What is the drug Zelsuvmi used for?

October 7, 2025 •

3 min read

Molluscum contagiosum, a highly contagious viral skin condition, affects an estimated 16.7 million people in the United States annually, with a significant number being children. Zelsuvmi (berdazimer) is the first and only FDA-approved at-home topical prescription gel used to treat the lesions caused by this viral infection in adults and pediatric patients aged one year and older.

Quick Summary

Zelsuvmi (berdazimer) is an FDA-approved topical gel for the treatment of molluscum contagiosum in adults and children one year and older. It works by releasing nitric oxide to combat the viral infection and promote the clearing of skin lesions. Application is performed at home, once daily, directly onto the bumps.

Key Points

Treats Molluscum Contagiosum: Zelsuvmi is an FDA-approved topical gel specifically for treating the viral skin infection molluscum contagiosum in adults and children aged one year and older.
At-Home Treatment: It is a convenient, once-daily prescription that can be applied by patients or caregivers at home, eliminating the need for frequent office visits.
Uses Nitric Oxide: The active ingredient, berdazimer, is a nitric oxide-releasing agent that works by disrupting the viral replication process.
Demonstrated Efficacy: Clinical trials, including the B-SIMPLE4 study, showed that Zelsuvmi significantly improved lesion clearance compared to placebo within 12 weeks.
Common Side Effects: The most common adverse reactions are application site reactions, such as pain, burning, redness, and itching, which are typically manageable.
Convenient Application: The medication comes in a two-part gel that is mixed just before application using a provided dosing guide.
Low Risk of Scarring: Unlike some in-office procedures like cryotherapy, Zelsuvmi poses a low risk of causing permanent scarring or pigmentation changes.

What is Molluscum Contagiosum?

Molluscum contagiosum (MC) is a common, self-limiting skin infection caused by a poxvirus. It presents as small, raised, flesh-colored, or red bumps (lesions) that can appear anywhere on the body. While the condition is typically harmless and will eventually resolve on its own, it can persist for months or even years, causing discomfort, itchiness, and social stigma.

The virus spreads through direct skin-to-skin contact or by touching contaminated objects, such as towels or toys. It is especially prevalent in children but also affects adults, particularly those with compromised immune systems. Previously, treatment options were limited and often involved painful procedures performed in a clinic, such as cryotherapy (freezing the lesions) or curettage (scraping them off). The FDA approval of Zelsuvmi offers a convenient, at-home alternative for this common viral infection.

The Science Behind Zelsuvmi (Berdazimer)

Zelsuvmi is a topical gel containing the active ingredient berdazimer sodium, a nitric oxide (NO)-releasing agent. This mechanism is thought to disrupt the molluscum contagiosum virus (MCV) by interfering with viral processes. This may include damaging viral DNA and blocking viral proteins, which can prevent the virus from replicating and spreading. By targeting the virus, Zelsuvmi may help clear lesions and prevent further spread.

The At-Home Treatment Process

Zelsuvmi offers a convenient at-home treatment option. The treatment uses a two-part gel system that is mixed and applied daily.

Step-by-Step Application

The Zelsuvmi package includes two tubes of gel (A and B) and a dosing guide. Equal amounts of gel from each tube are squeezed onto the guide and mixed with a fingertip for about 20 seconds to activate the medication. The mixed gel is then applied as a thin layer to each molluscum bump, covering the lesions completely. After application, the gel should dry for 10 minutes. To ensure effectiveness, avoid washing the treated areas, bathing, or swimming for at least one hour after application. Remember to wash your hands thoroughly after applying the gel. This process is typically repeated once daily for up to 12 weeks under the guidance of a healthcare provider.

Efficacy and Clinical Trial Results

Clinical trials, such as the B-SIMPLE4 Phase 3 study, have demonstrated the efficacy and safety of Zelsuvmi. In the B-SIMPLE4 trial, a significant percentage of patients treated with Zelsuvmi achieved complete clearance of their molluscum lesions after 12 weeks, a better result than those who received a placebo gel. Some patients also experienced improvement as early as two weeks into treatment. Zelsuvmi was generally well-tolerated, with application site reactions being the most common side effects.

Comparing Zelsuvmi to Other Molluscum Treatments

Zelsuvmi offers a convenient at-home option compared to traditional in-office treatments for molluscum. Here's a look at how it compares:


Feature	Zelsuvmi (Berdazimer)	Ycanth (Cantharidin)	Cryotherapy / Curettage
Application Method	At-home topical gel, once daily.	In-office topical solution applied by a healthcare provider.	In-office procedure performed by a healthcare professional.
Convenience	Highly convenient for at-home use.	Requires repeated clinic visits.	Requires clinic visits.
Age Approved	1 year and older.	2 years and older.	Varies by practitioner and patient tolerance.
Pain Level	Mild, temporary application site reactions (burning, stinging) are common.	Can cause pain and blistering.	Can be painful and cause scarring.
Potential for Scarring	Low risk of scarring.	May cause blistering, which can lead to scarring.	Potential for scarring or pigmentation changes.

Potential Side Effects

Like any medication, Zelsuvmi may cause side effects, most commonly application site reactions. These reactions are usually mild to moderate and can include pain, burning, stinging, redness, itching, swelling, peeling, or dermatitis. More severe reactions, such as blistering or allergic contact dermatitis, are possible. It's recommended to contact your healthcare provider if you experience persistent pain, itching, or swelling for over 24 hours.

Conclusion

Zelsuvmi represents a significant advancement in treating molluscum contagiosum, providing an effective and convenient at-home treatment option for individuals aged one year and older. Its mechanism of action, involving the release of nitric oxide to target the virus, helps resolve lesions. While generally well-tolerated with mild side effects, proper application as prescribed is crucial for optimal results. Zelsuvmi offers a less invasive alternative to traditional therapies, potentially improving patient outcomes and reducing the need for clinic visits.

Frequently Asked Questions

Zelsuvmi is a topical gel that comes in two separate tubes, A and B. You must mix equal amounts of gel from both tubes onto the provided dosing guide for 20 seconds before applying a thin, even layer directly to each molluscum bump once a day for up to 12 weeks.

While some patients may see improvement within two weeks, clinical trials showed that many patients achieved complete clearance of their lesions after 12 weeks of treatment. It is important to continue the full course of treatment as prescribed.

Yes, Zelsuvmi is approved for use in pediatric patients one year of age and older. It is not known if it is safe or effective for children under one year.

The most common side effects are application site reactions, which can include pain, burning, stinging, redness, itching, and swelling. These are typically mild and localized to the treatment area.

If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at once.

No, Zelsuvmi is a prescription-only medication. It requires a prescription from a healthcare professional.

Compared to some in-office procedures, Zelsuvmi has a low risk of causing scarring. Some patients may experience temporary skin discoloration at the application site.