title: Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat.
abstract: In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat. ATX-101 has been evaluated in a clinical development program that included 18 Phase 1 to 3 studies supporting the current indication. Since 2007, the toxicity and safety profiles of ATX-101 have been characterized in numerous preclinical studies, its pharmacokinetics, pharmacodynamics, and optimal treatment paradigm have been defined in multiple Phase 1 and 2 studies, and its efficacy and clinical safety have been confirmed in 4 large Phase 3 trials (2 conducted in Europe and 2 in the United States and Canada [REFINE-1 and REFINE-2]). As subcutaneous injection of deoxycholic acid has been shown to cause adipocytolysis, the reduction in submental fat achieved after ATX-101 treatment is expected to be long lasting. This prediction is confirmed by data from long-term follow-up studies of up to 4 years after last treatment with ATX-101, which demonstrate that the treatment response is maintained over time in most subjects. ATX-101 offers a durable, minimally invasive alternative to liposuction and surgery for addressing submental fullness.
authors: *Departments of Otolaryngology and Dermatology, University of Illinois and Private Practice (SDMD), Chicago, Illinois; †Department of Dermatology and Skin Science, University of British Columbia and Private Practice (Carruthers and Humphrey), Vancouver, British Columbia, Canada; ‡Deparment of Dermatology, University of California Los Angeles and Private Practice (Skin Care and Laser Physicians of Beverly Hills), Los Angeles, California; §Allergan plc, Irvine, California; ‖Evidence Scientific Solutions, Philadelphia, Pennsylvania; ¶Department of Dermatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California. Drs. Lizzul, Gross, and Beddingfield are former employees of Allergan plc. Current affiliation for Drs. Lizzul and Beddingfield is Sienna Biopharmaceuticals, Inc., Westlake Village, California. Current affiliation for Dr. Gross is Department of Statistics and Applied Probability, University of California Santa Barbara, Santa Barbara, California.
authors: Steven H
authors: SH
authors: Dayan
authors: Shannon
authors: S
authors: Humphrey
authors: Derek H
authors: DH
authors: Jones
authors: Paul F
authors: PF
authors: Lizzul
authors: Todd M
authors: TM
authors: Gross
authors: Karen
authors: K
authors: Stauffer
authors: Frederick C
authors: FC
authors: Beddingfield
mesh_terms: D002680:Chin; D002986:Clinical Trials as Topic; D003357:Cosmetic Techniques; D003840:Deoxycholic Acid / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D050151:Subcutaneous Fat / Q000187:drug effects*
chemical_list: C000599116:ATX-101 compound; D003879:Dermatologic Agents; D003840:Deoxycholic Acid