Berdazimer sodium

Berdazimer sodium
Clinical data
Trade namesZelsuvmi
Other namesSB206
AHFS/Drugs.comMonograph
MedlinePlusa624007
License data
Routes of
administration		Topical
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaIndeterminate[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]

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.[7]

Berdazimer sodium is sold under the brand name Zelsuvmi.[1]

References

  1. ^ 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.
  2. ^ 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. Public Domain 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. ^ 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.
  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. ^ 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