Sofdra™ (sofpironium) topical gel, 12.45% is a prescription anticholinergic medicine used on the skin in the armpits to treat excessive underarm sweating (primary axillary hyperhidrosis). It was approved by the US FDA in June 2024 and is meant to be used by adults and children 9 years and older. The active ingredient in Sofdra is sofpironium (sofpironium 12.45%, also known as sofpironium bromide 15%). Sofpironium bromide is designed as a structural analog of anticholinergic glycopyrrolate. For more details, check out the product website, the prescription version of the site and the official FDA Sofdra drug facts document.
Update -- December 2024: A new systemic review of five studies concluded that sofpironium gel provides notable improvements in underarm sweat reduction and symptom severity. The side effects were mostly mild and localized.
Unlike traditional extra-strength antiperspirants, Sofdra gel does not contain any aluminum. Moreover, its active ingredient sofpironium is an anticholinergic. Note that using a topical anticholinergic is likely to lead to far fewer systemic side effects in comparison to ingesting an oral anticholinergic such as Robinul Forte. Do note that since 2018, patients in the US can also purchase QBREXZA cloths with glycopyrronium 2.4% for their excessive armpit sweating. Only via a doctor's prescription.
The most common side effects from Sofdra include:
More serious issues that require immediate medical attention include:
US-based Brickell Biotech's sofpironium bromide (BBI-4000) gel successfully completed two separate clinical trials in 2021 that showed reduced armpit sweat production. Even prior to this, in September 2020, Brickell's Japanese partner Kaken Pharmaceutical received regulatory approval to manufacture and market sofpironium Bromide gel 5% (under the brand name ECCLOCK®) for daily treatment of primary axillary hyperhidrosis. This marked the first commercial use of sofpironium bromide for any indication worldwide. An April 2022 study from Japan found that after just 1 week of treatment with sofpironium, 50% of patients saw a clinically significant improvement in primary axillary hyperhidrosis. In May 2022, Brickell sold the rights to this product to Botanix Pharmaceuticals (Australia). And in June 2024, the US FDA approved Botanix Pharmaceutical's sofpironium (Sofdra) topical gel, 12.45% to treat primarily axillary hyperhidrosis in adults and children ages 9 and older. It is the first and only chemical entity approved for excessive underarm sweating.