Sofpironium Bromide: First Approval

  title={Sofpironium Bromide: First Approval},
  author={Julia Paik},
  pages={1981 - 1986}
  • J. Paik
  • Published 24 November 2020
  • Biology
  • Drugs
Sofpironium bromide (ECCLOCK® in Japan) gel is a topical anticholinergic agent developed by Bodor Laboratories and licenced to Brickell Biotech for the treatment of hyperhidrosis. The drug is designed to reduce sweating by inhibiting M3 muscarinic receptors in eccrine glands at the application site. In September 2020, sofpironium bromide gel 5% received its first approval in Japan for the treatment of primary axillary hyperhidrosis (PAH). Clinical studies are currently ongoing in the USA to… 
4 Citations
Sofpironium bromide: an investigational agent for the treatment of axillary hyperhidrosis
An overview of pharmaceutical characteristics, efficacy and safety data from phase II and III clinical trials on sofpironium bromide (SB), a topical anticholinergic agent that has been employed for the treatment of PAH and has already received its first approval in Japan in the form of 5% gel formulation.
Topical anticholinergic medications for primary hyperhidrosis: A protocol for systematic review and meta-analysis
Evaluating systemic and topical safety and tolerability of topical application of anticholinergics for PHH and analysis of evidence for the efficacy and toleration is limited.
Synthetic Approaches to the New Drugs Approved During 2020.
This Review is part of a continuing series presenting the most likely process-scale synthetic approaches to 44 new chemical entities approved for the first time anywhere in the world during 2020.
Treatment of primary axillary hyperhidrosis with a cream formulation of oxybutynin chloride 10%
Glycopyrronium tosylate 3.75% cloth was FDA approved for the treatment of axillary hyperhidrosis in adults and children aged 9 years or older in 2018.


Hyperhidrosis: what is it and why does it occur?
A Comprehensive Approach to the Recognition, Diagnosis, and Severity‐Based Treatment of Focal Hyperhidrosis: Recommendations of the Canadian Hyperhidrosis Advisory Committee
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  • Medicine
    Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
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Clinical guidelines for the recognition, diagnosis, and treatment of primary focal hyperhidrosis are established using an evidence-based approach and offer a rapid method to assess disease severity and to treatment according to severity.
Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results.
The initial stages of the development and administration of a short, disease-specific, health related questionnaire to assess the impact of suffering from hyperhidrosis on the Quality of Life of patients who are anticipating surgery for this disorder showed that subjective QoL was significantly lower among females in four of the five life areas.
BBI-4000 (sofpironium bromide) demonstrates promising potential as a safe and effective first-line treatment for excessive underarm sweating [media release
  • 2016
Biotech announces positive phase 3 pivotal study results for sofpironium bromide in Japan released by development partner
  • Kaken Pharmaceutical [media release]
  • 2020
Biotech reports second quarter 2020 financial results and provides corporate update [media release
  • 2020
Biotech reports fourth quarter and full year 2019 financial results and provides corporate update [media release
  • 2020
Sofpironium bromide