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Ethyl eicosapentaenoic acid - Amarin

Drug Profile

Ethyl eicosapentaenoic acid - Amarin

Alternative Names: AMR-101; Eicosapentaenoic acid ethyl ester - Amarin; Eicosapentanoic acid ethyl ester; EPA-Vascepa; Ethyl eicosapentaenoate; Ethyl eicosopentaenoate; Ethyl icopenate; Ethyl-EPA; Icosapent ethyl - Amarin Corporation; Icosapentaenoic acid ethyl ester; LAX-101; LAX-101c; Miraxion™; Ultra-pure eicosapentaenoic acid; Ultra-pure EPA; Ultra-pure ethyl ecosapentaenoic acid; Ultra-pure ethyl EPA; Vascepa

Latest Information Update: 23 Oct 2019

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At a glance

  • Originator Scarista
  • Developer Amarin Corporation; Biologix FZCo; Eddingpharm; HLS Therapeutics; University of Leeds; Yorkshire Cancer Research
  • Class Antidepressants; Antihyperlipidaemics; Antineoplastics; Antiplatelets; Eicosanoids; Esters; Omega 3 fatty acids; Reactive oxygen species; Small molecules
  • Mechanism of Action Diacylglycerol O acyltransferase inhibitors; Phospholipase A2 inhibitors; Platelet aggregation inhibitors
  • Orphan Drug Status

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

    Yes - Huntington's disease
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Hypertriglyceridaemia
  • Phase III Colorectal cancer; Liver metastases
  • Discontinued Huntington's disease; Major depressive disorder; Memory disorders; Parkinson's disease; Psychotic disorders

Most Recent Events

  • 17 Oct 2019 PDUFA action date extended by US FDA to (28/12/2019) for sNDA for Hypertriglyceridaemia
  • 17 Oct 2019 Updated adverse events data from the phase III REDUCE-IT trial in Hypertriglyceridaemia released by Amarin Pharma
  • 31 Jul 2019 HLS Therapeutics anticipates approval of ethyl eicosapentaenoic acid for Hypertriglyceridaemia in Canada, in the fourth quarter of 2019
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