Sofpironium bromide
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| Clinical data | |
|---|---|
| Trade names | Ecclock, others |
| Other names | BBI-4000, BBI 4000 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Topical |
| Drug class | Anticholinergic |
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| Legal status | |
| Legal status | |
| Identifiers | |
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| CAS Number | |
| PubChem CID | |
| DrugBank | |
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| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C22H32BrNO5 |
| Molar mass | 470.404 g·mol−1 |
| 3D model (JSmol) | |
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Sofpironium bromide, sold under the brand name Ecclock among others, is a medication used to treat hyperhidrosis (excessive sweating).[1] Sofpironium bromide is an anticholinergic agent that is applied to the skin.[1]
It was approved in Japan in 2020, for the treatment of primary axillary hyperhidrosis.[2] It was approved for medical use in the United States in June 2024.[1][3][4]
Medical uses
[edit]Sofpironium bromide is indicated for the treatment of primary axillary hyperhidrosis.[1]
Mechanism of action
[edit]The pharmacodynamics of sofpironium bromide are unknown.[1]
Society and culture
[edit]Legal status
[edit]It was approved for medical use in Japan in November 2020,[5] and in the United States in June 2024.[1][6]
Brand names
[edit]Sofpironium bromide is the international nonproprietary name.[7]
It is sold under the brand name Ecclock in Japan and under the brand name Sofdra in the US.
References
[edit]- ^ a b c d e f g "Sofdra- sofpironium bromide gel". DailyMed. 26 August 2024. Retrieved 2 September 2024.
- ^ Paik J (December 2020). "Sofpironium Bromide: First Approval". Drugs. 80 (18): 1981–1986. doi:10.1007/s40265-020-01438-1. PMID 33236266. S2CID 227155835.
- ^ "Drug Approval Package: Sofdra". U.S. Food and Drug Administration (FDA). 17 July 2024. Retrieved 2 September 2024.
- ^ "FDA Approves Sofdra topical gel" (Press release). Botanix Pharmaceuticals. 20 June 2024. Archived from the original on 20 June 2024. Retrieved 20 June 2024.
- ^ "Brickell Biotech Announces Launch Date for Sofpironium Bromide Gel, 5% (Ecclock) in Japan by its Development Partner, Kaken Pharmaceutical" (Press release). Brickell Biotech. 18 November 2020. Retrieved 2 September 2024 – via GlobeNewswire.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
- ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
Further reading
[edit]- Yokozeki H, Fujimoto T, Abe Y, Igarashi M, Ishikoh A, Omi T, et al. (March 2021). "A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis". The Journal of Dermatology. 48 (3): 279–288. doi:10.1111/1346-8138.15668. PMC 7986147. PMID 33410265.
External links
[edit]- "Sofpironium Bromide (Code C152384)". NCI Thesaurus.
- Clinical trial number NCT03836287 for "Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (CardiganI)" at ClinicalTrials.gov
- Clinical trial number NCT03948646 for "Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (CARDIGANII)" at ClinicalTrials.gov
