Mature Product Pipeline

The primary asset in Botanix’s pipeline is Sofdra™ (sofpironium bromide) gel, 15%, a new chemical entity for which we have successfully submitted a New Drug Application (NDA) for US regulatory approval with the FDA. Three other clinical-stage programs have completed, or are currently undergoing Phase 2 studies, for dermatology and antimicrobial indications.

Indication Product Phase 1 Phase 1b Phase 2 Phase 3 Approved Status
Axillary Hyperhidrosis (excessive underarm sweating) Sofdra gel
Expecting FDA approval mid-2024
Moderate to severe acne BTX 1503
Pending Phase 3 study
Rosacea BTX 1702
Positive Phase 1b/2 results
Atopic dermatitis BTX 1204A
Canine proof-of-concept study complete
Antimicrobial BTX 1801
Phase 2a study (successfully completed).
Phase 2b study (pending).