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CER 001

Drug Profile

CER 001

Alternative Names: CER-001; Cerenis HDL; Recombinant Human Apolipoprotein A-I; Recombinant Human Apolipoprotein A-I/Phospholipids complex

Latest Information Update: 11 Sep 2019

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At a glance

  • Originator Cerenis Therapeutics
  • Developer ABIONYX Pharma; Academic Medical Center
  • Class Antihyperlipidaemics; Apolipoprotein therapeutics; Phospholipids; Recombinant proteins
  • Mechanism of Action Apolipoprotein A I stimulants
  • Orphan Drug Status

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

    Yes - Hypoalphalipoproteinaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hypoalphalipoproteinaemia
  • Phase II Acute coronary syndromes; Atherosclerosis
  • No development reported Lipid metabolism disorders

Most Recent Events

  • 11 Feb 2019 Cerenis Therapeutics terminates a phase III trial in Hypoalphalipoproteinaemia in Belgium, Brazil, Canada, France, Italy, Israel, Netherlands and USA due to lack of efficacy (NCT02697136)
  • 07 Dec 2018 Efficacy and safety data from a phase III TANGO trial in Hypoalphalipoproteinemia released by Cerenis Therapeutics
  • 07 Jul 2018 Cerenis therapeutics initiates a phase II imaging trial to assess tumour uptake of 89Zr-labeled CER 001 (In patients with Oesophageal cancer) (EudraCT: 2017-000724-10)
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