Aquavit Files IND with FDA for DTX-021, a New Botulinum Toxin

Posted By American Med Spa Association, Wednesday, April 6, 2022

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.

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