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Bempedoic acid/ezetimibe - Esperion Therapeutics

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Drug Profile

Bempedoic acid/ezetimibe - Esperion Therapeutics

Alternative Names: ETC-1002/ezetimibe; Ezetimibe/bempedoic acid; Ezetimibe/ETC-1002; NEXLIZET; Nustendi

Latest Information Update: 26 Mar 2024

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At a glance

  • Originator Esperion Therapeutics
  • Developer Daiichi Sankyo Europe; Esperion Therapeutics
  • Class Antihyperlipidaemics; Azetidines; Dicarboxylic acids; Fatty acids; Fluorobenzenes; Propanols; Small molecules
  • Mechanism of Action AMP activated protein kinase stimulants; ATP citrate (pro S) lyase inhibitors; Cholesterol absorption inhibitors; Cholesterol synthesis inhibitors; NPC1L1 protein inhibitors; Peroxisome proliferator-activated receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Dyslipidaemias; Hypercholesterolaemia
  • Preregistration Cardiovascular disorders

Most Recent Events

  • 21 Mar 2024 Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for bempedoic acid/ezetiibe in Cardiovascular disorders
  • 07 Mar 2024 FDA assigns PDUFA action date of 31/03/2024 for Bempedoic acid/ezetimibe for Cardiovascular disorders
  • 06 Mar 2024 Esperion Therapeutics has patent protection for bempedoic acid / ezetimibe combination tablet in combination with one or more statins and for methods of treating familial hypercholesterolemia in USA, prior to March 2024
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