In May 2022, Botanix acquired the rights for a novel dermatology product called Sofpironium Bromide – a drug being developed to treat primary axillary hyperhidrosis, a medical condition where excessive sweating occurs beyond what is needed to maintain normal body temperature.

Sofpironium Bromide is now the most advanced product in our pipeline, with near term potential for significant revenue generation.

The product has promising potential as a best-in-class solution, backed by positive results from a Phase 3 pivotal clinical program, and has already been approved in Japan and launched by Botanix’s partner, Kaken Pharmaceutical Co., Ltd. (Ecclock®️ Sofpironium Bromide 5%).

Sofpironium Bromide is a new chemical entity for which Botanix is preparing to submit a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA) as a self-administered, once-daily, topical gel therapy. Sofpironium Bromide is delivered via a metered-dose pump with an applicator that allows patients to avoid direct contact with the hands and other body parts.

The NDA filing for Sofpironium Bromide Gel (15%) is planned for 2H 2022. We expect a 12-month review cycle and the first commercial launch in the US after FDA approval. Supported by our team of world-leading dermatology and commercialisation experts, Botanix is well-positioned to penetrate large and underserved global markets for this product.