Berdazimer sodium
 | |
| 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 | |
| E number | {{#property:P628}} |
| CompTox Dashboard (EPA) |
|
| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 29: attempt to index field 'wikibase' (a nil value). |
| 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
[edit | edit source]Berdazimer sodium is indicated for the topical treatment of molluscum contagiosum.[1]
Pharmacology
[edit | edit source]Mechanism of action
[edit | edit source]Berdazimer sodium is a nitric oxide releasing agent.[1] The mechanism of action for the treatment of molluscum contagiosum is unknown.[1]
History
[edit | edit source]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
[edit | edit source]Legal status
[edit | edit source]Berdazimer sodium was approved for medical use in the United States in January 2024.[2][5]
Names
[edit | edit source]Berdazimer sodium is the international nonproprietary name.[8]
Berdazimer sodium is sold under the brand name Zelsuvmi.[1]
Research
[edit | edit source]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
[edit | edit source]- ^ a b c d e f g h i j k Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ a b c d e f g h i j Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
This article incorporates text from this source, which is in the public domain.
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ a b Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
Further reading
[edit | edit source]- Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
External links
[edit | edit source]- Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
- 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
Lua error in mw.title.lua at line 392: bad argument #2 to 'title.new' (unrecognized namespace name 'Portal'). Lua error in Module:Authority_control at line 153: attempt to index field 'wikibase' (a nil value).