Berdazimer sodium

Berdazimer sodium, sold under the brand name Zelsuvmi, is a medication used for the treatment for molluscum contagiosum. Berdazimer sodium is a nitric oxide releasing agent. It is a polymer formed from sodium 1-hydroxy-3-methyl-3-(3-(trimethoxysilyl)propyl)-1-triazene-2-oxide and tetraethyl silicate.

The most common side effects occurred at the drug application site including pain, rash, itch, eczema, swelling, erosion, discoloration, blister, irritation, and infection. Other common side effects included fever, vomiting, and upper respiratory infections (common cold).

Berdazimer sodium was approved for medical use in the United States in January 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

Medical uses

Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum.

Pharmacology

Mechanism of action

Berdazimer sodium is a nitric oxide releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.

History

The US Food and Drug Administration (FDA) approved berdazimer sodium based on evidence from three clinical trials (NI-MC301, NI-MC302, and NI-MC304) of 1,598 participants with molluscum contagiosum. The trials were conducted at 121 sites in the United States. Among the 1,598 enrolled participants, all of them were evaluated for efficacy and 1,596 were evaluated for safety. In all three trials, participants with molluscum contagiosum were randomized to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks. Efficacy was assessed as the proportion of participants achieving complete clearance at week twelve. Complete clearance was defined as the subject having a total of molluscum contagiosum lesion count of zero at assessment. Trial 1 enrolled 891 participants, trial 2 enrolled 355 participants, and trial 3 enrolled 352 participants. Participants were randomized 1:1 in trial 1, and 2:1 in trials 2 and 3 to receive berdazimer sodium or vehicle applied to molluscum contagiosum lesions once daily for up to twelve weeks.

Society and culture

Legal status

Berdazimer sodium was approved for medical use in the United States in January 2024.

Names

Berdazimer sodium is the international nonproprietary name.

Berdazimer sodium is sold under the brand name Zelsuvmi.

Research

Berdazimer sodium is being investigated for acne vulgaris due to nitric oxide's ability to inhibit the NLRP3 inflammasome and C. acnes IL-1β activity, reducing inflammation. A phase 2 study demonstrated a significant reduction in non-inflammatory acne lesions compared to vehicle, but no significant improvement using the investigator global assessment (IGA) scores.

References

Further reading

• Pera Calvi I, R Marques I, Cruz SA, Mesquita YL, Padrao EM, Souza RM, et al. (2023). "Safety and efficacy of topical nitric oxide-releasing berdazimer gel for molluscum contagiosum clearance: A systematic review and meta-analysis of randomized controlled trials". Pediatric Dermatology. 40 (6): 1060–1063. doi:10.1111/pde.15419. PMID 37721050. S2CID 262045499.
• Han H, Smythe C, Yousefian F, Berman B (February 2023). "Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review". Journal of Drugs in Dermatology. 22 (2): 182–189. doi:10.36849/JDD.7230. PMID 36745361. S2CID 256613906.
• Lacarrubba F, Micali G, Trecarichi AC, Quattrocchi E, Monfrecola G, Verzì AE (December 2022). "New Developing Treatments for Molluscum Contagiosum". Dermatology and Therapy. 12 (12): 2669–2678. doi:10.1007/s13555-022-00826-7. PMC 9674806. PMID 36239905.
• Ward BM, Riccio DA, Cartwright M, Maeda-Chubachi T (November 2023). "The Antiviral Effect of Berdazimer Sodium on Molluscum Contagiosum Virus Using a Novel In Vitro Methodology". Viruses. 15 (12): 2360. doi:10.3390/v15122360. PMC 10747301. PMID 38140601.

External links

• "Berdazimer Sodium (Code C174810)". NCI Thesaurus.
• Clinical trial number NCT04535531 for "A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)" at ClinicalTrials.gov
• Clinical trial number NCT03927703 for "A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC (B-SIMPLE2)" at ClinicalTrials.gov
• Clinical trial number NCT03927716 for "A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)" at ClinicalTrials.gov