A clinical study of inclisiran in patients with homozygous familial hypercholesterolemia

Trial Profile

A clinical study of inclisiran in patients with homozygous familial hypercholesterolemia

Planning
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2018

At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-5
  • Sponsors The Medicines Company
  • Most Recent Events

    • 08 Mar 2018 According to The Medicines Company media release, this trial is expected to enroll patients beginning later in 2018.
    • 20 Feb 2018 According to The Medicines Company media release, patient enrollment in the study may start in 2018.
    • 06 Nov 2017 According to The Medicines Company media release, the phase III program for inclisiran comprises four trials ORION-5, ORION-9, ORION-10 and ORION-11. The data from these trials will support the submission of a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in the European Union at or around the end of 2019. This trial is expected to begin before the end of 2017.
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