comprehensive commercial strategy to ensure broad access to ZELSUVMI. The company has hired 50 sales territory managers across the country to work with physicians treating high volumes of molluscum patients and has launched extensive digital outreach and awareness efforts.
"We are launching our ZelsuvmiGo patient support program, which we expect to help onboard patients seamlessly and provide resources for caregivers," said Sai Rangarao, Chief Commercial Officer at Pelthos. "To ensure that ZELSUVMI reaches the people who need it quickly, we have hired 50 sales territory managers across the country to work with physicians who treat a high volume of patients with molluscum."
ZELSUVMI is now commercially available through retail pharmacies, ASPN pharmacy services, and for at-home delivery through mail-order pharmacies via prescription.
