Chemistry:Berdazimer sodium
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| Clinical data | |
|---|---|
| Trade names | Zelsuvmi |
| Other names | SB206 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624007 |
| License data | |
| Routes of administration | Topical |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
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| ChEMBL | |
| 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.[3]
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] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
Medical uses
Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum.[1]
Pharmacology
Mechanism of action
Berdazimer sodium is a nitric oxide releasing agent.[1] The mechanism of action for the treatment of molluscum contagiosum is unknown.[1]
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.[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
Legal status
Berdazimer sodium was approved for medical use in the United States in January 2024.[2][5]
Names
Berdazimer sodium is the international nonproprietary name.[8]
Berdazimer sodium is sold under the brand name Zelsuvmi.[1]
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.[9][10]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 "Zelsuvmi- berdazimer kit". 28 March 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76b17622-bdb9-41ea-b962-c2acc0df71f7.
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 "Drug Trials Snapshots: Zelsuvmi". 5 January 2024. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zelsuvmi.
This article incorporates text from this source, which is in the public domain.
- ↑ "Berdazimer sodium". https://gsrs.ncats.nih.gov/ginas/app/beta/substances/ORT9SID4QY.
- ↑ "Drug Approval Package: Zelsuvmi". 2 February 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217424Orig1s000TOC.cfm.
- ↑ 5.0 5.1 "Novel Drug Approvals for 2024". 29 April 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/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.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018.
- ↑ "Emerging drugs for the treatment of acne: a review of phase 2 & 3 trials". Expert Opinion on Emerging Drugs 27 (3): 241–261. September 2022. doi:10.1080/14728214.2022.2110239. PMID 35929974.
- ↑ "Berdazimer Sodium: A Novel Nitric Oxide-Releasing Drug in Dermatology". Indian Dermatology Online Journal 16 (2): 359–362. 20 January 2025. doi:10.4103/idoj.idoj_259_24. ISSN 2229-5178. PMID 40125066.
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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