STEPS
New Drug Reviews

Berdazimer (Zelsuvmi) for the Treatment of Molluscum Contagiosum

William Dabbs, MD, FAAFP
Shauntá Chamberlin, PharmD

American Family Physician. 2025;111(3):263-264.

Author disclosure: No relevant financial relationships.

DrugDosageDose formCost*
Berdazimer (Zelsuvmi)Apply once daily for up to 12 weeksTopical gel$700

*—Estimated retail price of one carton, including one tube of berdazimer gel and one tube of hydrogel. Actual cost will vary with insurance and by region. Information obtained at https://www.drugpatentwatch.com (accessed January 13, 2025; zip code: 66211).

Berdazimer (Zelsuvmi) is a topical, nitric oxide–releasing agent that is theorized to treat molluscum contagiosum through antiviral and immunomodulatory properties.1 It is labeled for use in adults and children older than 1 year.2 Berdazimer consists of two components: the active ingredient, berdazimer sodium, binds nitric oxide, and a hydrogel acts as a proton donor. Combining these two components before application forms the therapeutic agent that releases nitric oxide from the berdazimer sodium polymer in a controlled, localized, topical application.1

SAFETY

Berdazimer is a generally safe medication, although allergic contact dermatitis may occur. There have been no other major adverse effects reported in adults or children older than 1 year. No data are available to support its safe use in pregnant or breastfeeding patients; however, it is considered safe to use during breastfeeding as long as infant contact with treated skin is avoided, and it is not applied to the nipple area.3,4

TOLERABILITY

The most common adverse effect is application site reaction. Pain, erythema, and pruritus are the most prevalent symptoms when these reactions occur. Adverse effects are typically mild or moderate and rarely severe.3 Discontinuation rates with normal use are less than 3% in studied populations, which are similar to placebo.1

EFFECTIVENESS

Berdazimer reduces the number of molluscum contagiosum lesions and can lead to complete clearance in some patients. In a phase 3 randomized controlled trial of 891 adults and children that compared berdazimer treatment with the hydrogel vehicle, 32.7% of patients taking berdazimer had complete clearance at 12 weeks (12.7% absolute risk increase; adjusted odds ratio = 2.0; 95% CI, 1.5–2.8; number needed to treat [NNT] = 8).5 A meta-analysis including this trial and two other studies found significantly higher rates of complete clearance in the berdazimer group at 8 and 12 weeks, with risk ratios of 1.73 and 1.54, respectively.6 The estimated absolute risk increase in the rate of complete clearance with berdazimer at 12 weeks in the meta-analysis was 10.8% (NNT = 9). Berdazimer has not been compared with cryotherapy, curettage, cantharidin (Ycanth), and imiquimod regarding effectiveness or patient satisfaction.

PRICE

Berdazimer costs approximately $700 for one carton, which includes one tube of berdazimer gel and one tube of hydrogel.

SIMPLICITY

Berdazimer may be difficult for patients to prepare and apply. The two components must be mixed using the provided dosing card and then applied to each lesion. Berdazimer must be applied immediately after preparation, which requires patients to prepare berdazimer daily before each application for up to 12 weeks. The treatment must dry for 10 minutes after application, and patients should avoid getting the area wet (eg, bathing, washing, swimming) for 1 hour.3

WILLIAM DABBS, MD, FAAFP, and SHAUNTA’ CHAM-BERLIN, PharmD, University of Tennessee Graduate School of Medicine, Knoxville.

Address correspondence to William Dabbs, MD, FAAFP, at wdabbs@utmck.edu.

Author disclosure: No relevant financial relationships.

  1. 1.Cartwright M, Enloe C, Stripling S, et al. Pharmacokinetic profile, safety, and tolerability of topical berdazimer gel, 10.3% in patients with molluscum contagiosum. J Drugs Dermatol. 2022;21(10):1104-1110.
  2. 2.Keam SJ. Berdazimer topical gel, 10.3%: first approval. Drugs. 2024;84(3):363-368.
  3. 3.Zelsuvmi (berdazimer) topical gel. Highlights of prescribing information. Accessed May 3, 2024. https://zelsuvmi.com/wp-content/uploads/2024/01/ZELSUVMI-Berdazimer-Topical-Gel-10.3.-Prescribing-Information-and-Instructions-for-Use.pdf
  4. 4.National Library of Medicine. Drugs and lactation database (LactMed). National Institute of Child Health and Human Development; 2006-. Berdazimer. Updated August 15, 2024. Accessed January 29, 2025. https://www.ncbi.nlm.nih.gov/books/NBK606324/
  5. 5.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.
  6. 6.Pera Calvi I, Marques IR, Cruz SA, et al. Safety and efficacy of topical nitric oxide–releasing berdazimer gel for molluscum contagiosum clearance: a systematic review and meta-analysis of randomized controlled trials. Pediatr Dermatol. 2023;40(6):1060-1063.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

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