Chemistry:Sofpironium bromide
From HandWiki
Short description: Chemical compound
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| Trade names | Ecclock, Sofdra, others |
| Other names | BBI-4000, BBI 4000 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624052 |
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| Routes of administration | Topical |
| Drug class | Anticholinergic |
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| Chemical and physical data | |
| Formula | C22H32BrNO5 |
| Molar mass | 470.404 g·mol−1 |
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Sofpironium bromide, sold under the brand names Ecclock and Sofdra 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 for medical use in Japan in 2020,[2] and in the United States in June 2024.[1][3][4][5]
Medical uses
Sofpironium bromide is indicated for the treatment of primary axillary hyperhidrosis.[1]
Mechanism of action
The pharmacodynamics of sofpironium bromide are unknown.[1]
Society and culture
Legal status
It was approved for medical use in Japan in November 2020,[6] and in the United States in June 2024.[1][7]
Brand names
Sofpironium bromide is the international nonproprietary name.[8]
It is sold under the brand name Ecclock in Japan and under the brand name Sofdra in the US.
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Sofdra- sofpironium bromide gel". 26 August 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=78f86f4f-658c-468b-bd54-49182ddcc7ac.
- ↑ "Sofpironium Bromide: First Approval". Drugs 80 (18): 1981–1986. December 2020. doi:10.1007/s40265-020-01438-1. PMID 33236266.
- ↑ "Drug Approval Package: Sofdra". 17 July 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217347Orig1s000TOC.cfm.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ "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". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
Further reading
- "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. March 2021. doi:10.1111/1346-8138.15668. PMID 33410265.
External links
- "Sofpironium Bromide (Code C152384)". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C152384.
- 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
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