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Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Trial Profile

Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2016

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At a glance

  • Drugs Deoxycholic acid (Primary)
  • Indications Subcutaneous fat disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Kythera Biopharmaceuticals
  • Most Recent Events

    • 01 Jul 2016 According to an Allergan media release, the company has received positive opinion from the Swedish Medical Products Agency (MPA) for deoxycholic acid (BELKYRA) through European decentralised procedure for the treatment of subdermal fullness.
    • 23 Aug 2014 New source identified and integrated (European Clinical Trials Database record: EudraCT2010-020690-17)
    • 20 Oct 2013 New trial record
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