Berdazimer sodium, sold under the brand name Zelsuvmi, is a medication used for the treatment for molluscum contagiosum.[1] Berdazimer sodium is a nitric oxide releasing agent.[1] It is a polymer formed from sodium 1-hydroxy-3-methyl-3-(3-(trimethoxysilyl)propyl)-1-triazene-2-oxide and tetraethyl silicate.[3]
 | |
| Clinical data | |
|---|---|
| Trade names | Zelsuvmi |
| Other names | SB206 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624007 |
| License data | |
| Routes of administration | Topical |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | Indeterminate[1] |
| Molar mass | Indeterminate[1] |
The most common side effects occurred at the drug application site including pain, rash, itch, eczema, swelling, erosion, discoloration, blister, irritation, and infection.[2] Other common side effects included fever, vomiting, and upper respiratory infections (common cold).[2]
Berdazimer sodium was approved for medical use in the United States in January 2024.[4][5][6]
Medical uses
editBerdazimer sodium is indicated for the topical treatment of molluscum contagiosum.[1]
Pharmacology
editMechanism of action
editBerdazimer sodium is a nitric oxide releasing agent.[1] The mechanism of action for the treatment of molluscum contagiosum is unknown.[1]
History
editThe 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.[2] The trials were conducted at 121 sites in the United States.[2] Among the 1,598 enrolled participants, all of them were evaluated for efficacy and 1,596 were evaluated for safety.[2] 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.[2] Efficacy was assessed as the proportion of participants achieving complete clearance at week twelve.[2] Complete clearance was defined as the subject having a total of molluscum contagiosum lesion count of zero at assessment.[2] Trial 1 enrolled 891 participants, trial 2 enrolled 355 participants, and trial 3 enrolled 352 participants.[1] 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.[1]
Society and culture
editLegal status
editBerdazimer sodium was approved for medical use in the United States in January 2024.[2][5]
Names
editBerdazimer sodium is the international nonproprietary name.[7]
Berdazimer sodium is sold under the brand name Zelsuvmi.[1]
References
edit- ^ a b c d e f g h i j k "Zelsuvmi (berdazimer) topical gel" (PDF). Archived (PDF) from the original on 19 January 2024. Retrieved 9 January 2024.
- ^ a b c d e f g h i j "Drug Trials Snapshots: Zelsuvmi". U.S. Food and Drug Administration (FDA). 5 January 2024. Archived from the original on 29 August 2024. Retrieved 2 September 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "Berdazimer sodium". GSRS. Archived from the original on 8 January 2024. Retrieved 8 January 2024.
- ^ "Drug Approval Package: Zelsuvmi". U.S. Food and Drug Administration (FDA). 2 February 2024. Archived from the original on 11 March 2024. Retrieved 11 March 2024.
- ^ a b "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- ^ "U.S. Food and Drug Administration Approves Zelsuvmi as a First-in-Class Medication for the Treatment of Molluscum Contagiosum". Ligand Pharmaceuticals. 5 January 2024. Archived from the original on 8 January 2024. Retrieved 8 January 2024 – via Business Wire.
- ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
Further reading
edit- 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
edit- "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
