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Pelthos Therapeutics (NYSE American: PTHS) has launched ZELSUVMI™ (berdazimer) topical gel 10.3%, marking a significant milestone as the first and only FDA-approved at-home treatment for molluscum contagiosum. The novel nitric oxide-releasing gel, which received FDA Novel Drug designation in January 2024, is now commercially available through prescription.
In Phase 3 clinical trials involving 891 patients, ZELSUVMI demonstrated complete clearance in 33% of patients compared to 19.7% in the control group at week 12, with some patients showing results within two weeks. The treatment targets an estimated 16.7 million affected people in the United States, with up to 6 million new cases annually.
To support the launch, Pelthos has deployed 50 sales territory managers nationwide and implemented the ZelsuvmiGo patient support program to facilitate patient access and education.
Pelthos Therapeutics (NYSE:PTHS) has completed its merger with Channel Therapeutics and secured a $50.1 million private placement. The combined company will begin trading on the NYSE American exchange under the ticker PTHS on July 2, 2025.
The private placement, led by Murchinson Ltd., includes the cancellation of $18.8 million in bridge capital. Pelthos will focus on launching ZELSUVMI™, an FDA-designated novel drug for molluscum contagiosum infections, which affects approximately 16.7 million people in the United States. The medication is the first prescription treatment that can be administered at home.
The company will also evaluate NaV 1.7 development programs for various pain treatments. Scott Plesha will serve as CEO, while former Channel Therapeutics CEO Frank Knuettel II becomes CFO of the combined entity.
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