Sofpironium bromide

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 [(3R)-1-(2-Ethoxy-2-oxoethyl)-1-methylpyrrolidin-1-ium-3-yl] (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−1
3D model (JSmol)	Interactive image;
	SMILES CCOC(=O)C[N+]1(CC[C@H](C1)OC(=O)[C@@](C2CCCC2)(C3=CC=CC=C3)O)C.[Br-];
	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).^[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

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,^[5] and in the United States in June 2024.^[1]^[6]

Brand names

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

^ ^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.

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

[Sofdra_FDA_label-1] ^ ^a ^b ^c ^d ^e ^f ^g "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.

[Novel_Drug_Approvals_for_2024-6] "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.

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