Aquavit Pharmaceuticals, Inc. announced today that it has submitted its IND package (Investigation of New Drug) for a new botulinum toxin (DTX-021) to the FDA for approval.
DTX-021 is a botulinum toxin type A drug intended for the treatment of moderate to severe glabellar lines. DTX-021 is a highly purified and clinically tested injectable neuromodulator with a 900 kDa protein complex derived from neurotoxins produced by Clostridium botulinum.
Aquavit 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 US $5.3 billion dollar market with a CAGR of 7.8%, reaching US $9 billion dollars by 2026. According to The Aesthetic Society and Global Market Insights, botulinum toxin has been the #1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only 4 companies with approved botulinum toxin in the US.
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 the first-of-its-kind, world's first FDA approved pan-facial microinjection of neurotoxins. DTX-022 features a novel route of administration (RoA) of DTX-021 utilizing Aquavit's innovative microchannel delivery system, a patented "repeated motion" technology.
For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin. Aquavit is currently evaluating all other potential therapeutic indications of botulinum toxins.
"We are thrilled to present DTX-021 and DTX-022 programs at this year's AAD. 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." said Sobin Chang, CEO of Aquavit. "We plan to introduce the most innovative botulinum toxin programs to uplift and modernize the treatment paradigm"
Aquavit will officially unveil the Dermatox™ and Microtox™ programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA.