Chemistry:Berdazimer sodium
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| Clinical data | |
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| Trade names | Zelsuvmi |
| Other names | SB206 |
| License data | |
| Routes of administration | Topical |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
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| Chemical and physical data | |
| Formula | Indeterminate[1] |
| Molar mass | Indeterminate[1] |
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.[2]
Berdazimer sodium was approved for medical use in the United States in January 2024.[3][4]
Medical uses
Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum.[1]
Warnings and Precaustions
Application site reactions, including allergic contact dermatitis, have occurred in patients treated with Zelsuvmi (Berdazimer sodium). Suspect allergic contact dermatitis in the event of pain, pruritus, swelling or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.
Mechanism of Action
Berdazimer sodium is a nitric oxide releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.
Society and culture
Legal status
Berdazimer sodium was approved for medical use in the United States in January 2024.[3]
Names
Berdazimer sodium is the international nonproprietary name.[5]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Zelsuvmi (berdazimer) topical gel". https://zelsuvmi.com/wp-content/uploads/2024/01/ZELSUVMI-Berdazimer-Topical-Gel-10.3.-Prescribing-Information-and-Instructions-for-Use.pdf.
- ↑ "GSRS". https://gsrs.ncats.nih.gov/ginas/app/beta/substances/ORT9SID4QY.
- ↑ 3.0 3.1 "Novel Drug Approvals for 2024". 5 January 2024. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-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. https://www.businesswire.com/news/home/20240105377376/en/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI%E2%84%A2-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018.
Further reading
- "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. 2023. doi:10.1111/pde.15419. PMID 37721050.
- "Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review". Journal of Drugs in Dermatology 22 (2): 182–189. February 2023. doi:10.36849/JDD.7230. PMID 36745361.
- "New Developing Treatments for Molluscum Contagiosum". Dermatology and Therapy 12 (12): 2669–2678. December 2022. doi:10.1007/s13555-022-00826-7. PMID 36239905.
- "The Antiviral Effect of Berdazimer Sodium on Molluscum Contagiosum Virus Using a Novel In Vitro Methodology". Viruses 15 (12): 2360. November 2023. doi:10.3390/v15122360. PMID 38140601.
External links
- "Berdazimer Sodium (Code C174810)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C174810.
- 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
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