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A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome

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Trial Profile

A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jan 2025

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At a glance

  • Drugs Plozasiran (Primary)
  • Indications Hyperlipoproteinaemia type I
  • Focus Registrational; Therapeutic Use
  • Acronyms PALISADE
  • Sponsors Arrowhead Pharmaceuticals

Most Recent Events

  • 17 Jan 2025 According to an Arrowhead Pharmaceuticals media release, currently the USFDA is not planning to hold an advisory committee meeting and Arrowhead also intends to submit applications for approval of investigational plozasiran for the treatment of patients with FCS to additional regulatory authorities in 2025.
  • 17 Jan 2025 According to an Arrowhead Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025.
  • 02 Dec 2024 According to an Arrowhead Pharmaceuticals media release, data from this trial will be presented at APA/JPS/CAP/IAP 2024 Joint Meeting, 21st Global CVCT Forum and 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

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