DTX-021 is a botulinum toxin that is an injectable neuromodulator derived from neurotoxins produced by Clostridium botulinum, the bacterium responsible for botulism. Through the inhibition of neurotransmission between peripheral nerve endings and muscle fibers, the botulinum toxin weakens or paralyzes skeletal muscle. The effects of botulinum toxin are transient; muscular function typically returns to baseline within a few months.
DTX-021, has shown equivalency to onabotulinumtoxinA (BOTOX®) on treating glabellar lines and improvement on periorbital rhytids. It was proven through a multi-center, double-blind, randomized, parallel, active-controlled phase III clinical trial, with no adverse events reported. The results of the study have been published in the American Society for Dermatologic Surgery (ASDS).
Aquavit plans to file an IND to initiate clinical trial enrollment and support towards the BLA submission process with the FDA, for the novel treatment of skin health as the initial indication, followed by a 351(k) Biosimilar pathway for all other existing aesthetic and therapeutic indications such as: