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Bempedoic acid - Esperion Therapeutics

Drug Profile

Bempedoic acid - Esperion Therapeutics

Alternative Names: ESP-55016; ETC-1002; NEXLETOL; NILEMDO; Nilemdo

Latest Information Update: 17 Apr 2025

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At a glance

  • Originator Esperion Therapeutics
  • Developer Daiichi Sankyo Europe; Esperion Therapeutics; Otsuka Pharmaceutical
  • Class Antihyperlipidaemics; Antihypertensives; Dicarboxylic acids; Fatty acids; Small molecules
  • Mechanism of Action AMP activated protein kinase stimulants; ATP citrate (pro S) lyase inhibitors
  • Orphan Drug Status

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

    Yes - Hyperlipoproteinaemia type II
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Dyslipidaemias; Hypercholesterolaemia
  • Registered Cardiovascular disorders
  • Preregistration Hyperlipoproteinaemia type IIa
  • No development reported Hypertension

Most Recent Events

  • 20 Mar 2025 Esperion announced meetings with the US FDA it has gained alignment on a regulatory path forward for initiating Phase 3 studies of bempedoic acid
  • 20 Mar 2025 Esperion aligns with US FDA plans to initiate a phase III trial for Bempedoic acid in pediatric heterozygous and homozygous familial hypercholesterolemia (In children, Monotherapy, Combination therapy) in 2025
  • 20 Mar 2025 Esperion plans New Drug Applications for Hypercholesterolemia in Australia and Israel by in the first half of 2025

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