The U.S. Food and Drug Administration (FDA) approved Zelsuvmi^™ (berdazimer topical gel, 10.3%), on Jan. 5, 2024. The first of its kind, the gel produces an antiviral agent, nitric oxide, to treat molluscum contagiosum, a skin infection that affects as many as 6 million individuals in the U.S. annually. Zelsuvmi is dispensed in two separate tubes. Immediately before use, approximately 0.5mL of gel from each tube is mixed on a dosing guide that is included with each prescription. For treating patients as young as one year old, it is applied to each sore once every day for up to three months. Patients or their caregivers can apply Zelsuvmi at home; it does not have to be given by a health professional. The manufacturer, Ligand Pharmaceuticals, plans to introduce Zelsuvmi to the U.S. market in the second half of 2024, but it has not disclosed the wholesale acquisition cost (WAC). Complete prescribing information is here.

At a Glance

• Brand (Generic) Name: Zelsuvmi (berdazimer topical gel, 10.3%)
• Manufacturer: Ligand Pharmaceuticals
• Date Approved: Jan. 5, 2024
• Indication: for topical treatment of molluscum contagiosum in patients one year of age and older
• Dosage Forms Available: boxes of two tubes – tube A (blue label and cap) containing 17gm of berdazimer gel and tube B (yellow label and cap) containing 17gm of hydrogel
• Launch Date: second half of 2024
• Estimated Annual Cost: Not yet available
• Molluscum contagiosum is a skin disease caused by a virus. It produces small, inflamed, and/or itchy bumps similar to chicken pox, which spread easily to other parts of the patient’s body and to other people. Without treatment, molluscum contagiosum bumps can last for years.
• It is estimated to affect about six million Americans, mostly children.
• Zelsuvmi generates nitric oxide, a known antiviral agent.
• In two phase III clinical studies, nearly 1,600 patients used Zelsuvmi or a placebo gel once a day for three months. Molluscum contagiosum resolved completely for about 10% more of those using Zelsuvmi than for participants using inactive gel base (30% vs 20%).
• The most commonly reported side effects were application site pain, redness, and itching.
• Molluscum contagiosum also may be treated with oral cimetidine, topical products that include podophyllotoxin or salicylic acid, or physical removal of bumps with a scalpel, a laser, or liquid nitrogen.
• In July 2023, the FDA approved Ycanth^™ (cantharidin) topical solution, 0.7%, as the first prescription drug specifically indicated to treat molluscum contagiosum. It is indicated only for patients who are two years old and older and it must be applied in a health facility by a specially trained healthcare provider. The recommended dose is one drop per sore once every three weeks for as long as needed.