Pelthos Therapeutics Inc. PTHS on Thursday announced the launch of Zelsuvmi (berdazimer) topical gel 10.3% for molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older.
Zelsuvmi received a Novel Drug designation from the U.S. Food and Drug Administration in January 2024 and is the first and only prescription therapy approved for use at home by patients, and caregivers to treat molluscum infections.
Molluscum contagiosum is a highly contagious viral skin condition that afflicts an estimated 16.7 million people, most of them children, with up to 6 million new incidents per year in the United States, the company said.
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Zelsuvmi is a topical nitric oxide-releasing gel for molluscum at diagnosis. The once-daily prescription medication is effective, well-tolerated, and convenient for at-home or on-the-go application.
It can be used to treat infections on the body, including sensitive areas such as the face, groin, or underarms.
Zelsuvmi was studied in the largest randomized clinical trial for the treatment of molluscum.
In the 891-patient phase 3 study:
- Nearly 33% of patients saw complete clearance of molluscum lesions, compared with 19.7% of patients who did not receive the active ingredient at the twelfth week.
- For many patients, Zelsuvmi demonstrated results within two weeks.
“We are launching our ZelsuvmiGo patient support program, which we expect to help onboard patients seamlessly and provide resources for caregivers,” said Sai Rangarao, Chief Commercial Officer at Pelthos.
“To ensure that Zelsuvmi reaches the people who need it quickly, we have hired 50 sales territory managers across the country to work with physicians who treat a high volume of patients with molluscum.”
In April, Ligand Pharmaceuticals Incorporated LGND and Channel Therapeutics Corporation CHRO agreed to combine Ligand’s wholly owned subsidiaries, Pelthos Therapeutics Inc. and LNHC, Inc. (collectively Pelthos), with CHRO Merger Sub Inc., a wholly owned subsidiary of Channel.
The merger was supported by $50 million in capital raised from a group of strategic investors led by Murchinson.
Under the merger agreement, Channel acquired 100% of Pelthos’ issued and outstanding equity interests, changed its name to Pelthos Therapeutics, and started trading on the NYSE American exchange under the ticker PTHS.
Price Action: PTHS stock traded higher by 7.65% to $17.74 premarket at last check Thursday.
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