Berdazimer sodium

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Berdazimer sodium
Berdazimer sodium.svg
Clinical data
Trade names Zelsuvmi
Other namesSB206
AHFS/Drugs.com Monograph
MedlinePlus a624007
License data
Routes of
administration 		Topical
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
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]

Contents

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

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. 1 2 3 4 5 6 7 8 9 10 11 "Zelsuvmi (berdazimer) topical gel" (PDF). Archived (PDF) from the original on 19 January 2024. Retrieved 9 January 2024.
  2. 1 2 3 4 5 6 7 8 9 10 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ "Berdazimer sodium". GSRS. Archived from the original on 8 January 2024. Retrieved 8 January 2024.
  4. ↑ "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.
  5. 1 2 "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.
  6. ↑ "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.
  7. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  8. ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl: 10665/330941 .
  9. ↑ Bhatt S, Kothari R, Tripathy DM, Sandhu S, Babaei M, Goldust M (September 2022). "Emerging drugs for the treatment of acne: a review of phase 2 & 3 trials". Expert Opinion on Emerging Drugs. 27 (3): 241–261. doi:10.1080/14728214.2022.2110239. PMID   35929974.
  10. ↑ Palaniappan V, Gopinath H, Karthikeyan K (20 January 2025). "Berdazimer Sodium: A Novel Nitric Oxide-Releasing Drug in Dermatology". Indian Dermatology Online Journal. doi: 10.4103/idoj.idoj_259_24 . ISSN   2229-5178.

Further reading

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