Sofpironium bromide
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| Trade names | Ecclock, Sofdra |
| Other names | BBI-4000, BBI 4000 |
| License data | |
| Routes of administration | Topical |
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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 name Ecclock among others, is a medication used to treat hyperhidrosis (excessive sweating).[1] It is an anticholinergic and is applied to the skin.[1]
It was approved in Japan in 2020, for the treatment of primary axillary hyperhidrosis.[2][3][4] It was approved for medical use in the United States in June 2024.[1][5]
Medical uses[edit]
Sofpironium bromide is indicated for the treatment of primary axillary hyperhidrosis.[1]
Mechanism of action[edit]
Sofpironium bromide is an anticholinergic agent that reduces sweating by inhibiting M3 muscarinic receptors in eccrine glands.[4] It is a retrometabolically-designed drug (or "soft drug") based on glycopyrronium bromide,[6][7] meaning it has been designed to exert the desired effects at the site of administration, after which it is quickly converted into an inactive non-toxic metabolite upon entering systemic circulation avoiding the typical anticholinergic side-effects caused by off-site action.
Society and culture[edit]
Brand names[edit]
Sofpironium bromide is the international nonproprietary name.[8]
It is marketed as Ecclock in Japan and as Sofdra in the US.
References[edit]
- ^ a b c d e "Sofdra (sofpironium) topical gel, 12.45%" (PDF). Archived (PDF) from the original on 20 June 2024. Retrieved 20 June 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.
- ^ Gregoriou S, Campanati A, Rigopoulos D, Maria Offidani A, Stratigos A, Kontochristoulos G (May 2021). "Investigational topical anticholinergics in clinical development for the treatment of hyperhidrosis". Expert Opinion on Investigational Drugs. 30 (5): 479–482. doi:10.1080/13543784.2021.1900114. PMID 33691553. S2CID 232187568.
- ^ a b 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.
- ^ "FDA Approves Sofdra topical gel" (Press release). Botanix Pharmaceuticals. 20 June 2024. Archived from the original on 20 June 2024. Retrieved 20 June 2024.
- ^ Huang F, Brown CE, Wu WM, Juhász A, Ji F, Bodor N (October 2003). "Design, pharmacokinetic, and pharmacodynamic evaluation of a new class of soft anticholinergics". Pharmaceutical Research. 20 (10): 1681–9. doi:10.1023/a:1026160023030. PMID 14620526. S2CID 20657068.
- ^ Ji F, Wu W, Dai X, Mori N, Wu J, Buchwald P, et al. (November 2005). "Synthesis and pharmacological effects of new, N-substituted soft anticholinergics based on glycopyrrolate". J. Pharm. Pharmacol. 57 (11): 1427–35. doi:10.1211/jpp.57.11.0008. PMID 16259775.
- ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
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
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