Aquavit Pharmaceuticals, Inc. has submitted to the U.S. FDA an Investigation of New Drug (IND) package for a new botulinum toxin, DTX-021.
DTX-021 is a botulinum toxin type A drug intended for the treatment of moderate to severe glabellar lines. Aquavit officials say it’s a highly purified and clinically tested injectable neuromodulator with a 900 kDa protein complex derived from neurotoxins produced by Clostridium botulinum. The company will be initiating a long-term Phase-II clinical trial shortly after the approval of the IND.
With the FDA’s final approval, DTX-021 (to be marketed as Dermatox™) will enter the fast-growing $5.3 billion dollar market with a compound annual growth rate of 7.8%, reaching $9 billion dollars by 2026. According to The Aesthetic Society and Global Market Insights, botulinum toxin has been the No.1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only four companies with approved botulinum toxin in the U.S.
Aquavit is accelerating its clinical development program by introducing DTX-022 (to be marketed as Microtox™) shortly after DTX-021. With final approval of DTX-022, it will be an FDA approved pan-facial microinjection of neurotoxins. DTX-022 features a new route of administration (RoA) of DTX-021 utilizing Aquavit’s microchannel delivery system, a patented “repeated motion” technology.
Company officials say Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin for several years. Aquavit is currently evaluating all other potential therapeutic indications of botulinum toxins.
“With Aquavit’s proven track record of developing and launching a global brand such as AquaGold®, combined with our network of physicians and knowledge of botulinum toxins, we are poised to make a significant impact in the fast-growing multi-billion-dollar neurotoxin market,” says Aquavit CEO Sobin Chang. “We plan to introduce the most innovative botulinum toxin programs to uplift and modernize the treatment paradigm.”