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A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG

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Trial Profile

A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2023

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At a glance

  • Drugs Bempedoic acid (Primary)
  • Indications Hypercholesterolaemia
  • Focus Adverse reactions; Registrational
  • Acronyms CLEAR Harmony OLE
  • Sponsors Esperion Therapeutics

    • Most Recent Events

    • 01 Aug 2023 According to an Esperion AB Media Release, the company announced the submission of its Supplemental New Drug Applications (sNDAs) for NEXLETOL and NEXLIZET to the Food and Drug Administration (FDA), and the submission of an application for expanded indication for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe) to the European Medicines Agency (EMA).The Company anticipates approvals in both the U.S. and Europe in the first half of 2024.
    • 25 Apr 2022 Results published in the American Journal of Cardiology
    • 16 Dec 2020 According to a Daiichi Sankyo Company media release, NILEMDO (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI (bempedoic acid and ezetimibe) tablet has been approved in Switzerland by the Swissmedic for the treatment of people with high low-density lipoprotein cholesterol (LDL-C). Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.
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