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

We are now navigating the final stages of regulatory review for this product – with an FDA approval date expected in 3Q 2023.

Sofpironium Bromide is a new chemical entity for which Botanix has successfully submitted a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA), and is preparing for the FDA’s mid-cycle review in 1Q 2023 which will substantially de-risk the approval for the product

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.