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Olezarsen - Ionis Pharmaceuticals

Drug Profile

Olezarsen - Ionis Pharmaceuticals

Alternative Names: AKCEA-APOCIII-LRx; GalNAc3 conjugated antisense oligonucleotide - Ionis Pharmaceuticals; IONIS-APOCIII-LRx; IONISAPOCIII-LRx, sodium salt; ISIS 678354; ISIS-APOCIII-LRx; Olezarsen sodium

Latest Information Update: 30 Nov 2023

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At a glance

  • Originator Ionis Pharmaceuticals
  • Developer Akcea Therapeutics; Ionis Pharmaceuticals
  • Class Antihyperlipidaemics; Antisense oligonucleotides
  • Mechanism of Action Apolipoprotein C III expression inhibitors; RNA interference
  • 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

  • Phase III Cardiovascular disorders; Hyperlipoproteinaemia type I; Hypertriglyceridaemia

Most Recent Events

  • 17 Oct 2023 Ionis Pharmaceuticals completes a phase-III clinical trials in Hyperlipoproteinaemia type I in Canada, Germany, France, Hungary, Israel, Italy, Norway, Portugal, Slovakia, Spain, Sweden, UK, Netherlands and USA (SC) (NCT04568434)
  • 26 Sep 2023 Ionis Pharmaceuticals announces intention to submit regulatory applications to the EU regulatory body for Hyperlipoproteinaemia type I in European Union, in early 2024 or beyond
  • 26 Sep 2023 Ionis Pharmaceuticals announces intention to submit NDA to the US FDA for Hyperlipoproteinaemia type I in USA, in early 2024
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