Q&A: Berdazimer Gel and the Case Against 'Watch-and-Wait' for Molluscum

Until 2024, molluscum contagiosum did not have a US Food and Drug Administration (FDA)-approved therapy. This meant physical modalities, such as curettage and cryotherapy, were all they would rely on and many viewed them as poorly suited to the young children who make up such cases.

That year, berdazimer gel, 10.3% became the first at-home topical for those living with molluscum contagiosum. This decision followed the phase 3 B-SIMPLE4 trial, during which berdazimer demonstrated superiority over vehicle gel.¹ The 891-patient analysis, conducted across 55 US clinics among children as young as 6 months, demonstrated 32.4% complete lesion clearance at the 12-week mark with the topical gel versus 19.7% with vehicle (P < .001).¹

The FDA approved berdazimer gel, marketed as Zelsuvmi, in January 2024, making it the first prescription medication patients or caregivers can apply at home rather than in an office setting.² Pediatric viral skin conditions have historically drawn little drug-development investment, so the approval fills a gap Kircik and other dermatologists have flagged for years. Common adverse events noted in the study were deemed as mild, application-site reactions such as erythema, burning, and itch.¹

At LEADderm 2026 in Newport Beach, California, Leon Kircik, MD, clinical professor of dermatology at the Icahn School of Medicine at Mount Sinai and medical director of DermResearch, Physicians Skin Care, and Skin Sciences, in Louisville, Kentucky joined Lisa Swanson, MD, to challenge the watch-and-wait approach to molluscum and review berdazimer's role in practice. In the following Q&A interview, Kircik spoke with HCPLive at the meeting about the rationale behind the session and where he sees treatment options heading next:

HCPLive: Why was your LEADderm talk with Dr. Swanson on challenging watch-and-wait for molluscum important for attending clinicians?

Leon Kircik, MD: Molluscum is a big challenge in our treatment armamentarium. Until recently, we did not have any FDA-approved treatments, unfortunately. Mostly molluscum affects little children, and that means you have to deal with their parents, which becomes another challenge. It's a virus, a smallpox virus, so people get concerned, and sometimes pediatricians tell parents it's okay, it's going to go away. Yeah, probably, but it can take more than a year. It's a very challenging diagnosis to deal with and treat, even though it looks simple. I think we're very lucky that we now have berdazimer, an FDA-approved treatment that can be done at home. You do not have to curette the kids or freeze the lesions, so you don't have to make them cry and deal with upset parents. It's a really difficult thing to deal with in our offices every day.

HCPLive: What does the current treatment paradigm for molluscum look like, and how far do we still have to go?

Leon Kircik, MD: The challenge is it's a virus, and we do not have a cure for viruses, only treatment options. Until recently, as I mentioned, we did not even have an FDA-approved treatment. All we had were off-label options, like topical retinoids approved for acne or topical antivirals approved for genital warts, or physical modalities. The physical modalities are challenging to use on 2- or 3-year-old kids.

You have to curette, and someone has to hold the child while a parent watches, or if you freeze the lesions, that's difficult too. I sometimes apply trichloroacetic acid or liquid nitrogen with a Q-tip so they don't cry, but it's still difficult. Any physical modality on a pediatric population is hard to manage. At-home treatments were limited, and we still don't have much except berdazimer, now an approved treatment. It's challenging, and hopefully we will have more options soon.

HCPLive: What do you hope berdazimer gel improves, and what has your clinical experience with it been so far?

Leon Kircik, MD: Unfortunately, the pediatric population doesn't get much attention in drug development, and this is one of those areas. Look at warts. We still don't have an FDA-approved treatment for warts at this day and age. Antiviral treatments are not a cure; they're just a treatment option. Nothing eliminates the virus permanently, so it's a real treatment challenge with cutaneous viral diseases like molluscum and warts.

HCPLive: What were the biggest takeaways from the session clinicians should know?

Leon Kircik, MD: Everybody was welcoming and very interested. The meeting gave us a chance, right before the scientific sessions, to talk about something that grounded us in our profession, which was lovely and different from other meetings. That's what I call the salt and pepper on the scientific session.

HCPLive: Where do you hope molluscum treatment goes next, and are promising options on the horizon?

Leon Kircik, MD: I do a lot of clinical studies, so I closely follow what's going on in development. There are other options being studied and considered, so hopefully we will have more options in our armamentarium for treating molluscum in the coming years.

HCPLive: Beyond molluscum, what development in dermatology right now are you most excited about?

Leon Kircik, MD: I'm really excited about the development in treatment options for alopecia areata. This was a forgotten area for a long time, and we didn't have much. Now we have 3 JAK inhibitors approved for alopecia areata, and we're looking forward to many other options. A biologic option would be especially welcome because it would be something we can use long-term, both efficaciously and safely.

Editor’s note: Kircik has disclosed receiving research funding, honoraria, and speaking fees from Novan, Inc., and its successor, Pelthos Therapeutics, maker of berdazimer. This transcript has been edited for grammar and clarity using artificial intelligence tools.

References

1. 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.

2. US Food and Drug Administration approves ZELSUVMI as a first-in-class medication for the treatment of molluscum contagiosum. Ligand Pharmaceuticals. Press release. Published January 5, 2024. Accessed September 16, 2026. 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.