ATX-101 Fast Facts
What is ATX-101?
ATX-101 is a patented formulation of deoxycholic acid, manufactured without animal-derived substances to the highest standards of purity and quality. If approved, ATX-101 would be a less-invasive, non-surgical option for the treatment of submental fullness. ATX-101 has been under development for more than 8 years, and the subject of 19 clinical studies involving more than 2,600 patients.
What is Submental Fullness?
Submental fullness associated with subcutaneous fat can detract from an otherwise balanced and harmonious facial appearancei – leading to an older and heavier look.ii
Who is Affected by Submental Fullness?
According to a 2014 survey by the American Society for Dermatologic Surgery, 7 out of 10 consumers are bothered by submental fullness.iii
Is ATX-101 Available?
No. ATX-101 is not currently approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. KYTHERA is engaged in a robust global clinical development program for ATX-101. A New Drug Application (NDA) was submitted to the FDA in May 2014. A New Drug Submission was submitted to Health Canada in August 2014 and a Marketing Authorization Application (MAA) was submitted in October 2014 in Switzerland. Additionally, a New Drug Submission was submitted to the Therapeutic Goods Administration (TGA) in Australia in February 2015.
ATX-101 is not currently approved by the FDA or any other regulatory authority