Zelsuvmi, First At-Home Prescription Gel for Molluscum Contagiosum, Launches in US

Pelthos Therapeutics announced today it has launched berdazimer topical gel, 10.3% (Zelsuvmi),¹ a first-in-class, nitric oxide-releasing gel approved for at-home application in adults and children aged 1 year and older. The launch marks the first time dermatology clinicians can prescribe an FDA-approved topical molluscum treatment that does not require in-office procedures.

Molluscum contagiosum affects an estimated 16.7 million individuals annually in the US, with 6 million new cases each year, primarily in pediatric populations.¹ Until recently, the only FDA-approved treatment option was cantharidin 0.7% (Ycanth; Verrica Pharmaceuticals), an in-office applied solution approved by the FDA in 2023.² The introduction of Zelsuvmi represents a convenient option for patients that can be self-applied once daily by patients themselves, parents, or caregivers at home or on the go.

“We believe that the commercial launch of Zelsuvmi marks a significant advancement for patients with molluscum and their caregivers, who previously lacked an at-home treatment option for this burdensome skin infection,” said Scott Plesha, CEO of Pelthos, in a news release.¹

A Timeline of Development and Regulatory Milestones

August 2022 – Phase 3 Data Published

Clinical data from the B-SIMPLE4 trial (NCT04535531), the largest randomized trial for molluscum to date, was published in JAMA Dermatology.³ The trial enrolled 891 patients in a multicenter, randomized, double-blind, vehicle-controlled format.

Key findings at week 12 included complete lesion clearance in 32.4% of patients using berdazimer vs 19.7% in the vehicle group. Results observed in as early as 2 weeks for some patients, and berdazimer was well-tolerated safety profile with primarily mild local skin reactions.

March 2023 – NDA Acceptance

Zelsuvmi’s path to availability began when the FDA accepted a New Drug Application (NDA) for berdazimer gel, 10.3%, developed using Pelthos’ proprietary Nitricil technology, which ensures controlled nitric oxide release to enhance antiviral and antimicrobial activity.⁴

January 5, 2024 – FDA Approval

Zelsuvmi received FDA approval as a novel drug, being the first-ever molluscum therapy authorized for at-home prescription use in both children and adults aged ≥1 year.⁵

“The approval of [berdazimer gel] Zelsuvmi is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient, or a family member,” said Mark D. Kaufmann, MD, FAAD, clinical professor of dermatology in the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York, New York and past president of the American Academy of Dermatology, in a press release at the time of the approval.⁵

Read more from Dermatology Times.

April 3, 2024 – Pelthos Therapeutics Launched

To bring Zelsuvmi to market, Ligand Pharmaceuticals launched Pelthos Therapeutics, a commercial-stage biopharmaceutical company focused on advancing Nitricil-based dermatologic treatments.⁶ Under CEO Scott Plesha, Pelthos prepared to scale Zelsuvmi through both traditional pharmacy and mail-order channels.

April 17, 2025 – Pelthos and Channel Therapeutics Merge

To accelerate commercial rollout, Pelthos merged with Channel Therapeutics, backed by a $50 million investment from Ligand and strategic partners including Murchinson.⁷ The move created a newly-formed, publicly-traded entity focused on expanding both Zelsuvmi and a pipeline of sodium channel inhibitors for pain disorders.

July 10, 2025 – Commercial Launch

With pharmacy and mail-order distribution infrastructure in place, Zelsuvmi officially becomes available via prescription nationwide in retail pharmacies, ASPN pharmacy services, and home-delivery options.¹

Clinical Implications for Dermatology Providers

Prior to Zelsuvmi’s approval, treatment of molluscum relied primarily on procedural interventions or unregulated compounded therapies.¹ The introduction of berdazimer gel offers a topical, standardized therapy that expands patient care beyond the office.

“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.¹ “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.”

With Zelsuvmi now on the market, Pelthos aims to build further momentum by exploring the Nitricil platform’s potential in other dermatologic indications.

References

1. Pelthos Therapeutics launches Zelsuvmi (berdazimer) topical gel 10.3%, the first and only FDA-approved at-home treatment for molluscum contagiosum. News release. 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. FDA approves first treatment for molluscum contagiosum. News release. US FDA. July 24, 2023. Accessed July 10, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-molluscum-contagiosum
3. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878. doi:10.1001/jamadermatol.2022.2721
4. FDA accepts Novan’s NDA for berdazimer gel, 10.3% for the treatment of molluscum contagiosum with a PDUFA goal date of January 5, 2024. News release. Novan Inc. Published March 7, 2023.
5. US Food and Drug Administration approves ZELSUVMI as a first-in-class medication for the treatment of molluscum contagiosum. News release. Ligand Pharmaceuticals. January 5, 2024. Accessed July 10, 2025. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx
6. Ligand Pharmaceuticals announces launch of Pelthos Therapeutics to accelerate commercialization of ZELSUVMI. News Release. Ligand Pharmaceuticals. April 3, 2024. Accessed July 10, 2025. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/Ligand-Pharmaceuticals-Announces-Launch-of-Pelthos-Therapeutics-to-Accelerate-Commercialization-of-ZELSUVMI/default.aspx
7. Ligand subsidiary Pelthos Therapeutics to combine with Channel Therapeutics. News release. BioSpace. April 17, 2025. Accessed July 10, 2025. https://www.biospace.com/press-releases/ligand-subsidiary-pelthos-therapeutics-to-combine-with-channel-therapeutics