Core Insights - Pelthos Therapeutics Inc. has launched ZELSUVMI™ (berdazimer) topical gel, a novel treatment for molluscum contagiosum, which is the first prescription therapy approved for at-home use by patients and caregivers [1][7][10] - The product received Novel Drug designation from the U.S. FDA in January 2024 and is aimed at addressing a significant unmet medical need for patients suffering from this highly contagious viral skin condition [1][7][10] Company Overview - Pelthos Therapeutics is a biopharmaceutical company focused on commercializing innovative therapeutic products to meet high unmet patient needs [10] - The company’s lead product, ZELSUVMI, was approved by the U.S. FDA in 2024 and is designed to be safe and effective for treating molluscum contagiosum [10] Product Details - ZELSUVMI is a once-daily topical gel that releases nitric oxide, indicated for the treatment of molluscum contagiosum in patients aged one year and older [7][10] - The product was validated through a Phase 3 clinical trial involving 891 patients, showing nearly 33% complete clearance of lesions at week twelve compared to 19.7% in the control group [2][7] Market Need - Molluscum contagiosum affects an estimated 16.7 million people in the U.S., with up to 6 million new cases annually, primarily among children [4][5] - Many parents delay treatment due to the inconvenience of current procedural options, highlighting the need for an effective at-home treatment like ZELSUVMI [3][4] Commercial Strategy - Pelthos has initiated the ZelsuvmiGo patient support program to facilitate patient onboarding and provide resources for caregivers [3] - The company has hired 50 sales territory managers to promote ZELSUVMI to physicians treating high volumes of molluscum patients and has implemented extensive digital outreach efforts [3][5]