Berdazimer Topical Gel 10.3% Launched as Treatment for Molluscum Contagiosum

Berdazimer (ZELSUVMI) topical gel, 10.3% has been commercially launched as an available treatment for molluscum contagiosum, specifically indicated for adults and children aged 1 year and older.1,2

The July 10 announcement was released by Pelthos Therapeutics Inc., a biopharmaceutical company. Berdazimer topical gel, 10.3% was granted Novel Drug designation by the US Food and Drug Administration (FDA), which marked it as the first and only prescription therapy for molluscum that patients, parents, or caregivers can apply at home without the need for in-office healthcare supervision.

"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,” Nanette Silverberg, MD, Chief of Pediatric Dermatology at the Mount Sinai Health System, said in a statement.1 “Untreated molluscum can spread throughout the child’s body but also to other family members. A safe and effective topical gel for molluscum, like [berdazimer topical gel], 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.”

Molluscum contagiosum is known to be both a common and highly transmissible viral skin infection. The condition is caused by a poxvirus and it is believed to affect an estimated 16.7 million individuals within the US. Up to 6 million new cases are reported annually, and these are primarily cases among children. The skin infection disproportionately impacts immunocompromised individuals, and this includes approximately 20% of those living with HIV. Despite molluscum contagiosum's prevalence, as many as 73% of molluscum cases in children are believed to go untreated.

Berdazimer topical gel is a once-daily, nitric oxide-releasing topical treatment developed with the proprietary NITRICIL technology platform, now owned by Ligand Pharmaceuticals, Inc.2 The treatment is considered to be a convenient and well-tolerated option. It can be implemented on various parts of the body, including delicate areas like the underarms, face, and groin.

Berdazimer was assessed in the largest phase 3 clinical study conducted for molluscum contagiosum to date—a multicenter, randomized, double-blind, parallel-group, vehicle-controlled study that reported having 891 participants enrolled.1 By the 12-week mark, investigators found that complete lesion clearance had taken place in approximately 33% of trial subjects treated with berdazimer topical gel. This was compared to 19.7% in the control arm of the study (P < .001). Many patients began seeing improvements within just two weeks of starting treatment.

The investigators also highlighted the most commonly observed adverse events (≥1%). They noted that these were application site reactions including pain such as erythema (11.7%), stinging or burning sensations (18.7%), itch (5.7%), dermatitis (4.9%), exfoliation (5.0%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), irritation (1.2%), vesicles (1.5%), and infection (1.1%).

“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,” Todd Davis, CEO of Ligand, said in a statement.2 “This milestone payment highlights the ongoing progress and significant value of our partnered programs as well as the strength of our business model, which is built on innovation, strategic collaboration, and long-term value creation for our shareholders.”

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, Inc. July 10, 2025. https://www.globenewswire.com/news-release/2025/07/10/3113206/0/en/Pelthos-Therapeutics-Launches-ZELSUVMI-berdazimer-Topical-Gel-10-3-the-First-and-Only-FDA-Approved-At-Home-Treatment-for-Molluscum-Contagiosum.html.

2. Ligand Partner Pelthos Therapeutics Launches ZELSUVMI™. Ligand Therapeutics. July 10, 2025. https://investor.ligand.com/news-and-events/press-releases/news-details/2025/Ligand-Partner-Pelthos-Therapeutics-Launches-ZELSUVMI/default.aspx.