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Sofpironium bromide

Clinical data
Trade names	Ecclock, others
Other names	BBI-4000, BBI 4000
AHFS/Drugs.com	Monograph
License data	US DailyMed: Sofpironium bromide
Routes of administration	Topical
Drug class	Anticholinergic
ATC code	None
Legal status
Legal status	US: ℞-only JP: Rx-only
Identifiers
IUPAC name (2R)-2-cyclopentyl-2-hydroxy-2-phenylacetate bromide
CAS Number	1628106-94-4
PubChem CID	86301316
DrugBank	DB19325
ChemSpider	52085312
UNII	7B2Y1932XU
KEGG	D10989
ChEMBL	ChEMBL3707223
Chemical and physical data
Formula	C22H32BrNO5
Molar mass	470.404 g·mol
3D model (JSmol)	Interactive image
SMILES CCOC(=O)C1(CC(C1)OC(=O)(C2CCCC2)(C3=CC=CC=C3)O)C.
InChI InChI=1S/C22H32NO5.BrH/c1-3-27-20(24)16-23(2)14-13-19(15-23)28-21(25)22(26,18-11-7-8-12-18)17-9-5-4-6-10-17;/h4-6,9-10,18-19,26H,3,7-8,11-16H2,1-2H3;1H/q+1;/p-1/t19-,22+,23?;/m1./s1 Key:FIAFMTCUJCWADZ-JOFREBOKSA-M

Sofpironium bromide, sold under the brand name Ecclock among others, is a medication used to treat hyperhidrosis (excessive sweating). Sofpironium bromide is an anticholinergic agent that is applied to the skin.

It was approved in Japan in 2020, for the treatment of primary axillary hyperhidrosis. It was approved for medical use in the United States in June 2024.

Medical uses

Sofpironium bromide is indicated for the treatment of primary axillary hyperhidrosis.

Mechanism of action

The pharmacodynamics of sofpironium bromide are unknown.

Society and culture

Legal status

It was approved for medical use in Japan in November 2020, and in the United States in June 2024.

Brand names

Sofpironium bromide is the international nonproprietary name.

It is sold under the brand name Ecclock in Japan and under the brand name Sofdra in the US.

References

1. ^ "Sofdra- sofpironium bromide gel". DailyMed. 26 August 2024. Retrieved 2 September 2024.
2. Paik J (December 2020). "Sofpironium Bromide: First Approval". Drugs. 80 (18): 1981–1986. doi:10.1007/s40265-020-01438-1. PMID 33236266. S2CID 227155835.
3. "Drug Approval Package: Sofdra". U.S. Food and Drug Administration (FDA). 17 July 2024. Retrieved 2 September 2024.
4. "FDA Approves Sofdra topical gel" (Press release). Botanix Pharmaceuticals. 20 June 2024. Archived from the original on 20 June 2024. Retrieved 20 June 2024.
5. "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.
6. "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
7. 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

• 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

• "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

• Medicine

• Drugs not assigned an ATC code
• Dermatologic drugs
• Muscarinic antagonists
• Quaternary ammonium compounds
• Bromides
• Pyrrolidines
• Tertiary alcohols
• Carboxylate esters
• Ethyl esters
• Cyclopentyl compounds