Botanix is focused on the regulatory approval and commercialisation of its lead dermatology product, Sofdra™, a drug for the treatment of primary axillary hyperhidrosis, a medical condition where excessive sweating occurs in the armpits.

Sofdra is a new chemical entity for the treatment of primary axillary hyperhidrosis for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA). We expect FDA approval in mid-2024 after satisfying issues raised by the FDA in a Complete Response Letter primarily regarding Instructions for Use and minor wording changes to the carton and bottle label. The letter did not identify any other deficiencies in the NDA.

Supported by our team of world-leading dermatology and commercialisation experts, Botanix is ideally positioned to penetrate large and underserved global markets for this product, with scope 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%). 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. A point of difference that sets it apart from current products on market – for both patient use and drug efficacy.