Bempedoic acid - Esperion Therapeutics
Alternative Names: ESP-55016; ETC-1002; NEXLETOL; NILEMDO; NilemdoLatest Information Update: 17 Apr 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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