FDA-approved berdazimer gel, 10.3% launches to treat molluscum contagiosum

FDA-approved berdazimer gel, 10.3% launches to treat molluscum contagiosum | Image Credit: © syahrir - ©syahrir - stock.adobe.com.

Pelthos Therapeutics has launched berdazimer (Zelsuvmi) topical gel, 10.3%, for the treatment of molluscum contagiosum in adults and pediatric patients aged 1 year and older, according to a company announcement on July 10, 2025. The nitric oxide–releasing topical is the first prescription medication approved for at-home treatment of molluscum contagiosum, a common viral skin infection.¹

The July launch follows the FDA’s January 5, 2024, approval of berdazimer topical gel, 10.3%, for use in this patient population. In the phase 3 B-SIMPLE4 trial, berdazimer demonstrated a statistically significant improvement in lesion clearance compared to vehicle, with 32.4% of patients achieving complete clearance of molluscum lesions at 12 weeks versus 19.7% of those treated with vehicle (P < .001). The trial enrolled 891 patients aged 6 months and older with 3 to 709 raised molluscum contagiosum lesions and evaluated once-daily application over 12 weeks.²

Berdazimer topical gel, 10.3%, is now available through retail pharmacies, ASPN pharmacy services, and mail-order pharmacies.1 Pelthos has launched the ZelsuvmiGo patient support program to help facilitate access and provide education for patients and caregivers.¹

“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. Untreated molluscum can spread throughout the child’s body but also to other family members,” said Nanette Silverberg, MD, chief of Pediatric Dermatology at the Mount Sinai Health System in a press release. “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.”¹

The launch marks the first topical nitric oxide–releasing therapy for molluscum contagiosum that patients, parents, or caregivers can administer at home, offering an alternative to in-office procedures. Previously, treatment options primarily included lesion destruction or observation, leaving a gap for those unable to access office-based care.²

Molluscum contagiosum is a highly contagious poxvirus infection, estimated to affect up to 16.7 million people in the United States, with approximately 6 million new cases each year. Most cases occur in children, and lesions can last for months to years if untreated. Patients may experience complications such as itching, secondary bacterial infections, or atopic dermatitis.1 Up to 73% of children with molluscum go untreated.¹

Berdazimer topical gel, 10.3%, was granted novel drug designation by the FDA in 2024. The product’s nitric oxide–releasing mechanism, developed using the proprietary NITRICIL platform, acts directly on molluscum lesions. Common adverse events include application site reactions such as burning, erythema, and pruritus.

The once-daily gel is approved for use on various body areas, including the face, groin, and underarms. In clinical trials, some patients saw results as early as 2 weeks, though the primary endpoint was measured at week 12.

"The fact that it can be applied at home will also open the doors to treatment for families who are unable to come to the office for their treatments, which are traditionally administered by a provider and often require multiple sessions for complete clearance," said Smita Aggarwal, MD, at the time of FDA approval. "Now, more patients will be able to treat their molluscum early before lesions have a chance to spread and cause further complications," Aggarwal added.²

References:

1. Pelthos Therapeutics Launches ZELSUVMI™ (berdazimer) Topical Gel 10.3%, the First and Only FDA-Approved At-Home Treatment for Molluscum Contagiosum. Pelthos Therapeutics. July 10, 2025. Accessed July 10, 2025. https://pelthos.com/pelthos-therapeutics-launches-zelsuvmi-berdazimer-topical-gel-10-3-the-first-and-only-fda-approved-at-home-treatment-for-molluscum-contagiosum/
2. Fitch J. FDA approves prescription berdazimer gel, 10.3% to treat molluscum contagiosum. Contemporary Pediatrics. January 5, 2024. Accessed July 10, 2025. https://pelthos.com/pelthos-therapeutics-launches-zelsuvmi-berdazimer-topical-gel-10-3-the-first-and-only-fda-approved-at-home-treatment-for-molluscum-contagiosum/