Pelthos Therapeutics Inc. has officially launched ZELSUVMI™ (berdazimer) topical gel, 10.3%, an important breakthrough as the first and only FDA-approved at-home prescription treatment for molluscum contagiosum. This once-daily topical gel is indicated for both adults and pediatric patients as young as one year old, addressing a significant unmet medical need for a highly contagious viral skin condition that affects an estimated 16.7 million people annually in the U.S., with a large proportion being children.

Before ZELSUVMI, treatment options for molluscum were often limited to in-office procedures, which could be inconvenient, uncomfortable for children, and a deterrent for many parents seeking care. The novel drug designation from the U.S. Food and Drug Administration in January 2024 underscores its innovative nature. ZELSUVMI's key advantage lies in its convenience: it can be applied by patients, parents, or caregivers directly at home or on the go, eliminating the need for frequent physician visits. This flexibility is particularly beneficial given the widespread nature of molluscum and its potential for lesions to persist for months to years if untreated.

Clinical trials, including the largest randomized study for molluscum treatment involving 891 patients, demonstrated ZELSUVMI's efficacy and safety. Nearly 33% of patients achieved complete clearance of molluscum lesions by the twelfth week, with many showing results within just two weeks. As a nitric oxide-releasing gel, it works to clear the lesions effectively and is well-tolerated, even for sensitive areas like the face, groin, or underarms.

To ensure broad access, Pelthos Therapeutics is making ZELSUVMI commercially available through various channels, including retail pharmacies, ASPN pharmacy services, and mail-order pharmacies. The company is also supporting its launch with a ZelsuvmiGo patient support program to assist with onboarding and provide resources for caregivers. Furthermore, a dedicated sales team of 50 territory managers and extensive digital outreach efforts aim to ensure that healthcare providers can easily prescribe ZELSUVMI to those who need it most. This comprehensive approach by Pelthos reflects a strong commitment to improving the quality of life for individuals, especially children, impacted by molluscum contagiosum.