Sofpironium bromide is a proprietary new chemical entity that we are currently developing in the U.S. as a potential best-in-class, self-administered, once-daily, topical therapy for the treatment of primary axillary (underarm) hyperhidrosis. In October 2020, we initiated the pivotal Phase 3 program in the U.S. for sofpironium bromide, which will be comprised of two pivotal trials to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15% compared to vehicle (placebo) gel in approximately 350 subjects (per trial) aged 9 and older with primary axillary hyperhidrosis.
In addition, on September 25, 2020 we announced that our development partner, Kaken Pharmaceutical Co., Ltd., received regulatory approval to manufacture and market sofpironium bromide gel, 5% under the brand name ECCLOCK® in Japan for the treatment of primary axillary hyperhidrosis.
Sofpironium bromide was designed as a structural analog of a well-known potent anticholinergic, glycopyrrolate, to achieve its therapeutic effect at the application site (skin) similar to glycopyrrolate. However, it differs from glycopyrrolate in that sofpironium bromide was retrometabolically designed.