Study: Sofpironium Gel Effective for Axillary Hyperhidrosis

Key Takeaways

• Sofpironium 12.45% gel met all co-primary and secondary endpoints in a new pooled phase 3 analysis.

• Improvements in severity and sweat production were seen in all subgroups.

• The treatment was well-tolerated, with manageable side effects. 

Sofpironium topical gel, 12.45%, showed efficacy and tolerability in treating primary axillary hyperhidrosis, according to pooled results from two pivotal Phase 3 trials.

Researchers for the combined analysis of the Cardigan I and II studies looked at the effectiveness of once-daily sofpironium gel vs. a vehicle gel in 701 subjects aged 9 years and older with moderate to severe axillary hyperhidrosis. 353 patients were assigned to the treatment group with 348 controls. Co-primary endpoints included ≥2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax-7) and a reduction in gravimetric sweat production (GSP).

The treatment group achieved significantly better outcomes on both counts (P < .0001 for HDSM-Ax-7; P = .0002 for GSP). Secondary endpoints acheived sustained improvement in all demographic subgroups. The most frequent adverse events included dry mouth, application site discomfort, and blurred vision. 

"Sofpironium topical gel, 12.45%, applied topically once daily before bedtime is effective and well-tolerated for treatment of primary axillary hyperhidrosis in patients 9 years of age or older," the authors wrote.

Source:  Pariser D, et al. JAAD. 2025. doi:10.1016/j.jaad.2025.02.086